1.
Resuscitation of endotheliopathy and bleeding in thoracic aortic dissections: the VIPER-OCTA randomized clinical pilot trial
Stensballe J, Ulrich A G, Nilsson J C, Henriksen H H, Olsen P S, Ostrowski S R, Johansson P I
Anesthesia and Analgesia. 2018;127((4):):920-927
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Abstract
BACKGROUND Thoracic aorta dissection is an acute critical condition associated with shock-induced endotheliopathy, coagulopathy, massive bleeding, and significant morbidity and mortality. Our aim was to compare the effect of coagulation support with solvent/detergent-treated pooled plasma (OctaplasLG) versus standard fresh frozen plasma (FFP) on glycocalyx and endothelial injury, bleeding, and transfusion requirements. METHODS Investigator-initiated, single-center, blinded, randomized clinical pilot trial of adult patients undergoing emergency surgery for thoracic aorta dissection. Patients were randomized to receive OctaplasLG or standard FFP as coagulation factor replacement related to bleeding. The primary outcome was glycocalyx and endothelial injury. Other outcomes included bleeding, transfusions and prohemostatics at 24 hours, organ failure, length of stay in the intensive care unit and in the hospital, safety, and mortality at 30 and 90 days. RESULTS Fifty-seven patients were included to obtain 44 evaluable on the primary outcome. The OctaplasLG group displayed significantly reduced damage to the endothelial glycocalyx (syndecan-1) and reduced endothelial tight junction injury (sVE-cadherin) compared to standard FFP. In the OctaplasLG group compared to the standard FFP, days on ventilator (1 day [interquartile range, 0-1] vs 2 days [1-3]; P = .013), bleeding during surgery (2150 [1600-3087] vs 2750 [2130-6875]; P = .046), 24-hour total transfusion and platelet transfusion volume (3975 mL [2640-6828 mL] vs 6220 mL [4210-10,245 mL]; P = .040, and 1400 mL [1050-2625 mL] vs 2450 mL [1400-3500 mL]; P = .027), and goal-directed use of prohemostatics (7/23 [30.4%] vs 13/21 [61.9%]; P = .036) were all significantly lower. Among the 57 patients randomized, 30-day mortality was 20.7% (6/29) in the OctaplasLG group and 25% (7/28) in the standard FFP group (P = .760). No safety concern was raised. CONCLUSIONS In this randomized, clinical pilot trial of patients undergoing emergency surgery for thoracic aorta dissections, we found that OctaplasLG reduced glycocalyx and endothelial injury, reduced bleeding, transfusions, use of prohemostatics, and time on ventilator after surgery compared to standard FFP. An adequately powered multicenter trial is warranted to confirm the clinical importance of the findings.
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Comparing efficacy and safety of fibrinogen concentrate to cryoprecipitate in bleeding patients: a systematic review
Jensen NH, Stensballe J, Afshari A
Acta Anaesthesiologica Scandinavica. 2016;60((8):):1033-42
Abstract
BACKGROUND Bleeding is associated with the depletion of fibrinogen, thus increasing the risk of coagulopathy, further bleeding and transfusion requirements. Both fibrinogen concentrate and cryoprecipitate replenish low plasma fibrinogen levels. This systematic review aims to identify and evaluate evidence of efficacy and safety of fibrinogen concentrate and cryoprecipitate in bleeding patients. METHOD Cochrane Central Register of Controlled Trials (CENTRAL), Medline, EMBASE up to 2nd of March 2015 were among the electronic search strategies of randomized controlled trials and non-randomized studies with meta-analysis employed. Studies for inclusion required bleeding patients being treated with either fibrinogen concentrate or cryoprecipitate. Mortality was the primary endpoint. Secondary outcomes included bleeding, coagulopathy, transfusion requirements and clinical complications related to the intervention. PRISMA methodology, a data-extraction form and the Cochrane risk of bias tool were all employed. RESULTS Four studies were eligible for inclusion in this systematic review; one randomized controlled trial (RCT) consisting of 66 patients and three observational studies involving 218 patients in total. No mortality was reported in the published papers. There were no differences in fibrinogen-level increase, bleeding, RBC transfusions or thromboembolic complications. The RCT showed a possible increased functional improvement of haemostasis after cryoprecipitate therapy compared to fibrinogen concentrate. CONCLUSION The available evidence directly comparing fibrinogen concentrate to cryoprecipitate is sparse and with high risk of bias. Recommendation of one product over the other for fibrinogen substitution in the bleeding patient with acquired hypofibrinogenaemia is currently not possible. Future research should guide us towards evidence-based decisions of product superiority.
3.
Hemostatic resuscitation for massive bleeding: the paradigm of plasma and platelets--a review of the current literature
Johansson PI, Stensballe J
Transfusion. 2010;50((3):):701-10.
Abstract
BACKGROUND Continued hemorrhage remains a major contributor of mortality in massively transfused patients and controversy regarding the optimal management exists. Recent studies indicate a possible survival benefit in patients receiving a higher ratio of plasma and platelets (PLTs) to red blood cells (RBCs) than what is recommended in current transfusion guidelines. STUDY DESIGN AND METHODS English databases were searched for reports of patients receiving massive transfusion that tested the effects of administration of plasma and/or PLTs in relation to RBCs on survival from January 1990 to March 2009. RESULTS Fourteen retrospective studies involving 4594 patients were identified. Six tested the effect on survival in relation to fresh-frozen plasma (FFP)-to-RBC ratio, and five investigated FFP- and PLT-to-RBC ratios. Two studies evaluated implementation of massive transfusion protocols with preemptive FFP and PLT administration; one study based transfusion therapy on the result of the thrombelastograph (TEG) analysis versus historic controls. All studies reviewed demonstrate a survival benefit for patients who receive more FFP and PLT as part of the hemostatic resuscitation. When TEG was used to guide transfusion therapy an increase in FFP and PLT was also seen when compared to historic controls and this was associated with improved survival. CONCLUSIONS High FFP- and PLT-to-RBC ratios seem to improve survival in patients with massive bleeding. Randomized studies evaluating TEG-guided transfusion therapy versus fixed ratios of plasma and PLTs to RBCs in massively bleeding patients is highly warranted.