Changes In INR Research Articles

Anticoagulant drug-drug interactions with cannabinoids: Asystematic review.

This systematic review evaluates the extent to which the effect of anticoagulants may be altered in the presence of cannabinoids. The following databases were searched: EMBASE, PubMed, Web of Science, Scopus, PscycINFO, and CINAHL from database inception through May 2023. Search terms included cannabis AND anticoagulant AND drug interactions and related keywords. The major outcome was hemorrhage or thrombosis and if available the relative change in quantitative intensity of anticoagulation after cannabinoid exposure. The search generated 959 citations. After the removal of 440 duplicates, 519 citations were screened. Overall, with the exception of warfarin, evidence supporting an interaction between cannabinoids and anticoagulants is non-existent. Seven case reports evaluating an interaction with warfarin were reported. Cannabis doses involved were either extremely high (e.g., >260 mg/day of delta-9-tetrahydrocannabidiol [THC] or >600 mg/day of cannabidiol [CBD]) or were not known. Hemorrhage was identified in 14.2% (1/7) of reports and thrombosis in 0%. Quantitative anticoagulation levels were increased in patients on warfarin (elevated International Normalized Ratio [INR]) in six of seven cases. A maximum INR change was available in five of seven reports, ranging from +0.4 to +9.61. One report found no change in INR after 4 days of medical cannabis exposure. Another report outlined two separate episodes of INR elevation associated with bleeding requiring hospitalization and reversal after marijuana smoking. Four cases involved reduction in weekly warfarin dose ranging from 22% to 31%. The Drug Information Probability Score was calculated in six cases, with a score of probable for five cases and possible for one. Very low-quality data support a potential drug-drug interaction with warfarin and both THC and CBD. Clinician recognition of this potential interaction is important. Available evidence supports the need to conduct a drug interaction study between cannabinoids and warfarin to clarify the existence of an interaction.

Prevalence of Coagulopathy in Patients with Celiac Disease: A Single-Center Retrospective Case-Control Study

Introduction: Despite being one of the most frequent chronic digestive diseases worldwide, with a prevalence of 1%, celiac disease (CD) remains severely underdiagnosed. Among the instruments used to improve its diagnostic rate, hematologic parameters have been proposed as screening tests to select patients with an increased probability of having CD. Assessment of coagulation is included in routine check-ups, and CD has been reported to be associated with coagulopathy. We aimed to assess if subtle changes in coagulation tests could be used in clinical practice to prompt testing for CD. Methods: We retrospectively recruited all patients with clinical suspicion for CD during a study period of 7 years (between 2015 and 2022), who were tested using IgA tissue transglutaminase (tTG) serology and serum total IgA (IgG tTG in case of IgA deficiency) and who underwent upper gastrointestinal endoscopy with multiple biopsy sampling of the duodenal bulb and distal duodenum. We stratified patients into three groups: newly diagnosed CD, gluten-free diet-treated CD, and non-CD controls. Results: Altogether, there were 133 CD patients (71 newly diagnosed, 62 GFD-treated) and 57 non-CD controls. Mean age and gender distribution were similar among the three groups: 43.3 years for newly diagnosed CD, 41.6 years for non-CD controls, and 44 years for GFD-treated CD patients, with a male gender distribution of 21.1%, 28%, and 24.1%, respectively. Among the included newly diagnosed CD patients, 14% had a prolonged INR. The mean INR was slightly higher in newly diagnosed CD patients, compared to GFD-treated CD patients and non-CD controls: 1.12 ± 0.30, 1.02 ± 0.83, and 1.00 ± 0.08, respectively (p = 0.009). Consequently, prothrombin activity was slightly lower in newly diagnosed CD patients, compared to GFD-treated CD and non-CD controls: 94.9 ± 19.3%, 102.3 ± 12.8%, and 101.9 ± 15.15, respectively. Interestingly, after GFD, the mean INR and prothrombin activity of CD individuals reached a value similar to that of non-CD controls. Conclusions: Subtle changes in INR, defined as a value within the normal range, but closer to the upper limit, could be an indicator of probability for CD.

Directly Acting Anti-Viral Drugs and Its Metabolic Side Effects in Patients with Chronic HCV

Abstract Background Hepatitis C virus (HCV) infection is still one of the leading causes of chronic liver disease, with chronically infected making up approximately 1% of the global population. Aim and Objectives The aim of this work was to study side effects of directly acting anti HCV drug (DAA) and its progression in metabolism of lipid profile, blood sugar level, and renal function. Subjects and Methods This case study had been carried out on 200 subjects presented to Department of Internal Medicine at Kobbri ELkobba hospital inpatient and outpatient clinics between March 2016 and September 2016. All subjects participating in the study was asked to sign informed concept before inclusion. Results There are non-significant changes in liver enzymes, AST, ALT, INR, and CBC. But in lipid profile, non-significant changes in HDL, But noticed significant decrease in LDL and significant increase in TG from (172.53 ± 36.11) to (267.84 ± 63.24 ) and Total cholesterol, significant increase from (203.60 ± 53.85) to ( 216.15 ±55.67). In HbA1C, there was significant increase. Conclusion Once-daily oral daclatasvir plus sofosbuvir with or without Ribavirin was associated with high rates of sustained virologic response among patients infected with HCV, including chronic cirrhotic patients and relapsers, successful treatment associated with Improvement of liver function parameters in the majority of patients, Increase in urea level, serum creatinin and HbA1C. There is significant decrease in LDL and mild increase in TG level.

Anticoagulation decision-making before non-cardiac surgery in patients with mechanical heart valve: A retrospective study

ObjectiveTo clarify the timing of warfarin discontinuation at different ranges of INR. Improve anticoagulation management in non-cardiac surgical patients with MHV. DesignThis is a single-center retrospective observational study. Settingand participants This study used data from the Hospital Information System, and the Surgery and Anesthesia Information System of the Second Affiliated Hospital of Army Military Medical University. Participants included 121 adult patients with MHV who underwent non-cardiac surgery from 2012 to 2021. ResultsOverall, 121 patients with MHV (15 aortic valve only, 56 mitral valve only, and 50 with multiple valves) underwent non-cardiac surgery. When the duration of warfarin discontinuation was ≤ 3 days, 3−5 days, and≥5 days, the INR was 1.45, 1.15, and 1.09, respectively. Bleeding between INR ≤1.2 and INR >1.2 groups was not statistically significant using Student's t-test (95% CI −0.57, 0.14 P = 0.24). Multivariate regression analysis revealed that Intraoperative bleeding volume correlated with preoperative albumin levels (OR = 0.68，95% CI 0.49, 0.89). ConclusionsWhen need preoperative INR is less than 1.5 in patients with MHV undergoing non-cardiac surgery, preoperative warfarin discontinuation for 3 days is sufficient. If INR less than 1.2, preoperative warfarin discontinuation for 3–5 days is appropriate. And in patients with MHV underwent abdominal surgery, intraoperative bleeding is not significant reduced by lower INR after preoperative warfarin discontinuation. Furthermore, the effect of albumin levels on coagulation function cannot be ignored in patients with MHV. Strengths and limitationsThis study was derived from real-world clinical data. It's a retrospectively study to describe the INR changed according to the duration of warfarin discontinuation in patients with MHV and compared intraoperation of bleeding volume between INR>1.2 and INR ≤ 1.2after warfarin discontinuation. To clarify the timing of warfarin discontinuation at different ranges of INR. Improve anticoagulation management in non-cardiac surgical patients with MHV, while providing clinicians with a reference for preoperative warfarin adjustment. This study does have a few limitations. The number of cases is small because patients undergoing repeat noncardiac surgery after heart valve surgery are a special case population. And the patients were not followed up after non-cardiac surgery. The impact of changes in INR on postoperative complications could not be assessed in patients with MHV.

Standard volume plasma exchange is safe and effective for patients with acute liver failure.

Background and Aim: Plasma exchange (PLEX) is an effective bridging therapy for patients with acute liver failure(ALF). There are no studies comparing the efficacy of standard volume (SV) vs. high volume (HV) PLEX. Therefore, we aimed to compare the safety and efficacy of SV PLEX with HV PLEX. Methods: Patients with ALF who underwent PLEX were included in this retrospective study. The primary outcome was to compare the transplant-free survival among SV (total plasma volume x 1) and HV (total plasma volume x 1.5) PLEX groups at 30-days. Secondary objectives were to compare the effect of SV and HV PLEX on total bilirubin, INR, ammonia levels, SOFA, and MELD Na scores, and the adverse events related to PLEX. Results: A total of 17 patients underwent PLEX(SV-8 and HV-9).The mean age and severity scores (SOFA-4.13 ±1.72 in SV group vs. 4.89±1.7 in HV group; P=0.37) were similar among both the groups. Most common cause of ALF was viral in each group. Fifty percent in SV and 34% in HV group satisfied King’s College Criteria for liver transplantation(P=0.41). Each patient in both the groups underwent a median of 2 sessions of PLEX. Post-PLEX, the change in total bilirubin, INR, ammonia, SOFA, and MELD Na score was comparable. Mortality at seven days was similar among both groups (SV-12.5% vs. 33.3% in HV; P=0.57). Mortality at day 30 was 25% in SV compared to 67% in the HV group (P=0.1). On Kaplan Meier analysis, transplant-free survival at day 30 was similar in both the groups (P=0.26). Two patients in the HV group developed volume overload features and were managed conservatively compared to none in the single volume group. Conclusions: Standard volume plasma exchange has similar efficacy as high volume plasma exchange on severity scores. Standard volume plasma exchange is safe and effective for patients with acute liver failure.

Associação de exames hematológicos e bioquímicos e complicações pós-cirurgia cardiovascular

Cardiac surgery has postoperative complications of varying severities. Knowing the predictors of such complications can minimize risks and increase patient survival. However, studies address postoperative complications without any standardization of predictors of such complications. The objective of this study was to evaluate the association of hematological and biochemical parameters in the pre- and postoperative period with general clinical complications and those according to organ affected in the postoperative period of cardiac surgery. This is a cross-sectional, retrospective, analytical and documentary study. Inclusion criteria: Elective myocardial revascularization surgeries and/or valve replacements with a cardiopulmonary bypass from January to December 2017, in patients older than 18 years old, survivors until hospital discharge. Incomplete medical records were excluded. Ethical research precepts were followed. 194 patients were included. Preoperative leukocyte alterations increased the chance of postoperative complications by 8.24 times (p=0.039); high mean INR values in the first postoperative period were associated with complications (p=0.036); changes in creatinine (p=0.020) and INR (p=0.002) in the first and second postoperative period were associated with complications, in addition to changes in hemoglobin associated with cardiac complications on the third postoperative day (p≤0.001). There was an association between: leukocyte alteration prior to surgery and total postoperative complications; postoperative hematological and biochemical changes and complications in general and by affected organ. These results can support the development of risk indicators. This also indicates the need to improve monitoring of leukocyte levels, INR, hemoglobin, and creatinine, perceived as predictors of surgical complications.

Prothrombin Complex Concentrate Use in Intracranial Hemorrhage Patients With Cirrhosis Not on Prior Anticoagulation.

Patients with intracranial hemorrhage (ICH) have a 30-day mortality rate up to 52%, and the risk of mortality is increased in patients with disease-induced coagulopathy such as cirrhosis. The objective of this study was to evaluate whether 4F-PCC administration mitigates hematoma expansion in ICH patients with cirrhosis not currently receiving anticoagulation therapy compared to standard of care therapies. This was a single-center, retrospective study comparing adult patients with ICH and history of cirrhosis who received 4F-PCC versus standard of care therapies. The primary outcome was rate of ICH expansion within 24 hours after admission. A total of 58 patients were included with 21 who received 4FPCC vs 37 who received standard of care therapies. The 4F-PCC group had a significantly higher number of patients with Child Pugh Class C cirrhosis (85.7% vs. 48.6%, P = 0.006), higher baseline INR (1.7 vs. 1.4, P = 0.001) and more patients with a spontaneous cause of hemorrhage (61.9% vs. 29.7%, P = 0.01). Stable follow-up head CT was achieved in 68.4% of patients who received 4F-PCC versus 72.7% of patients treated with standard of care therapies (P = 0.11). Patients who received 4F-PCC had a significantly greater change in INR within 24 hours (-0.2 vs. 0, P = 0.02) and higher rate of mortality (61.9% vs. 18.9%, P = 0.001). Baseline INR > 2 and surgical evacuation for ICH were associated with decreased odds of stable follow-up head CT in the multivariate logistic regression model. A single dose of 4F-PCC did not significantly improve the rate of stable head CT at 24 hours in patients with ICH and cirrhosis. Randomized clinical trials with larger patient populations are warranted to fully determine the role of 4F-PCC in this unique population.

Impact of Obesity on Warfarin Reversal With Fixed-Dose Factor VIII Inhibitor Bypassing Activity (aPCC).

Data are limited addressing anticoagulant reversal in obese patients using activated prothrombin complex concentrate (aPCC). Assess the impact of obesity on INR reversal with fixed aPCC dosing. Institutional review board-approved, retrospective cohort conducted in a large academic medical center. Patients 18 years or older who received fixed-dose aPCC for warfarin-associated hemorrhage were included. Patients who received aPCC for any other indications or who had no follow-up INR after aPCC administration were excluded. Patients with an INR of 5 or greater received 1000 units aPCC, whereas those with INR less than 5 received 500 units aPCC, per institutional protocol. Patients were stratified into obese and nonobese based on body mass index. Primary end point was INR reversal, defined as repeat INR of 1.4 or less within 4 hours following aPCC treatment, without a repeated dose. Secondary end points included percentage change in INR, proportion of patients requiring an additional dose of aPCC, bleeding complications, thrombotic complications, hospital length of stay, and in-hospital mortality. 259 patients were included, of whom 83 were obese (32%). A significantly higher proportion of nonobese patients achieved an INR of 1.4 or less within 4 hours of treatment (169 [96.02%] vs 69 [83.13%]; P = 0.0004). There were no differences in any secondary end points. When fixed-dose aPCC is used for warfarin reversal, obesity is associated with a significantly lower rate of INR reversal, without increased bleeding. This study adds to the limited amount of literature on aPCC dosing in obesity.

Alteration in prothrombin time, INR, partial thromboplastin time and platelets in type 2 diabetes mellitus, cross-sectional study- Sudan

Diabetes mellitus is a common disease and it is a major cause of morbidity; several studies indicate that diabetes is a likely under reported cause of death. The goal of current study to evaluate the alteration of Prothrombin Time,Activated Partial Thromboplastin Time and Thrombocytes among in type 2 diabetes mellitus. Fifty-seven patients have diabetic and twenty healthy people considered as control. The blood coagulation parameters (PT, INR and aPTT) were measured by coagulation analyzer. Platelets was counted by hematological analyzer (Sysmex). Data analysis was performed using statistical package for social science (SPSS) software. Evaluation of patient’s data was performed using the t-test and Pearson correlation test, results with p value < 0.05 were considered as statistically significant. Our result showed with p value < 0.05 in PT, INR, aPTT and Platelet, when were compared to control group. From our finding we concluded that, diabetes mellitus is more prone to change in PT, INR, APTT and Platelet count.

Evaluation of a Fixed, Low-Dose Four-Factor Prothrombin Complex Concentrate Dosing Protocol for International Normalized Ratio Reversal at Two Academic Medical Centers

Background: Emerging data suggest fixed four-factor prothrombin complex concentrate (4F-PCC) dosing may adequately reverse warfarin, minimize time to INR reversal, and reduce medication costs. A 4F-PCC fixed-dosing strategy for INR reversal was implemented at The Johns Hopkins Hospital and Johns Hopkins Bayview Medical Center. We describe the outcomes associated with implementation of this dosing protocol, and compare outcomes among patients receiving two 4F-PCC fixed-dosing strategies. Methods: According to the 4F-PCC fixed-dosing protocol, patients with warfarin-induced intracranial hemorrhage (ICH) with actual body weight &gt; 50 kg received Kcentra® 1,500 units once, while patients &lt; 50 kg received Kcentra® 1,000 units once. Regardless of the initial dose, all warfarin-induced ICH patients with inadequate INR reversal after initial dosing qualified for repeat dosing with Kcentra® 500-1,000 units if clinically indicated. Patients requiring INR reversal for non-ICH indications received Kcentra® 1,000 units once, with a repeat dose of Kcentra® 1,000 units administered for inadequate INR reversal if clinically indicated. Patients who received 4F-PCC fixed-dosing from January 18, 2019 to June 18, 2019 were included. Patients who received Kcentra® doses &gt; 1,700 units due to protocol non-adherence were excluded. Patients were included in the efficacy analysis if they had a baseline INR &gt; 1.4 and a post-Kcentra® administration INR result was available. All patients receiving fixed 4F-PCC during this time period were included in the cost savings analysis, regardless of baseline INR. Results: A total of 51 patients received 52 administrations of fixed-dose Kcentra® during the study period. Six patients received FDA-approved Kcentra® dosing, and were excluded. Kcentra® 1,000 units was administered for non-ICH INR reversal indications in 25 (48%) cases. Kcentra® 1,500 units was administered for INR reversal in the setting of warfarin-induced ICH in 19 (36.5%) cases. Fixed Kcentra® dosing deviated from our institutional dosing protocol in eight of 52 cases. The most common indications for Kcentra® administration were ICH (36.5%), refractory hemorrhage after cardiac surgery (17%), gastrointestinal bleeding (11.5%), and emergent procedure or surgery (7.7%). For patients in the efficacy analysis (n=39), the median baseline INR was 2.8 (IQR 1.95-4.1), the median time to INR measurement after Kcentra® administration was 83 minutes (IQR 40-173), and the median weight was 70.3 kg (IQR 61.8-92.2). Thirty-two patients (82.1%) in the efficacy analysis received an intravenous dose of vitamin K 10 mg in addition to Kcentra®, and two patients received an intravenous dose of vitamin K 5 mg. The change in INR before and after Kcentra® administration is shown in Figure 1. Thirty-seven (94.8%) patients included in the efficacy analysis achieved an INR measurement &lt; 2 following Kcentra® administration. Twenty-eight (71.7%) of patients included in the efficacy analysis achieved an INR of &lt; 1.7 following Kcentra® administration. One patient required repeat Kcentra® dosing. When comparing patients who received Kcentra® 1,000 units to 1,500 units, there was no significant difference in achievement of INR values &lt; 2.0 (94.4% vs. 95.2%, p=0.72) or &lt; 1.7 (66.7% vs. 76.2%, p=0.51). Additionally, there was no significant difference in achievement rates of INR values &lt; 1.7 in those with baseline INRs &gt; 4.0 in the Kcentra® 1,000 unit group compared to 1,500 units (66.7% vs. 40%, p=0.392). Utilizing the actual wholesale price of 2.90 USD per unit, the estimated cost savings from use of Kcentra® fixed-dosing was 148,348 USD. Conclusions: Administration of Kcentra® 1,000 to 1,500 units effectively reduced the baseline INR to &lt; 2 in 94% of cases. There were no significant differences in achievement of post-treatment INR values of &lt;2.0 or &lt; 1.7 between those who received Kcentra® 1,000 units versus 1,500 units. Achievement rates of INRs &lt; 1.7 after Kcentra® administration in patients with significantly elevated baseline INRs (INR &gt; 4) were also not significantly different between treatment groups. However, these findings must be confirmed in larger studies due to the small sample size in this analysis. Additionally, implementation of a 4F-PCC fixed-dosing protocol is associated with significant cost savings. Disclosures Shanbhag: Daiichi Sankyo/Lultpold Pharmaceuticals: Research Funding. Streiff:Pfizer: Consultancy, Honoraria; Bayer: Consultancy, Honoraria; Portola: Consultancy, Honoraria; Roche: Research Funding; Daiichi-Sankyo: Consultancy, Honoraria; Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding. OffLabel Disclosure: Kcentra: used in some patients in our cohort for reversal of non-warfarin-associated INR elevation

03:09 PM Abstract No. 113 Lobar Yttrium-90 transarterial radioembolization equal or greater than 150Gy MIRD: an analysis of hepatic biochemical safety as a function of treated liver volume and administered dose

Yttrium-90 transarterial radioembolization (TARE) is a safe procedure for the treatment of primary and metastatic hepatic malignancies. There is a strong suggestion that increased administered dose correlates with tumor response. While segmental TARE can preserve hepatic parenchyma, selective administrations are not always possible. Existing literature supports a Medical Internal Radiation Dose (MIRD) of 150Gy to a hepatic lobe using glass microspheres. The safety of doses >150Gy is not as well understood. The hepatic biochemical safety of lobar TARE at MIRD ≥150Gy was evaluated. Patients who underwent lobar TARE with glass microspheres for the treatment of liver malignancies at a MIRD of ≥150Gy with appropriate follow up at two academic centers from 2014 to 2018 were included. Multivariate linear regression models were used to evaluate differences in hepatic biochemical function and clinical scoring models at baseline and at 1 and 3 months following TARE as function of percent liver treated and dose. The occurrence of adverse events (CTCAE criteria) was also recorded. 23 patients were included in the study. 20 patients had primary hepatic malignancies (13 HCC and 7 ICC), and 3 had metastatic disease. 21 patients were Child Pugh (CP) A. Right lobar TARE was performed in 12 patients and left lobar TARE in 11 patients. The mean dose and target liver volume percentage was 234Gy (range 150-463) and 44% (range 13-75), respectively. Overall, there was no statistically significant change in sodium, INR, creatinine, albumin, Na-MELD, ALBI, or CP score at 1 and 3 months post TARE with doses ≥ 150Gy. The mean increase in Na-MELD was 4 (p=.005) and bilirubin was 0.4 (p=.04) at 1 month for patients receiving 200Gy demonstrated a mean increase in Na-MELD of 0.6 (p=.005) and bilirubin of 0.01 (p=.04). These correlations were not statistically significant at 3 months (also observed in the HCC cohort). There were 2 grade III CTCAE complications (pain and diarrhea). Lobar TARE with ≥150Gy MIRD using glass microspheres is not significantly associated with hepatic biochemical change in patients with preserved liver function at 3 months post treatment.

Reducing Unnecessary Coagulation Testing in Outpatients (REDUCTION): A Quality Improvement Project

Introduction: The prothrombin time (PT) and partial thromboplastin time (PTT) are often considered ‘routine’ tests in the outpatient setting. They are frequently used as screening tests for bleeding disorders in unselected patients despite sensitivities ranging of 1-2 %. For the most common bleeding disorder, a negative score on a bleeding assessment tool (BAT), in the presence of a negative family history, has a NPV of 1. A recent quality improvement study conducted in the emergency department at our institution resulted in a greater than 2-fold reduction in coagulation test ordering rates and more than $6000 CAN direct cost-savings per month.Objectives: We developed a multimodal sequential quality improvement study in the outpatient family practice unit with the primary aim of minimizing unnecessary coagulation testing and maximizing the appropriate use of a BAT.Materials and Methods: We have developed four interventions using plan-do-study-act (PDSA) cycles to achieve our goal. Cycle (1) baseline assessment of ordering rates, involved stakeholder engagement, development of educational tools and addition of the BAT onto the electronic medical record (EMR). Cycle (2) involved assessment of EMR-available BAT. Cycle (3) involved an audit to determine appropriateness of coagulation testing for patients on oral anticoagulants and a subsequent targeted intervention. Cycle (4) involved alteration of the laboratory requisition and facilitating access to decision support and educational materials. Rates were calculated per 100 patient visits per month. Data were analyzed on Strata 13 using an interrupted time series analysis.Results: After Cycle 1, we saw a significant decrease in rates of PT and PTT ordering from 1.9 tests per 100 patient visits per month (for both tests) to 1.5 and 1.4 respectively; (p< 0.001 for both). However, the rate of creatinine (control) testing rate also decreased significantly (8.9 to 8; p=0.006). With Cycle 2, we found that all referrals for bleeding from the family practice unit were appropriate and only 19% of patients who had a BAT completed were referred. In Cycle 3, we identified an inappropriate PT and PTT ordering rate of 11% and 36% respectively for patients on oral anticoagulants. We also identified that PT and PTT were being tested together despite being ordered individually; further investigation revealed that they were being erroneously coupled by laboratory technicians. Finally, results of Cycle 4 showed no significant change in INR (increase by 0.05; p=0.64) or PTT (increase by 0.01; p=0.95) testing rates but a significant increase in control testing rates (0.68; p=0.016) in the first 4 months after the intervention.Conclusions: From our previous quality improvement project in the emergency department, we learned that educational interventions alone are often not sufficient and that a process change is required to achieve meaningful change in coagulation test utilization. Through EMR integration of the BAT we successfully guided hematology referrals for bleeding. We were unable to alter rates of PTT testing despite physically removing the PTT from the lab requisition. This likely reflects the strength of the cultural link between INR and PTT. Planning is underway for PDSA Cycle 5 which will consist of a lab audit of PTT testing and subsequent targeted intervention. DisclosuresJames:Shire: Research Funding; Bayer: Research Funding; CSL Behring: Research Funding.

Child-Pugh Score Predicts Mortality Better than Model of End Stage Liver Disease: A Study in a Tertiary Care Hospital in the Periphery of Karachi

Objective: To observe the scores of the model of end-stage liver diseaseand Child-Pugh (CP) scores on hospital admission in patients of cirrhosis.&#x0D; Methods: A cross-sectional study, in 6 months from September 17th to March 18th, using non-probabil- ity convenience sampling was conducted, in which we inducted 165 patients with diagnosed cirrhotic liver disease in aninpatient department. We noted the demographics and staged the patient for chronic liver disease according to Child-Turcotte-Pugh classification using ascites, encephalopathy, prothrombin time, serum albumin and serum bilirubin levels and compared it with MELD (Model for End-Stage Liver Disease) score using serum bilirubin, creatinine and change in INR. We predicted the outcome of patient according to both scores.&#x0D; Results: Out of 165 patients, 127 (76.96%, 84 males and 43 females) patients improved, while 38 (23.04%, 29 males and 9 females) patients expired. Correlation of CP and MELD scores was done by Pearson's bivariate correlation test and it gave the correlation coefficient of 0.626 with highly signifi- cant value of p&lt;0.0001. The area under curve (AUC) was slightly more for CP (0.961) as compared to MELD (0.911).&#x0D; Conclusion: The MELD score compared to the CP score does not appear to offer a clear advantage in predicting mortality in patients with decompensated cirrhosis, but comparatively CP score per- formed better than the MELD with significantly higher AUC.

Changes in International Normalized Ratios After Plasma Transfusion of Varying Doses in Unique Clinical Environments.

Plasma transfusion is commonly performed for the correction of abnormal coagulation screening tests. The goal of this investigation was to assess the relationship between the dose of plasma administered and changes in coagulation test results in a large and diverse cohort of patients with varying levels of coagulation abnormalities and comorbid disease and in a variety of clinical settings. In this single-center historical cohort study, all plasma transfusion episodes in adult patients with abnormal coagulation screening tests were extracted between 2011 and 2015. The primary outcome was the proportion of patients attaining normal posttransfusion international normalized ratio (INR ≤ 1.1) with secondary outcomes including the proportion of patients attaining partial normalization of INR (INR ≤ 1.5) or at least 50% normalization in pretransfusion values with respect to an INR of 1.1. In total, 6779 unique patients received plasma with a median (quartiles) pretransfusion INR of 1.9 (1.6-2.5) and a median transfusion volume of 2 (2-3) units. The majority (85%) of transfusions occurred perioperatively, with 20% of transfusions administered prophylactically before a procedure. The median decrease in INR was 0.4 (0.2-0.8). Complete INR normalization was obtained in 12%. Reductions in INR were modest with pretransfusion INR values <3. Patients receiving ≥3 units of plasma were more likely to achieve at least 50% normalization in INR than those receiving ≤2 units (68% vs 60%; P < .001). Changes in INR after plasma transfusion were modest at typically used clinical doses, particularly in those with less severely deranged baseline coagulation screening tests. Further studies are necessary to assess the relationships between plasma-mediated changes in INR and clinical outcomes.

Four factor prothrombin complex concentrate for warfarin reversal in patients with left ventricular assist devices.

Continuous flow left ventricular assist devices (CF-LVAD) require therapeutic anticoagulation which is often interrupted for procedures or bleeding. Prior to the availability of four factor prothrombin complex concentrate (4F-PCC) in the United States, warfarin was held and its effects reversed by vitamin K or fresh frozen plasma. We evaluated the use of 4F-PCC for temporary warfarin reversal in patients with CF-LVADs and assessed outcomes. This analysis is a retrospective study of CF-LVAD patients who received 4F-PCC for warfarin reversal in the setting of bleeding or need for urgent or elective procedures. Primary outcome assessments included feasibility of administration in elective versus emergent situations, safety measured as incidence of thrombotic events, and change in INR after administration. In total, 37 CF-LVAD patients received 49 4F-PCC administrations. The average 4F-PCC dose was 1842 units (range 518-4292 units), or 22 units/kg (range 5.8-58 units/kg). 4F-PCC significantly decreased the mean INR from 2.9 to 1.7 (p < 0.0001) in 47 of 49 administrations; two patients did not have post infusion INR testing. No cases of new confirmed or suspected pump thrombosis, stroke, venous thromboembolism, arterial thrombosis, or myocardial infarction were observed within 30 days of administration of 4F-PCC. 4F-PCC administration for temporary warfarin reversal was demonstrated to be feasible, effective, and, safe in CF-LVAD patients and judged to be 96% effective in patients for whom data were available. We observed no thrombotic events attributed to use of 4F-PCC.

Therapeutic Effect of the Combination of Xiaoaiping Injection and Chemotherapy on Advanced Esophageal Cancer and Coagulation Function

Objective To observe the therapeutic effect of the combination of Xiaoaiping injection and chemotherapy on advanced esophageal cancer and coagulation function. Methods 100 patients with advanced esophageal carcer were randomly divided into control group and observation group, and each group had 50 cases. The control group was treated with TP chemotherapy, and the observation group, on the basis of the control group’s treatment, was treated with the Xiaoaiping injection, and treatment effects, Karnofsky, adverse drug reactions and INR changes before and after the treatment of the two groups were observed. Results After 2 periods of treatment, the local control rate of solid tumor, Karnofsky score, and stability in the observation group were significantly higher than those in the control group (p&lt;0.05); and the plasma prothrombin time (PT), activated partial coagulation activity time (APTT) and thrombin time (TT) were significantly lower in the observation group than in the control group (p&lt;0.05), and Fibrinogen (FIB) was significantly higher than the control group (p&lt;0.05); and there was no statistically significant difference in the incidence of adverse reactions between the two groups (p&gt;0.05). Conclusion: The therapeutic effect of the combination of Xiaoaiping Injection and chemotherapy on advanced esophageal cancer is obvious, and it can effectively improve the coagulation function, improve the quality of life, and be safe and reliable, so it's worth popularizing and application.

ACCP Virtual Poster Symposium

<scp>ACCP</scp> Virtual Poster Symposium

Therapeutic Role of Punica Granatum (Pomegranate) Seed Oil Extract on Bone Turnover and Resorption Induced in Ovariectomized Rats.

Postmenopausal osteoporosis is mostly caused by increased bone remodeling resulting from estrogen deficiency. Hormone replacement therapy (HRT) is used to prevent osteoporosis, but it increases the risk for breast cancer, thromboembolism, strokes, and heart attacks. Pomegranate seed oil extract (SOE) is rich in phytoestrogen and antioxidant compounds. To evaluate the therapeutic role of SOE against bone turnover, resorption and osteoporosis induced in ovariectomized rats as a postmenopausal model and comparing the results with those from Generic CycloProgynova drug (D). The study used western albino rats undergo bilaterally ovariectomization as a model for postmenopausal. The study took part in a laboratory setting. Forty female western albino rats (age: 3-4 months) weighing 150-180 gm. Rats were divided into four groups, 10 rats each; SC-group: Sham control = untreated and unovariectomized rats; OVX-group = ovariectomized rats; (OVX-SOE) and (OVX-D) groups = OVX rats were treated with SOE and D, respectively. Bone markers (BMs) especially osteocalcin (BGP), alkaline phosphatase (ALP), tartarate resistance acid phosphatase (TRAcP), bone weight, bone calcium concentration, serum electrolytes (calcium, sodium and potassium) and serum estradiol (E2) level and histopathological examination of bones were determined. Also lipid profile, uric acid, prothrombin time (INR) and liver and kidney functions were measured to evaluate the adverse effects of SOE and D. In OVX group the activities of ALP and TRAcP and the levels of BGP, serum calcium, sodium and body weight were significantly higher (p≤0.05) than SC-group, while bone calcium concentration, bone mass, serum E2 and potassium level as well as uterus mass were significantly lower (p≤0.05). Also histopathological results revealed that the outer cortical bone became thinner, while the cancellous bone trabeculae lost their normal architecture. Moreover in OVX group lipid profile and uric acid levels were significantly higher (p≤0.05) than SC group, but there were no significant changes (p≤0.05) in INR level, liver and kidney functions. Treatment of OVX rats with SOE or D for 12 weeks improved both the architecture of bones as shown from the histopathological results and BMs, serum electrolytes and E2 levels (p≤0.05) which approached SC-group. Moreover after treatment of OVX rats with SOE the levels of lipid profile and uric acid were improved and approached SC-group, while liver function became significant lower (p≤0.05) than SC-group. Also there were no significant changes (p≤0.05) in kidney functions and INR of (OVX-SOE), OVX and SC groups. In contrast in (OVX-D) group the levels of lipid profile, liver and kidney functions, uric acid and INR were significantly higher (p≤0.05) than those of OVX and SC groups. The results of this study show that SOE has therapeutic effects on osteoporosis, while it has no adverse effects on lipid profile, uric acid, liver and kidney functions when compared to HRT. SOE offers a promising alternative in the design of new strategies in nutritional management of age-related bone complications.

Implications of an inpatient warfarin dosing nomogram on safety outcomes post-discharge.

Many hospitals have implemented warfarin dosing nomograms to improve patient safety. To our knowledge, no study has assessed the impact inpatient warfarin initiation has in both medical and surgical patients, on safety outcomes post discharge. To evaluate the impact of a suggested institutional nomogram for the initiation of warfarin, the primary endpoint was the incidence of bleeding throughout follow up. Secondary endpoints included the composite of INR changes ≥0.5/day and INR >4. Patients were followed for a period of 2weeks post-discharge. The composite endpoint was evaluated for an effect on reaching therapeutic INR, time to reach therapeutic INR, and bleeding events throughout follow up. A single center retrospective study comparing the safety of adherence vs. non-adherence to a warfarin nomogram. A total of 206 patients were included, 73 patients in the nomogram adherence vs. 133 in the nonadherence arm. There was no difference in the proportion of patients who bled throughout the follow up period, adherence 9.6% vs. nonadherence to the nomogram 13.5%, p = 0.407. There was however a statistical difference in the mean total number of bleeding events, 0.096 (7/73) in the adherence vs. 0.158 (21/133) in the non-adherence arm, p = 0.022. There was also no difference in the composite endpoint, 19.2% in the adherence vs. 28.6% in the non-adherence arm p = 0.180. A positive correlation between the inpatient composite and risk of bleeding throughout follow up was noted. The findings of this study support adherence to the nomogram as opposed to non-adherence.

Interaction Between Dietary Vitamin K Intake and Anticoagulation by Vitamin K Antagonists: Is It Really True?: A Systematic Review.

Educational advice is often given to patients starting treatment with vitamin K Antagonists (VKAs). A great emphasis is made on nutritional information. Common belief is that dietary vitamin K intake could counteract the anticoagulant effect by VKAs and for many years, patients have been discouraged to consume vitamin-K-rich foods, such as green leafy vegetables.The objective of this study is to summarize the current evidence supporting the putative interaction between dietary vitamin K intake and changes in INR with the VKAs.Data sources are MEDLINE via PubMed and Cochrane database.All clinical studies investigating the relationship between dietary vitamin K and measures of anticoagulation were included. We excluded all studies of supplementation of vitamin K alone.We performed a systematic review of the literature up to October 2015, searching for a combination of “food,” “diet,” “vitamin K,” “phylloquinone,” “warfarin,” “INR,” “coagulation,” and “anticoagulant.”Two dietary interventional trials and 9 observational studies were included. We found conflicting evidence on the effect of dietary intake of vitamin K on coagulation response. Some studies found a negative correlation between vitamin K intake and INR changes, while others suggested that a minimum amount of vitamin K is required to maintain an adequate anticoagulation. Median dietary intake of vitamin K1 ranged from 76 to 217 μg/day among studies, and an effect on coagulation may be detected only for high amount of vitamin intake (>150 μg/day).Most studies included patients with various indications for VKAs therapy, such as atrial fibrillation, prosthetic heart valves, and venous thromboembolism. Thus, INR target was dishomogeneous and no subanalyses for specific populations or different anticoagulants were conducted. Measures used to evaluate anticoagulation stability were variable.The available evidence does not support current advice to modify dietary habits when starting therapy with VKAs. Restriction of dietary vitamin K intake does not seem to be a valid strategy to improve anticoagulation quality with VKAs. It would be, perhaps, more relevant to maintain stable dietary habit, avoiding wide changes in the intake of vitamin K.