Fresh Frozen Plasma In Patients Research Articles

Cryoprecipitate-Poor Plasma Instead of Fresh Frozen Plasma As Replacement Therapy in Thrombotic Thrombocytopenic Purpura: A Systematic Review and Meta-Analysis

Background: Thrombotic thrombocytopenic purpura (TTP) is a life-threatening condition characterized by the presence of small-vessel thrombi enriched with platelets, leading to thrombocytopenia, thrombotic microangiopathy (TMA), and on occasion, resulting in end-organ damage. The standard therapeutic plasma exchange (TPE) approach, initiated after suspicion of TTP, is done with fresh frozen plasma (FFP). Yet, the use of cryoprecipitate-poor plasma (CPP) has been suggested as alternative in recent decades given its absence of von Willebrand factor, which would benefit the pathophysiology of TTP. However, its efficacy over FFP remains unclear. Therefore, we aimed to conduct a meta-analysis to compare the safety and efficacy of CPP versus FFP in patients with TTP. Methods: We systematically searched PubMed, Cochrane Central and Embase for clinical studies published up to June 2023, comparing CPP to FFP as replacement fluids in TPP or TMA patients. Outcomes assessed were overall mortality, relapse rate, response to treatment and number of TPE sessions. We pooled outcomes as odds ratios (OR) and mean differences (MD) with 95% confidence intervals (CI). We also performed a subgroup analysis with randomized controlled trials (RCTs). Statistical analysis was performed with Review Manager version 5.4.1. Heterogeneity was assessed with I 2 statistics. The protocol was registered in PROSPERO (ID: CRD42023440665). Results: A total of eight articles met inclusion criteria, of which three were RCTs. The combined dataset involved 290 patients, of which 144 (49.7%) were in CPP group and 146 (50.3%) in the FFP group. CPP significantly reduced overall mortality compared to FFP (OR 0.27; 95% CI 0.13-0.59; p=0.001; I 2=0%; Figure 1A). However, our subgroup analysis of RCTs showed no significant difference in overall mortality between groups (OR 0.49; 95% CI 0.13-1.84; p=0.29; I 2=0%; Figure 1B). Additionally, there were no significant differences between groups regarding relapses (OR 0.81; 95% CI 0.37-1.77; p=0.60; I 2=0%; Figure 1C), response to treatment (OR 2.20; 95% CI 0.69-7.07; p=0.18; I 2=44%; Figure 1D) or number of TPE sessions (MD 1.63; 95% CI -2.83 - 6.08; p=0.47; I 2=55%; Figure 1E). Conclusion: Our meta-analysis shows that the safety and efficacy of CPP in TTP patients is at least similar to FFP in reducing mortality, relapse rate, and improving response to treatment. The reduced mortality with CPP found in the whole pool of studies, along with the trend towards reduced mortality found in the RCT-only analysis indicates the potential benefit of CPP over FFP. However, larger population-based randomized trials should contribute to narrow confidence intervals and decrease bias of observational studies, providing clearer conclusions for treatment efficacy in the future.

Efficacy of Prothrombin Complex Concentrate versus Fresh Frozen Plasma in Patients with Bleeding in the Emergency Department

Efficacy of Prothrombin Complex Concentrate versus Fresh Frozen Plasma in Patients with Bleeding in the Emergency Department

The Prognostic Role of In-Hospital Transfusion of Fresh Frozen Plasma in Patients with Cholangiocarcinoma Undergoing Curative-Intent Liver Surgery

Introduction: Major hepatectomy for perihilar and intrahepatic cholangiocarcinoma (CCA) is often associated with a significant intraoperative blood loss and the requirement for perioperative transfusion of blood products. The aim of this study was to investigate the oncological impact of fresh frozen plasma (FFP) transfusion during hospitalization in patients undergoing hepatectomy for CCA as adverse effects have been described in other malignancies.

Prognostic Value of Antithrombin Levels in COVID-19 Patients and Impact of Fresh Frozen Plasma Treatment: A Retrospective Study

Objective:The defective interplay between coagulation and inflammation may be the leading cause of intravascular coagulation and organ dysfunction in coronavirus disease-19 (COVID-19) patients. Abnormal coagulation profiles were reported to be associated with poor outcomes. In this study, we assessed the prognostic values of antithrombin (AT) activity levels and the impact of fresh frozen plasma (FFP) treatment on outcome.Materials and Methods:Conventional coagulation parameters as well as AT activity levels and outcomes of 104 consecutive critically ill acute respiratory distress syndrome (ARDS) patients with laboratory-confirmed COVID-19 disease were retrospectively analyzed. Patients with AT activity below 75% were treated with FFP. Maximum AT activity levels achieved in those patients were recorded.Results:AT activity levels at admission were significantly lower in nonsurvivors than survivors (73% vs. 81%). The cutoff level for admission AT activity was 79% and 58% was the lowest AT for survival. The outcome in those patients who had AT activity levels above 75% after FFP treatment was better than that of the nonresponding group. As well as AT, admission values of D-dimer, C-reactive protein, and procalcitonin were coagulation and inflammatory parameters among the mortality risk factors.Conclusion:AT activity could be used as a prognostic marker for survival and organ failure in COVID-19-associated ARDS patients. AT supplementation therapy with FFP in patients with COVID-19-induced hypercoagulopathy may improve thrombosis prophylaxis and thus have an impact on survival.

A pragmatic pilot phase II randomised controlled trial of prothrombin complex concentrates (PCC) versus fresh frozen plasma (FFP) in adult patients who are undergoing heart surgery (PROPHESY)

BackgroundFresh frozen plasma (FFP) is the accepted standard treatment for clotting factor replacement in bleeding patients during or immediately after cardiac surgery. In the United Kingdom prothrombin complex concentrate (PCC) is not licensed in this setting, although it is being used in Europe because it has a higher concentration of clotting factor levels, and it can be administered rapidly and in small volume, resulting in less volume overload during cardiac surgery.MethodsPROPHESY is a pragmatic, single-centre, open-label, randomised, controlled pilot trial that will assess whether it is feasible to perform a large trial in the future that will compare PCC versus FFP in patients who are bleeding (not on warfarin) and who require blood transfusion. Over a 15-month period, 50 patients will be randomised to PCC versus FFP if they develop active bleeding within 24 h of cardiac surgery and for whom the clinician has decided to administer FFP for treatment of bleeding. Standard laboratory and point-of-care assessments will be performed as per routine practice, and additional research blood samples will be taken at three time points to assess haemostasis. Subjects will be assessed daily up to hospital discharge or 30 days or death (whichever occurs first) and will be seen in follow-up for 90 days after surgery to assess for thromboembolic complications and hospital re-admission since discharge. Quality-of-life assessment will be performed pre-surgery and at 90 days post-surgery. We will also perform qualitative research with clinical experts and patients to explore the understanding of and experience with the interventions, as well as adherence to study procedures and protocol.DiscussionThere have been no randomised controlled trials that have compared the safety and efficacy of FFP versus PCC in cardiac surgery patients who are bleeding. This pilot study will assess if individual components of a large trial are deliverable to assess the safety and efficacy of the two blood products in the future.Trial registrationEudraCT, 2018-003041-41; ClinicalTrials.gov, NCT03715348. Registered on 29 July 2018.

European Stroke Organisation Guideline on Reversal of Oral Anticoagulants in Acute Intracerebral Haemorrhage

The aim of the present European Stroke Organisation guideline document is to provide clinically useful evidence-based recommendation on reversal of anticoagulant activity VKA (warfarin, phenprocoumon and acenocoumarol), direct factor II (thrombin) inhibitors (dabigatran etexilat) and factor-Xa-inhibitors (apixaban, edoxaban and rivaroxaban) in patients with acute intracerebral haemorrhage. The guideline was prepared following the Standard Operational Procedure for a European Stroke Organisation guideline document and according to GRADE methodology. As a basic principle, we defined use of oral anticoagulation pragmatically: oral anticoagulation use is assumed by positive medical history unless relevant anticoagulant activity is regarded unlikely by medical history or has been ruled out by laboratory testing. Overall, we strongly recommend using prothrombin complex over no treatment and fresh-frozen plasma in patients on VKA plus vitamin K. We further strongly recommend using idarucizumab in patients on dabigatran and make a recommendation for andexanet alfa in patients on rivaroxaban and apixaban over no treatment. We make a weak recommendation on using high-dose prothrombin complex concentrate (50 IU/kg) for all patients taking edoxaban and for patients on rivaroxaban or apixaban in case andexanet alfa is not available. We recommend against using tranexamic acid and rFVIIa, outside of trials. The presented treatment recommendations aim to normalise coagulation, there is no or only indirect data on effects on functional outcome or mortality, and only little data from randomised controlled trials.

Activated prothrombin complex concentrate for warfarin reversal in traumatic intracranial hemorrhage

BackgroundPatients with traumatic intracranial hemorrhage (TIH) anticoagulated with warfarin are at an increased risk of mortality. Fresh frozen plasma (FFP) and vitamin K have been the standard treatment for warfarin reversal; however, guidelines now recommend the use of prothrombin complex concentrate (PCC) for warfarin reversal in patients with life-threatening bleeding. Our protocol uses one vial (∼1000 units) of activated PCC (aPCC) for warfarin reversal, regardless of the weight or presenting international normalized ratio (INR). The purpose of this study was to determine the safety and efficacy of using fixed, low-dose aPCC for warfarin reversal in patients with TIH. MethodsThis was a retrospective chart review that included patients with an Abbreviated Injury Scale Head score of ≥3, TIH, and initial INR ≥ 1.5 on warfarin. Patients aged <18 years and those with no repeat INR were excluded. The primary outcome was to compare the percentage of patients with INR ≤ 1.4 after receiving aPCC versus FFP within 24 hours. ResultsEighty-nine patients were in the FFP group and 31 patients in the aPCC group. The INR was reversed more effectively in the aPCC group compared with the FFP group (90.3% versus 69.7%, P = 0.029). The median time (hours) to reversal was also significantly shorter in the aPCC group compared with the FFP group (3.75 versus 6.75, P = 0.003). However, there was no difference in mortality (35.5% aPCC versus 22.2% control, P = 0.162) or incidences of thrombosis. ConclusionFixed, low-dose aPCC is safe and more effective at reversing the effects of warfarin than FFP in patients with TIH.

Efficacy and Safety of Prothrombin Complex Concentrate in Patients Undergoing Major Cardiac Surgery

IntroductionAdministration of coagulation factors after major cardiac surgery, with or without cardiopulmonary bypass, may be a strategy for reducing risk of bleeding and requirement for allogeneic blood transfusions. However, transfusion of large volumes of fresh frozen plasma (FFP) is restricted by the competing problem of heart failure, a common complication following cardiac surgery in patients with existing cardiac decompensation. Prothrombin complex concentrate (PCC) has a smaller volume of administration than FFP for a similar amount of coagulation factors, making it an attractive option in this situation. However, patients undergoing complex cardiac surgery may also have prothrombotic conditions and have a high risk of both venous and arterial thrombosis including ischemic neurological complications. We performed a retrospective analysis to investigate whether the use of PCC is safe and effective compared with FFP to treat coagulopathy in patients undergoing isolated coronary artery bypass graft (CABG), valve surgery (with or without concomitant CABG) and major aortic procedures. If the patient was on warfarin, this was stopped at least 5 days before the surgery and appropriate bridging was followed. For patients on dual antiplatelet therapy, P2Y12 receptor inhibitors such as Clopidogrel and Prasugrel were stopped 5-7days before the surgery and Aspirin was allowed to continue. The decision to use PPC or FFP was based on individual patient characteristics such as complexity of the surgery and previous history of increased bleeding during surgery and also ability to tolerate volume.MethodsOne hundred and seventy consecutive adult patients who underwent major cardiac surgery between January 2015 and December 2015 were studied. Among them, 87 received PCC (male/female = 55/32, mean age= 56 years) and 83 received FFP (male/female = 56/27, mean age = 58 years) to control coagulopathy. The decision on need for coagulation factor treatment and the choice of treatment was made by the treating team of the patient. Those who received both PCC and FFP were excluded. Blood loss within first 12 hours and 24hours from the end of operation, total use of allogeneic blood and platelet transfusion and patient outcomes in terms of thrombotic complications both venous and arterial, incidence of acute kidney injury and 30 day mortality were compared in the two groups. Antiplatelet drug effect on bleeding was also assessed.ResultsThere was no significant difference in the amount of bleeding at the first 12 hours from the end of the operation in the two groups (p=0.25) :median and 95% confidence interval [CI] were 825mL [926-1317] and 787mL [804-1067] patients received PPC or FFP respectively. However, total blood loss within 24hours was significantly higher in patients who received PPC (median [CI] (1575mL [1658-2263]) compared to FFP (median [CI] (1213mL [1244-1641]), P=0.0034. There was no difference in the mean blood loss between patients continued Aspirin at the time of surgery and those who were not on Aspirin in either groups. The use of allogeneic blood (P=.001) and platelets (P=0.03) was significantly higher in patients receiving FFP compared to PPC. A significantly higher number of patients treated with FFP (9.6% vs 3.5%, p=0.002) developed cardiac failure related to circulatory overload. There was no difference in thrombotic events in the two groups: one patient from each group (1.1%) developed venous and arterial thrombosis respectively following surgery. Thirty day mortality rate was similar in the patients receiving FFP or PPC (4%) and none were directly related to surgery. There was no difference in the acute kidney injury in the two groups.ConclusionsThis retrospective analysis suggests that PCC may be an alternative to FFP in patients undergoing major cardiac surgery. Although there was a higher amount of bleeding within 24hours of surgery in patients treated with PCC, this may reflect the complexity, duration and the individual patient risk of bleeding due to selection bias. The use of PPC may reduce the number of allogeneic blood and platelet transfusion in these patients and reduce risk of circulatory overload. There was no increased risk of thrombosis with use of PCC. However, randomized controlled studies powered to evaluate efficacy and safety in patients receiving PCC versus FFP for coagulopathic bleeding after major cardiac surgery are warranted. DisclosuresLaffan:CSL: Other: Travel support; Octapharma: Speakers Bureau.

Tracheostomy in intensive care unit patients can be performed without bleeding complications in case of normal thromboelastometry results (EXTEM CT) despite increased PT-INR: a prospective pilot study.

BackgroundCoagulopathy is often accompanied by prolongation of prothrombin time (PT) in septic and nonseptic patients in intensive care unit (ICU). The conventional way to correct the coagulopathy is to administer fresh frozen plasma (FFP) before invasive procedures to minimise the risk of bleeding. However, prolonged PT can be present even in hypercoagulation status, resulting in unnecessary administration of FFP. In the present study, we have assessed the reliability of thromboelastometry in case of prolonged PT and the relationship to bleeding complications during surgical tracheostomy.MethodsThe study was conducted during the period between April 2013 and April 2014 in patients undergoing surgical tracheostomy. Coagulation status was assessed using PT, and the status was reassessed by thromboelastometry for prolonged PT. Tracheostomy was performed in patients with normal thromboelastometry results without administering FFP.ResultsTracheostomy was performed in total 119 patients. Normal value of PT as measured by international normalized ratio (INR) ≤ 1.2 was found in 64 (54 %) patients, while prolonged INR > 1.2 was found in 55 (46 %) patients. Patients with INR ≥ 1.3 (with INR min- 1.3, max- 1.84, and median- 1.48) were further analysed by thromboelastometry. Despite prolonged INR, thromboelastometry results were in normal ranges in all cases except one. With normal thromboelastometry, tracheostomy was performed safely without any bleeding complication.ConclusionsSurgical tracheostomy in septic and nonseptic patients can be performed without bleeding complications in case of normal thromboelastometry results (EXTEM CT) despite increased PT-INR. This method can help physicians to reduce unnecessary administration of FFP in patients.

Prophylactic Use of Fresh Frozen Plasma in Patients Undergoing Liver Resection: Does it Make any Sense?

Background: The use of fresh frozen plasma in liver resection has recently been questioned due to the lack of supportive evidence. The aim of the study was to evaluate the clinical impact of a transfusion protocol implemented in our Institution based on the avoidance of prophylactic use of plasma. Methods: 172 adult undergone liver resection were analyzed retrospectively: 104 (study group) underwent surgery between 1/1/2012 and 06/30/2013 and 68 during 2009 (historic group). Prior to the implementation of this protocol in 2009, the prophylactic administration of plasma was a practice in cirrhotic and non-cirrhotic patients when major liver resection was performed. Results: Clinical characteristics, indication and type of resection were similar in both groups. The median of blood loss during surgery was similar. The new protocol induced a significant decrease in the intraoperative use of plasma and red blood cells: none of patients in the study group received plasma whereas 50% of patients in the historic group received a mean of 1000 ml of plasma and the rate of red blood cells transfusion went from 18% to 6% of patients. The overall in-hospital major complication rate was similar. In the historic group the rate of re-intervention was significantly higher (9 vs. 3%, p=0.01) the median in-hospital stay (10 vs. 7, p<0.05). There were no differences in the postoperative residual liver function. Conclusion: In liver resections, the avoidance of routine administration of FFP was not associated to an increase of neither perioperative bleeding nor postoperative complications nor worse liver function.

Coagulation challenges after severe injury with hemorrhagic shock

During the past 50 years, there have been huge changes in the approach to coagulopathic bleeding following the treatment of traumatic hemorrhagic shock (HS). Treatment during the 1960s consisted primarily of physiologic saline (balanced electrolyte solution [BES]) and whole blood supported with sodium bicarbonate for acidosis. Subsequent coagulopathy was assumed to be caused by lack of the labile factors (FV and FVIII) which were then replaced by fresh whole blood. The decade of 1970s saw the implementation of component therapy by the American Blood Banking Association so that HS was treated with BES and packed red blood cells (RBC). A new paradigm had to be learned to determine when and how much fresh frozen plasma (FFP) was needed to restore all coagulation factors. By the end of 1970s, most trauma centers were supplementing BES and RBC with FFP in patients with severe injuries requiring massive transfusion of more than one circulating blood volume. By the 1980s, the use of FFP skyrocketed, creating a crisis for the American Blood Banking Association. This led to a National Institute of Health Consensus Development Conference which concluded that FFP should be given to only those patients who had a documented coagulopathy as evidenced by a prolongation of the prothrombin time and the partial thromboplastin time. Restriction of FFP replacement to patients with proven coagulopathy after treatment for HS led to postoperative bleeding which was sometimes fatal. During the 1990s, uncontrolled clinical studies and rigorously controlled animal studies showed that FFP should be administered before the onset of proven coagulopathy with prolongation of the prothrombin time and partial thromboplastin time. Later during the 1990s, recombinant-activated factor VII (FVIIa) was purported to provide quicker hemostasis in patients treated with HS. The efficacy of FVIIa supplementation is still being assessed. During the 2010s, the military surgeons promoted the use of a hemostatic regimen which consists of platelets, RBC, and FFP in a 1:1:1 ratio. This recommendation is still being assessed with different authors reporting benefits and detriments. Throughout these years, an unusual entity of disseminated intravascular coagulation (DIC) was known to complicate the resuscitation of seriously injured patients with HS. This syndrome was typically seen after treatment of HS and was associated with abnormal bleeding plus respiratory failure and renal failure thought to be caused by a combination of micro- and macrothromboses. The early studies suggested that the best therapy for breaking this viscous cycle of bleeding and intravascular coagulation was by infusing fresh whole blood. The theoretical benefits of administering heparin to prevent the thrombosis and epsilon-aminocaproic acid to enhance lysis have not proven beneficial. DIC is also seen in association with toxic exposures, including snake bites. Epsilon-aminocaproic acid may be beneficial in that setting. Many of the intricate understandings of DIC remain elusive and are still being studied.

Prothrombin complex concentrate (Octaplex)

In emergency/clinical practice it is often necessary to restore the balance of blood coagulation: the rapid reversal of oral anticoagulant therapy (OAT) is crucial in cases of serious acute bleeding and emergency surgery in patients with high international normalized ratios (INRs). Coagulation can be normalized via the application of haemostatic products, including fresh frozen plasma (FFP) or prothrombin complex concentrates (PCCs). Guidelines recommend PCCs for the reversal of OAT in preference to FFP in patients with major/life-threatening bleeding and high INRs. Advantages of PCCs include: minimal disruption to haemostasis, rapid administration and fast onset of action. One such PCC is Octaplex which is available in many countries, including Portugal. The aim of this retrospective, observational, multicentre study was to assess the clinical applications and efficacy (via reduction in INR after treatment) of Octaplex. Over the 4-year study period, 1194 infusions of Octaplex were administered in 1152 patients (69.2% for reversal of OAT, 17.3% for liver dysfunction, 10.2% for uncontrolled bleeding). The mean patient age was 64 years and the mean dose of Octaplex was 20.37 ± 7.00 IU/kg. Overall, Octaplex treatment was associated with a significant reduction in INR (P < 0.0001). In 95% of all treatment episodes, only one dose of Octaplex was required. No adverse drug reactions or thromboembolic events were reported. Octaplex effectively and significantly reduces INR values in patients requiring the restoration of blood coagulation. It effectively reverses the effect of OAT and was efficacious in the majority of bleeding episodes in patients with liver dysfunction.

Evaluation of fresh frozen plasma usage at a medical college hospital - A two year study

Aims: The aim of this is study was to evaluate the usage of fresh frozen plasma (FFP) according to indications and to reduce inappropriate usage. Methods: A two year retrospective study was conducted in Medical College Hospital blood bank. Based on the guidelines published by College of American Pathologists, National Health and Medical Research Council and Australasian Society for Blood Transfusion FFP usage were categorized into appropriate and inappropriate. Pre and post-transfusion INR/PT were recorded and the effect of FFP were studied in patients who received FFP. Results: During two years 1884 units of FFP were used for 945 patients. Only 454 (48%) requests were appropriate and 491 (52%) were inappropriate requests. Absence of bleeding or surgical intervention was the commonest reasons for inappropriate FFP use. Mean improvement in the pre-transfusion INR per unit of FFP was 0.75 (median 0.56, range 0–3.7) of which 33% showed significant improvement in the pre-transfusion INR. Conclusions: Our results showed a 48% appropriate and 52% inappropriate use of FFP in patients. Inappropriate FFP use could be reduced by educating the staff, by establishing the hospital transfusion guidelines, by regular evaluation of requistions and by conducting awareness programme among clinicians.

Peroperative effects of fresh frozen plasma and antithrombin III on heparin sensitivity and coagulation during nitroglycerine infusion in coronary artery bypass surgery

Nitroglycerin (NTG) reduces the anticoagulant effects of heparin and may lead to heparin resistance. Fresh frozen plasma (FFP) and antithrombin III (ATIII) may be used for the treatment of heparin resistance. We aimed to compare the effects of FFP and ATIII on heparin requirement, coagulation parameters, and bleeding in patients undergoing coronary artery bypass graft surgery (CABGS) with moderate dose of intraoperative NTG infusion. Forty-eight patients undergoing CABGS with NTG infusion were randomly allocated to three groups. Group C served as control, whereas the patients in group P received FFP and those in group A received ATIII after anesthesia induction. ATIII activity and coagulation parameters were measured at five different times intraoperatively. Total heparin requirement, heparin consumption, and heparin sensitivity were calculated. ATIII activity and ACT were significantly higher and activated partial thromboplastin time and fibrinogen level were significantly lower during cardiopulmonary bypass in group A than in groups P and C. Heparin sensitivity was significantly higher and total heparin requirement and consumption were significantly lower in ATIII group than in other groups. ATIII administration increases heparin sensitivity and decreases heparin requirements compared with FFP in patients undergoing CABGS with peroperative NTG infusion. ATIII may be preferred to FFP in patients with heparin resistance due to NTG infusion undergoing CABGS.

Prothrombin Complex Concentrate for Critical Bleeding

To review the evidence supporting the use of prothrombin complex concentrate (PCC) as a hemostatic agent in individuals without hemophilia. Articles were identified through a search of Ovid/MEDLINE (up to April 2011) and Cochrane Central Register of Controlled Trials (up to April 2011). The search terms used were prothrombin complex concentrate, hemorrhage, and bleeding. The search was limited to comparative studies. Bibliographies of retrieved articles were reviewed to obtain additional articles. The intent of the search was to identify original research comparing PCC to fresh frozen plasma (FFP) or recombinant factor VIIa for the management of bleeding in patients without hemophilia. PCCs are recommended as an alternative to FFP and recombinant factor VIIa for the treatment of serious or life-threatening bleeding related to vitamin K antagonist therapy. Studies in this setting have shown that PCCs are safe and effective and provide prompt reduction of international normalized ratio (INR) compared to FFP. However, most trials are uncontrolled, and the primary outcomes in these studies have been INR reduction rather than hemostatic effect. Other common off-label uses include coagulopathy due to hepatic failure and traumatic hemorrhage; however, there is insufficient evidence to support use of PCC in these settings. Advantages of PCC include the low drug volume required compared to FFP. The use of PCC may be associated with thromboembolic complications. PCC is a safe and effective alternative to FFP and provides rapid reversal of INR in patients on vitamin K antagonist therapy. These agents may be advantageous compared to FFP in patients with volume restrictions. Comparative trials are needed to compare the various PCC products, FPP, and recombinant factor VIIa with regard to clinically significant outcomes such as hemostatic effect.

Fresh frozen plasma (FFP) use during massive blood transfusion in trauma resuscitation

Introduction Recent retrospective studies have found high fresh frozen plasma (FFP) to packed red blood cell (PRBC) ratios during trauma resuscitation to be associated with improved mortality. Whilst this association may be related to a mortality bias present in these studies, there has been an overall tendency towards a 1:1 FFP:PRBC ratio in massive transfusion guidelines worldwide. The aim of this study was to retrospectively review the administration of FFP in patients undergoing massive transfusion during trauma resuscitation, to add to the evidence base for massive transfusion guidelines. Materials and methods Multi-trauma patients who were administered blood transfusions of 5 units or more of packed red blood cells (PRBCs) in the first 4 h were included in this study. Mortality was the primary endpoint with length of hospital stay, ICU hours and mechanically ventilated hours secondary endpoints. Results There were 331 patients included in this study with a median Injury Severity Score (ISS) of 36 (25–50) and a mortality of 29.9%. There was little change in the ratio of FFP:PRBC transfused per patient from 2005 to 2008. A low FFP:PRBC ratio in the first 4 h of resuscitation, older age, low initial GCS and coagulopathy on presentation were significant independent factors associated with mortality. When deaths in the first 24 h were excluded, the FFP:PRBC ratio had no association with mortality. Discussion This study has shown increased initial survival in association with higher FFP:PRBC ratios during massive transfusion in a population with a high proportion of blunt injuries. The association is difficult to interpret because of an inherent survival bias. The optimal ratio of FFP:PRBC during massive transfusion may be different to 1:1 and further prospective research is required. There is now an increasing need for well designed randomised controlled trials to determine the best FFP:PRBC ratio for the resuscitation of blunt multi-trauma patients.

The effect of fresh frozen plasma in severe closed head injury

Objective Traumatic brain injury (TBI) is one of the most common causes of morbidity and mortality. Coagulopathy, commonly occurring after severe TBI, is associated with poor outcome and secondary complications, especially delayed traumatic intracerebral hematoma (DTICH). In this study we evaluated the effect of fresh frozen plasma (FFP) on the reduction in the incidence of DTICH in severe closed head injury victims. Methods This study was carried out as a double-blind randomized clinical trial. Ninety patients were entered in two parallel groups taking either FFP or normal saline (N/S). Patients’ selection criteria for both groups were: severe closed head injury (Glasgow coma scale ≤8), no mass lesion required evacuation and no history of coagulopathy. The clinical findings, laboratory data, computed tomography (CT) scans and Glasgow outcome scale after 1 month were assessed and compared in two groups. Results Out of 90 patients, 44 received FFP and 46 received N/S. The development of new intracerebral hematoma in follow-up CT scans were more common in the FFP group than the N/S group ( p = 0.012). Both groups showed similar frequency of poor outcome ( p = 0.343). The mortality was significantly more common in the FFP group than in the N/S group (63% versus 35%, p = 0.006). Conclusion The result of this study revealed that early empirical infusion of FFP in patients with severe head injury may lead to adverse effects, such as an increase in the frequency of DTICH and an increase in the mortality.

Prothrombin complex concentrate versus fresh frozen plasma in patients on oral anticoagulant therapy undergoing cardiac surgery: a randomized study

To reverse oral anticoagulant (OAC) therapy, a number of treatment modalities is available. Fresh frozen plasma (FFP) is effective and is currently used for coagulation factor replacement, carrying a risk of volume overload, transmission of infective agents and being time consuming. Variable and frequently low potency of clotting factors results in minor haemostatic effects compared with prothrombin complex concentrates (PCC), which are considered very effective and safe. PCC PPSB-SD® has constant, highly concentrated levels of factors II, VII, IX and X compared with FFP. We studied the efficacy of the intraoperative administration of PCC and FFP in patients on OAC therapy undergoing heart surgery with cardiopulmonary bypass (CPB).

内科疾患における新鮮凍結血しょうとアルブミン製剤の適正使用に関する研究

We evaluated the appropriateness of usage of fresh frozen plasma (FFP) and albumin for patients in internal medicine in seven general of Tokyo Metropolitan hospitals according to blood usage guidelines revised in 1999. We investigated patients with hepatoma or disseminated intravascular coagulation (DIC) in 1999, and all patients in internal medicine except for those undergoing plasma exchange in 2000.The total number of patients entered in the study for FFP and albumin was 279 and 250, respectively. FFP transfusion was judged appropriate when used in patients whose prothrombin time (PT) was 30% or less. Albumin administration was judged appropriate if used for patients with hypoalbuminemia below 3.0g/dL and with circulation failure, or in patients with hypoalbuminemia below 2.5g/dL without circulation failure. We judged the usage of FFP or albumin to be inappropriate if the PT value of patients for FFP or serum albumin value of patients for albumin was not measured before usage. Appropriate usage rate of FFP in patients with hepatoma or DIC was 16.2% in 1999 and 20.8% in 2000. In contrast, the appropriate usage rate of albumin from 1999 to 2000 was 65.2%.This study will help in assessing the degree of publicity received by the blood usage guidelines and the future direction of this publicity.

Evaluation of Solvent/Detergent-Treated Plasma in Patients with a Prolonged Prothrombin Time

Objectives: To compare the laboratory and clinical outcome of patients who received solvent/detergent-treated plasma (SDP) and fresh-frozen plasma (FFP). Methods: A randomized, double-blinded study to assess the ability of SDP and FFP to reduce a prolonged prothrombin time (PT) to ≤15 s in patients with acquired coagulation deficits. Results: 45 patients (22 SDP vs. 23 FFP) were treated with 71 infusions. There were no significant differences in mean dose of plasma infused (7.8 ml/kg for SDP vs. 8.0 ml/kg for FFP, p = 0.46), percentage of patients who corrected their PT to ≤15 s (32% for SDP vs. 26% for FFP, p = 0.67), or percentage of patients whose bleeding ceased (27% for SDP vs. 22% for FFP). Conclusion: No clinical or statistically significant differences were observed after infusion with SDP or FFP in patients with acquired coagulation deficits.