Transfusion Of Allogeneic Blood Products Research Articles

Effect of Autotransfusion Using Intraoperative Predonated Autologous Blood on Coagulopathy during Thoracic Aortic Surgery: A Randomized Controlled Trial.

Background: Intraoperative predonated autologous blood transfusion is thought to replenish platelets and coagulation factors and ameliorate coagulopathy. This study aimed to evaluate whether intraoperative predonated autotransfusion improves coagulopathy during thoracic aortic surgery.Methods: Patients who underwent thoracic aortic surgery were randomized into two groups as follows: those who received intraoperative predonated blood (group A: n = 31) and those who did not receive (group N: n = 22). In group A, autologous blood was retransfused immediately after cessation of cardiopulmonary bypass (c-CPB).Results: The mean intraoperative allogenic blood or blood product transfusion requirements were significantly lesser in group A than in group N (packed red blood cells [RBCs]: 6.3 ± 5.1 vs. 9.1 ± 4.3 units, p = 0.04; fresh frozen plasma [FFP]: 3.0 ± 4.1 vs. 6.1 ± 5.7 units, p = 0.03). After c-CPB, hemoglobin (Hb) level, platelet count, and coagulopathy became significantly worse than those at the start of surgery in both the groups. However, the values significantly improved 30 min after c-CPB only in group A. Renal function was significantly worse in group N.Conclusions: Intraoperative predonated autotransfusion significantly improved coagulopathy, with reduced allogeneic blood transfusion volume during thoracic aortic surgery. Furthermore, reduction of allogeneic blood transfusion may reduce the adverse effects on renal function.

Evaluation of risk scores in predicting perioperative blood transfusions in adult cardiac surgery.

Objective:Allogeneic blood product transfusions are associated with an increased morbidity and mortality risk in cardiac surgery. At present, a few transfusion risk scores have been proposed for cardiac surgery patients. The present study is aimed to develop a new score and to compare with preexisting scores – Transfusion Risk and Clinical Knowledge (TRACK) and Transfusion Risk Understanding Scoring Tool (TRUST) score.Methodology:A total of 1014 adult patients undergoing cardiac surgery were enrolled in the retrospective study. Independent predictors of allogeneic blood transfusions were selected from TRACK and TRUST scores. A predictive score was developed from six variables using logistic regression analysis, and new score was compared to the other existing scores – TRACK and TRUST.Results:The new score had following predictors: age >58 years, weight <63 kg for males and <49 kg for females, gender (female), complex surgery, hemoglobin <13.5 g/dl, and creatinine >1.36 mg/dl. Validation of new score demonstrated an acceptable predictive power (area under the curve [AUC] 0.749) and a good calibration at the Hosmer–Lemeshow test. New score was comparable with TRACK score with P = 0.578 (AUC of TRACK 0.756 and AUC of new score 0.749). There was a significant difference between new score and TRUST score, P = 0.01 (AUC of TRUST 0.72 and AUC of new score 0.749).Conclusion:New score is a simple risk model based on six predictors having a similar accuracy and calibration in predicting the transfusion rate in cardiac surgery as compared to TRACK score.

OC13 COMPARING SPRAYABLE HEMOSTAT/SEALANT ADJUNCT TO TRADITIONAL HEMOSTASIS AFTER CARDIAC REDO SURGERY: A RANDOMIZED SUTDY

Abstract Background: Bleeding after cardiac surgery is a common, unresolved, and consequence-heavy. Despite meticulous hemostasis, some degree of diffuse bleeding (referred to microvascular bleeding) tends to persist at surgery completion. Several techniques to reduce post-operative bleeding have been attempted. We have utilized a thin sprayable layer of a hemostat/sealant (Tisseel, Baxter Healthcare, Deerfield, Illinois) to reduce post-operative blood loss This study (NCT02360800) compared the effectiveness of adjunct hemostat/sealant, applied via a compressed air spray, in sealing the microvascular bed prior to chest closure in cardiac redo surgery Methods: All patients undergoing any type of cardiac redo surgery between March 2015 to October 2017 were enrolled and allocated in a 1:3 ratio to adjunct hemostat/sealant spray or control (defined as no specific treatment for microvascular bleeding) A 1:2 best-neighbor propensity matching technique was then applied to obtain a matched cohort. Primary analyses: Post-operative bleeding at 3, 6, 9, 12 and 24 hours post-surgery Secondary analyses: allogeneic blood product transfusion during 4 post-operative days. Results: The study included 71 participants (17 adjunct hemostat/sealant; 54 control/no specific treatment) Of these, 54 propensity-matched subjects (17 adjunct hemostat/sealant; 34 control/no specific treatment) were analysed Hemostat/sealant use resulted in significantly lower post-operative blood loss at the 3, 6, 9, and 12 hour timepoints Significantly lower amounts of blood products were transfused to the matched and unmatched hemostat/sealant vs. control cohort participants Conclusion: In patients undergoing cardiac redo surgery, adjunct hemostat/sealant spray use was associated with less post-operative blood loss and lower blood product transfusion utilization.

Fibrinogen Concentrate in Cardiovascular Surgery: A Meta-analysis of Randomized Controlled Trials.

Postoperative bleeding remains a frequent complication after cardiovascular surgery and may contribute to serious morbidity and mortality. Observational studies have suggested a relationship between low endogenous plasma fibrinogen concentration and increased risk of postoperative blood loss in cardiac surgery. Although the transfusion of fibrinogen concentrate has been increasing, potential benefits and risks associated with perioperative fibrinogen supplementation in cardiovascular surgery are not fully understood. PubMed, Cochrane Library, Ovid MEDLINE, Embase, Web of Science, and China National Knowledge Infrastructure were searched on January 15, 2017, with automated updates searched until February 15, 2018, to identify all randomized controlled trials (RCTs) of fibrinogen concentrate, whether for prophylaxis or treatment of bleeding, in adults undergoing cardiovascular surgery. All RCTs comparing fibrinogen infusion versus any other comparator (placebo/standard of care or another active comparator) in adult cardiovascular surgery and reporting at least 1 predefined clinical outcome were included. The random-effects model was used to calculate risk ratios and weighted mean differences (95% confidence interval [CI]) for dichotomous and continuous variables, respectively. Subgroup analyses by fibrinogen dose and by baseline risk for bleeding were preplanned. A total of 8 RCTs of fibrinogen concentrate in adults (n = 597) of mixed risk or high risk undergoing cardiovascular surgery were included. Compared to placebo or inactive control, perioperative fibrinogen concentrate did not significantly impact risk of all-cause mortality (risk ratio, 0.41; 95% CI, 0.12-1.38; I = 10%; P = .15). Fibrinogen significantly reduced incidence of allogeneic red blood cell transfusion (risk ratio, 0.64; 95% CI, 0.49-0.83; I = 0%; P = .001). No significant differences were found for other clinical outcomes. Subgroup analyses were unremarkable when analyzed according to fibrinogen dose, time of infusion initiation, mean cardiopulmonary bypass time, and rotational thromboelastometry/fibrinogen temogram use (all P values for subgroup interaction were nonsignificant). Current evidence remains insufficient to support or refute routine perioperative administration of fibrinogen concentrate in patients undergoing cardiovascular surgery. Fibrinogen concentrate may reduce the need for additional allogeneic blood product transfusion in cardiovascular surgery patients at high risk or with evidence of bleeding. However, no definitive advantage was found for reduction in risk of mortality or other clinically relevant outcomes. The small number of clinical events within existing randomized trials suggests that further well-designed studies of adequate power and duration to measure all-cause mortality, stroke, myocardial infarction, reoperation, and thromboembolic events should be conducted. Future studies should also address cost-effectiveness relative to standard of care.

Feasibility of autologous intraoperative blood collection and retransfusion in small children with complex congenital heart defects undergoing cardiopulmonary bypass.

Allogeneic blood product transfusion is common in pediatric patients undergoing cardiopulmonary bypass although it is associated with an increased risk for adverse events. Furthermore, numerous donor exposures may affect future blood transfusion needs and human leukocyte antigen matching for patients who may ultimately require cardiac transplantation. Autologous intraoperative blood collection and retransfusion is a known method of blood preservation, but has not been extensively practiced in pediatric patients. In this study we assess the feasibility of this blood conservation technique in small children with complex congenital heart defects undergoing cardiopulmonary bypass. After Institutional Review Board approval, we retrospectively reviewed the medical records of children weighing <10kg who underwent cardiopulmonary bypass over a 2-year period. Eighteen patients underwent autologous intraoperative blood collection and retransfusion and comprised the study group. Eighteen control patients were chosen by a 1:1 matched design using preoperative hematocrit, surgical procedure, and body weight. Multiple corresponding demographic and surgical variables, transfusion data, and clinical outcomes were compared. Patient demographics, operative parameters and preoperative laboratory, and coagulation values were similar between the two groups. Despite the removal of autologous blood, study patients did not require more inotropic support prior to cardiopulmonary bypass. They also did not experience a significant increase in bleeding as measured by 24-hour postoperative chest tube output. Study patients were exposed to significantly fewer donor units intraoperatively and within the first 24hours postoperatively. The use of autologous intraoperative blood collection and retransfusion is a feasible option for small children with complex congenital heart defects undergoing cardiopulmonary bypass. Study patients received significantly fewer donor exposures without an increase in postoperative bleeding. Children who require multiple cardiac surgeries or eventually transplantation could benefit from this blood conservation technique.

Evaluation of the real-world impact of rotational thromboelastometry-guided transfusion protocol in patients undergoing proximal aortic surgery

BackgroundComplex aortic procedures are potentially associated with important blood loss and coagulopathy. The aim of this study was to assess the impact of rotational thromboelastometry (ROTEM, Tem International GmBH, Munich, Germany) on transfusion requirements after proximal aortic operations in a real-world setting. MethodsThis single-center retrospective analysis based on 385 consecutive patients undergoing cardiac surgeries involving the aortic root, ascending aorta, or aortic arch compared 197 controls managed according to routine transfusion protocol before the introduction of the ROTEM in 2012 with 188 patients operated afterward. With the use of a 1:1 propensity score match, 224 patients were included in paired analysis (112 in each group). The primary end point was erythrocytes transfusion rate. The secondary end points comprised the transfusion of other allogeneic blood products, number of units transfused, postoperative blood loss, massive transfusion rate, and use of other hemostatic products. ResultsROTEM implementation was associated with a trend toward reduction in the rate of erythrocytes transfusion (57% vs 46%, P = .08) and a decreased median number of units transfused for erythrocytes (1.0 [0.0-4.0] unit vs 0.0 [0.0-2.0] unit, P = .03) and plasma (0.0 [0.0-4.0] unit vs 0.0 [0.0-2.0] unit, P = .04). After sensitivity analysis, ROTEM displayed a comparable rate of erythrocytes transfusion (58% vs 47%, P = .15). ConclusionsIn a real-world setting, ROTEM-based algorithm implementation could help reduce excess erythrocytes transfusion for complex aortic procedures. We advocate for a strict adherence and concerted team effort to maximize the benefits of such addition to patients' management.

Point-of-Care Testing in Trauma Patients - Methods and Evidence

In severely injured patients, trauma-induced coagulopathy (TIC) present at hospital admission is associated with increased transfusion requirements, morbidity and mortality. Early and effective treatment contributes to improved survival rates. Laboratory coagulation assays have long turn-around times and evidence for their usefulness, especially in the context of TIC, is weak. Due to the lack of appropriate guidance, transfusion of allogeneic blood products frequently follows a ratio-based concept (e.g., transfusion of erythrocytes and plasma in a 1 : 1 ratio). Point-of-care (PoC) tests enable the assessment of prothrombin time (PT) and activated partial thromboplastin time in few minutes. However, although normal PT in these tests allows to rule out relevant effects of several anticoagulants, they are not able to detect patients with TIC and/or requiring subsequent massive transfusion. Viscoelastic tests (VETs) make it possible to assess defects in thrombin generation, hypofibrinogenaemia, thrombocytopenia, and hyperfibrinolysis, and thus enable targeted therapy. Impairment of platelet function is the common blind spot not detectable using both standard laboratory-based tests and VETs. However, PoC platelet function tests enable to detect platelet defects and patients taking anti-platelet. Furthermore, impaired platelet function has been identified as a strong predictor for coagulopathy and massive transfusion in trauma patients. In other clinical settings, coagulation management based on VETs is associated with decreased transfusion requirements, incidence of acute kidney failure, and mortality, respectively. Data of the first small prospective randomised trial indicate superiority of VET guided coagulation management solely using coagulation factor concentrates, when compared to plasma transfusions in severe trauma.

Thromboelastometry profile in critically ill patients: A single-center, retrospective, observational study.

BackgroundTransfusion therapy is associated with increased morbidity, mortality and costs. Conventional coagulation tests (CCT) are weak bleeding predictors, poorly reflecting coagulation in vivo. Thromboelastometry (ROTEM) provides early identification of coagulation disorders and can guide transfusion therapy by goals, reducing blood components transfusion.ObjectiveThe aim of this study is to describe coagulation profile of critically ill patients using ROTEM and evaluate the association between CCT and thromboelastometry.MethodsThis is a retrospective, observational study conducted in medical-surgical intensive care unit (ICU). Adult patients (≥18 years) admitted to ICU between November 2012 and December 2014, in whom ROTEM analyses were performed for bleeding management were included in this study. The first ROTEM and CCT after ICU admission were recorded simultaneously. Additionally, we collected data on blood components transfusion and hemostatic agents immediately after laboratory tests results.ResultsThe study included 531 patients. Most ROTEM tests showed normal coagulation profile [INTEM (54.8%), EXTEM (54.1%) and FIBTEM (53.3%)] with divergent results in relation to CCT: low platelet count (51.8% in INTEM and 55.9% in EXTEM); prolonged aPTT (69.9% in INTEM and 63.7% in EXTEM) and higher INR (23.8% in INTEM and 27.4% in EXTEM). However 16,7% of patients with normocoagulability in ROTEM received platelet concentrates and 10% fresh frozen plasma.ConclusionThe predominant ROTEM profile observed in this sample of critically ill patients was normal. In contrast, CCT suggested coagulopathy leading to a possibly unnecessary allogenic blood component transfusion. ROTEM test may avoid inappropriate allogeneic blood products transfusion in these patients.

Type II Minimal‐Invasive Extracorporeal Circuit for Aortic Valve Replacement: A Randomized Controlled Trial

Extracorporeal circulation triggers systemic inflammatory response and coagulation disorders which may lead to unfavorable clinical outcome. A type II minimally-invasive extracorporeal circuit (MiECC) is a closed system with markedly reduced artificial surface as compared to conventional extracorporeal circuits (CECC). The aim of this study was to investigate and compare inflammatory responses, complement activation and selected clinical end-points in isolated surgical aortic valve replacement (SAVR) performed with a type II MiECC circuit or a CECC. Fifty patients were prospectively randomized to MiECC or CECC perfusion regimen. Complement activation (sC5b-9), inflammation (IL-6, TNF-α, sCD40-ligand) and activation of the coagulation system (D-dimer, TAT-complex) were determined before operation, at 2 hours and 24 hours after surgery. Clinical end-points included perfusion time, transfusion of allogeneic blood products, postoperative bleeding, sepsis, new onset of atrial fibrillation, stroke and in-hospital mortality. Patient characteristics and baseline plasma markers were similar in both groups. Levels for sC5b-9, TNF-α, sCD40 ligand, TAT-complex and D-dimers were not significantly different between MiECC and CECC at 2 hours and 24 hours after surgery. The IL-6 plasma concentration was lower in the CECC group at 24 hours (P = 0.026, vs. MiECC). Comparisons of the baseline level to values at 2 hours and 24 hours, adjusted for the type of oxygenator and hemoglobin, showed a significantly lower sC5b-9 in MiECC at 2 hours (P = 0.013), but no difference at 24 hours (P=0.990). Compared with CECC, MiECC patients had a shorter perfusion time (P = 0.037) and less transfusion requirements (P = 0.04). In this selected cohort of SAVR patients, the type II MiECC was not inferior to CECC in terms of inflammatory response and complement activation. Thus, MiECC might be an alternative perfusion strategy to conventional.

The Coagulation Profile of End-Stage Liver Disease and Considerations for Intraoperative Management.

The coagulopathy of end-stage liver disease results from a complex derangement in both anticoagulant and procoagulant processes. With even minor insults, cirrhotic patients experience either inappropriate bleeding or clotting, or even both simultaneously. The various phases of liver transplantation along with fluid and blood product administration may contribute to additional disturbances in coagulation. Thus, anesthetic management of patients undergoing liver transplantation to improve hemostasis and avoid inappropriate thrombosis in the perioperative environment can be challenging. To add to this challenge, traditional laboratory tests of coagulation are difficult to interpret in patients with end-stage liver disease. Viscoelastic coagulation tests such as thromboelastography (Haemonetics Corporation, Braintree, MA) and rotational thromboelastometry (TEM International, Munich, Germany) have helped to reduce transfusion of allogeneic blood products, especially fresh frozen plasma, but have also lead to the increased use of fibrinogen-containing products. In general, advancements in surgical techniques and anesthetic management have led to significant reduction in blood transfusion requirements during liver transplantation. Targeted transfusion protocols and pharmacologic prevention of fibrinolysis may further aid in the management of the complex coagulopathy of end-stage liver disease.

A Low-dose human fibrinogen is not effective in decreasing postoperative bleeding and transfusion requirements during cardiac surgery in case of concomitant clinical bleeding and low FIBTEM values: A retrospective matched study.

Background:Studies evaluating the hemostatic effects of fibrinogen administration in cardiac surgery are not conclusive.Aims:We investigated whether the use of a low-dose human fibrinogen in case of clinical bleeding after protamine administration and concomitant low FIBTEM values is effective in reducing postoperative bleeding. Secondary end-point was to investigate the consumption of allogeneic blood products.Setting and Design:This was a retrospective matched study conducted at university hospital.Materials and Methods:Among 2257 patients undergoing surgery with cardiopulmonary (CPB) bypass, 73 patients received a median dose of 1 g human fibrinogen (ROTEM-Fibri group). This group was matched with 73 patients who had not received human fibrinogen (control group) among 390 patients having undergone surgery at the moment FIBTEM analysis was unavailable.Statistical Analysis:Matching was performed for the type and the presence of redo surgery. McNemar and Wilcoxon paired tests were used to respectively compare the categorical and quantitative variables.Results:The CPB bypass time was significantly higher in the ROTEM-Fibri group (P = 0.006). This group showed significantly higher bleeding in the first 12 and 24 h postoperatively (P < 0.001) and required significantly more transfusion of blood products (P < 0.001) and surgical revision (P = 0.007) when compared with the control group. There was no significant difference in the number of thromboembolic complications.Conclusions:These results show that the administration of 1 g of fibrinogen based on low-FIBTEM values and clinical bleeding after protamine administration does not stop bleeding and the need for transfusion of allogeneic blood products.

Calibrated automated thrombogram values in infants with cardiac surgery before and after cardiopulmonary bypass

IntroductionImpaired thrombin generation has been associated to increase bleeding after cardiac surgery with cardiopulmonary bypass (CPB), especially in children. The aim of this study was to evaluate standard coagulation assay, thrombin generation by calibrated automated thrombogram (CAT), thromboelastography (TEG) and procoagulant phospholipids (PPL) activity in infants undergoing cardiac surgery with CPB. Materials and methodsProspective observational study performed in children aged <24months undergoing cardiac surgery with CPB. Exclusion criteria were preoperative coagulopathy or anticoagulant therapy. Coagulation was evaluated by standard coagulation assays (prothrombin time, activated partial thromboplastin time, fibrinogen level, platelet count), TEG, CAT and PPL at anaesthesia induction (T1) and after 12h (T2). Perioperative bleeding management was performed according to the institutional guidelines. ResultsForty-nine children aged <24months were enrolled. At T1 ETP and peak height evaluated by CAT were significantly lower in infants aged <6months. Standard coagulation tests, TEG and PPL did not correlate with age. At T2 platelet count, plasmatic fibrinogen level, all TEG parameters, ETP and peak height by CAT were significantly impaired compared to baseline values (T1), despite allogeneic blood product transfusions. ConclusionsThrombin generation is significantly impaired in children affected by congenital heart disease, compared to healthy children and adults. CAT parameters resulted age-dependent, and thrombin generation is lower in infants aged <6months. After cardiac surgery with CPB, a coaugulopathy, revealed by CAT, TEG, but not by PT and aPTT assays, is persistent 12h after surgery despite transfusions of blood products.

Point-of-Care Coagulation Monitoring in Trauma Patients.

Trauma remains one of the major causes of death and disability all over the world. Uncontrolled blood loss and trauma-induced coagulopathy represent preventable causes of trauma-related morbidity and mortality. Treatment may consist of allogeneic blood product transfusion at a fixed ratio or in an individualized goal-directed way based on point-of-care (POC) and routine laboratory measurements. Viscoelastic POC measurement of the developing clot in whole blood and POC platelet function testing allow rapid and tailored coagulation and transfusion treatment based on goal-directed, factor concentrate-based algorithms. The first studies have been published showing that this concept reduces the need for allogeneic blood transfusion and improves outcome. This review highlights the concept of goal-directed POC coagulation management in trauma patients, introduces a selection of POC devices, and presents algorithms which allow a reduction in allogeneic blood product transfusion and an improvement of trauma patient outcome.

Abstract PR586

Background & Objectives: Intraoperative blood loss during scoliosis surgery often leads to blood transfusion1. Predictors of intraoperative blood loss and postoperative effects of intraoperative blood transfusion are extensively investigated2. Most of those studies do not assess postoperative transfusions. Our aim was to investigate the influence of intraoperative allogenic blood transfusion (ALBT) on postoperative blood transfusion rate and early postoperative outcomes. Materials & Methods: In this retrospective study we reviewed data of 202 patients who had scoliosis surgery between 2009-2014. We recorded preoperative hemoglobin levels, surgical times, postoperative first hemoglobin levels, duration of postoperative mechanical ventilation, ICU and PACU stay and postoperative hospital discharge times. Patients were grouped according to the ALBT usage. We first compared patients who received intraoperative transfusions (T+ group) and intraoperatively non transfused patients (T- group). Postoperative mechanical ventilation duration, ICU stay and hospital discharge times were compared between only intraoperatively transfused, only postoperatively transfused, both intra-and-postoperatively transfused, and not transfused patients. Results: Data of 138 women and 64 men were assessed. There were no significant deference between T+ group and T- group regarding the preoperative hemoglobin levels (p= 0.85). Mean operative times in T+ group (n=116) was 339±98 minutes; and 193±106 minutes in T- group (n=86) (p <0,001). Postoperative blood transfusion rates were significantly higher in patients in T+ group (p<0,001) although the postoperative hemoglobin levels were not significantly different (p=0.241). Sixty two % of T+ group patients and 20% of T- group patients received ALBT postoperatively. Although there were no significant difference between mechanical ventilation and ICU stay duration times, hospital discharge times of T+ group were significantly longer than T- group; 7 (min 3- max 22) and 5 (min 2- max16) days respectively (p< 0,001). Postoperative mechanical ventilation times were significantly less in the non-transfused patients compared to only intraoperative transfused patients (p= 0.006) and intra-and-postoperative transfused patients (p< 0,001). Hospital discharge times were also significantly less in the non-transfused group compared to intra-and-postoperative transfused group, (p<0.001). Conclusion: In conclusion, our results reveal that intraoperative blood transfusions have a negative affect on early postoperative results. We can say that the perioperative strategies to decrease blood loss and transfusion of allogenic blood products in scoliosis surgery will be beneficial for our patients.

A BMI &gt;35 does not protect patients undergoing cardiac bypass surgery from red blood cell transfusion

The effect of obesity on allogeneic intraoperative blood product transfusion in patients undergoing coronary artery bypass graft surgery (CABG) is poorly understood. We analyzed the influence of obesity on the risk of intraoperative red blood cell (RBC) transfusion among 45,200 consecutive non-reoperative CABG procedures from a multi-institutional perfusion database. A body mass index (BMI) in obese I category was associated with a 9.9% decrease in transfusion risk (p<0.05). Compared to patients with a normal BMI, obese I and obese III patients do not have any change in the relative risk of RBC transfusion. Overweight and mild obesity have a protective role in reducing intraoperative blood transfusion during cardiopulmonary bypass (CPB) surgery. However, logistic regression analysis showed that much of the observed reduction in transfusion rates for obese patients can be accounted for by other known confounds. The lack of a linear effect of increasing BMI on blood transfusion risk is a novel finding and warrants further investigation.

Randomized evaluation of fibrinogen vs placebo in complex cardiovascular surgery (REPLACE): a double-blind phase III study of haemostatic therapy

BackgroundSingle-dose human fibrinogen concentrate (FCH) might have haemostatic benefits in complex cardiovascular surgery. MethodsPatients undergoing elective aortic surgery requiring cardiopulmonary bypass were randomly assigned to receive FCH or placebo. Study medication was administered to patients with a 5 min bleeding mass of 60–250 g after separation from bypass and surgical haemostasis. A standardized algorithm for allogeneic blood product transfusion was followed if bleeding continued after study medication. Results519 patients from 34 centres were randomized, of whom 152 (29%) met inclusion criteria for study medication. Median (IQR) pretreatment 5 min bleeding mass was 107 (76–138) and 91 (71–112) g in the FCH and placebo groups, respectively (P=0.13). More allogeneic blood product units were administered during the first 24 h after FCH, 5.0 (2.0–11.0), when compared with placebo, 3.0 (0.0–7.0), P=0.026. Fewer patients avoided transfusion in the FCH group (15.4%) compared with placebo (28.4%), P=0.047. The FCH immediately increased plasma fibrinogen concentration and fibrin-based clot strength. Adverse event rates were comparable in each group. ConclusionsHuman fibrinogen concentrate was associated with increased allogeneic blood product transfusion, an unexpected finding contrary to previous studies. Human fibrinogen concentrate may not be effective in this setting when administered according to 5-minute bleeding mass. Low bleeding rates and normal-range plasma fibrinogen concentrations before study medication, and variability in adherence to the complex transfusion algorithm, may have contributed to these results. Clinical trial registrationClinicalTrials.gov identifier no. NCT01475669; EudraCT trial no. 2011-002685-20.

Allogeneic Blood Product Usage in Coronary Artery Bypass Grafting (CABG) with minimalized Extracorporeal Circulation System (MECC) Versus Standard On-Pump Coronary Artery Bypass Grafting.

Aim:Intraoperative allogeneic blood product transfusion (ABPT) in cardiac surgery is associated with worse overall outcome, including mortality. The objective of this study was to evaluate the ABPTs in minimalized extracorporeal cardiopulmonary (MECCTM) compared with standard open system on-pump coronary revascularization.Methods:Data of 156 patients undergoing myocardial revascularization between September 2008 and September 2010 were reviewed. 83 patients were operated by the MECC technique and 73 were treated by standard extracorporeal circulation (sECC). ABPT and overall early postoperative complications were analyzed.Results:Operative mortality and morbidity were similar in both groups. ABPT in the MECC group was significantly lower than in the sECC group both intraoperatively (7.2 vs. 60.3% of patients p<0.001) and during the first five postoperative days (19.3 vs. 57.5%; p<0.001). “Skin to skin”- (214 ± 45 vs. 232 ± 45 min; p=0.012), cardiopulmonary bypass (CPB) - (82 ± 25 vs. 95 ± 26 min; p=0.014), and X-clamp- times (50 ± 16 vs. 56 ± 17 min; p=0.024) were significantly lower in the MECC group than in the sECC group. Length of ICU (intensive care unit) - and hospital stay were also significantly lower in the MECC group vs. the sECC group (26.7 ± 20.2 vs. 54.5 ± 68.9 h; p<0.001, and 12.0 ± 4.1 vs. 14.5 ± 4.6 days; p<0.001).Conclusion:Application of MECC as on-pump coronary artery bypass graft (CABG) results in significantly lower ABPT as well as shorter ICU and in-hospital stay. In order to achieve these benefits of MECC autologous retrograde priming, Bispectral index (BIS) monitoring, intraoperative cell salvage, meticulous hemostasis and strict peri- and postoperative volume management are crucial.

Is viscoelastic coagulation monitoring with ROTEM or TEG validated?

Recent years have seen increasing worldwide interest in the use of viscoelastic coagulation monitoring tests, performed using devices such as ROTEM and TEG. The use of such tests to guide haemostatic therapy may help reduce transfusion of allogeneic blood products in bleeding patients and is supported in European guidelines for managing trauma and severe perioperative bleeding. In addition, viscoelastic tests form the basis of numerous published treatment algorithms. However, some publications have stated that viscoelastic tests are not validated. A specific definition of the term validation is lacking and regulatory requirements of the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have been fulfilled by ROTEM and TEG assays. Viscoelastic tests have been used in pivotal clinical trials, and they are approved for use in most of the world’s countries. Provided that locally approved indications are adhered to, the regulatory framework for clinicians to use viscoelastic tests in routine clinical practice is in place.

Does retrograde autologous priming of the cardiopulmonary bypass circuit have an impact on haematocrit and blood transfusion in uncomplicated coronary artery bypass graft surgery? A retrospective analysis

Haemodilution occuring as a result of cardiopulmonary bypass prime volume increases the need for transfusion of allogenic blood products. Many techniques have been employed to reduce the same. Priming the CPB circuit with the patient's own blood is thought to decrease haemodilution and transfusion requirements.

Changes in the Hemostatic System of Patients With Acute Aortic Dissection Undergoing Aortic Arch Surgery

Aortic arch surgery for patients with acute aortic dissection is frequently complicated by excessive bleeding and transfusion of allogeneic blood products. However, the physiopathology of acute aortic dissection and surgery-induced coagulopathy has never been precisely studied. The aim of the present study is to describe the changes of the perioperative hemostatic system in patients with acute aortic dissection undergoing aortic arch surgery. Sixty-two patients undergoing emergent aortic arch surgery for Stanford type A acute aortic dissection were enrolled in this study from January 2013 to September 2014. The hemostatic system was evaluated using standard laboratory tests, plasma fibrinogen levels, and thromboelastogragh at 5 time points: anesthesia induction (T0), lowest nasopharyngeal temperature (T1), protamine reversal (T2), 4 h after surgery (T3), and on the first postoperative day (T4). The study results revealed that clotting factors had a tendency to be consumed in the preoperative period. Surgery and hypothermia resulted in a progressive reduction in clotting factors, platelet counts, and function, as well as fibrinogen concentration and function. After hemostatic therapy, although platelet counts were constantly low, clotting factors and platelet function returned to nearly preoperative levels. In contrast, fibrinogen concentration and function were still significantly lower than preoperative levels. The results of this prospective analysis showed that acute aortic dissection itself activated the hemostatic system even before surgery. After hemostatic therapy, fibrin formation was more impaired than platelet function. In this setting, we proposed that hemostatic therapy should focus on rapid and sufficient supplementation of fibrinogen. Thus, we recommend further increases in fibrinogen concentration to improve coagulopathy in patients with acute aortic dissection.