Plasma transfusion in liver transplantation: a randomized, double-blind, multicenter clinical comparison of three virally secured plasmas
Bartelmaos T, Chabanel A, Leger J, Villalon L, Gillon MC, Rouget C, Gomola A, Denninger MH, Tardivel R, Naegelen C, et al
BACKGROUND The clinical equivalence of plasma treated to reduce pathogen transmission and untreated plasma has not been extensively studied. A clinical trial was conducted in liver transplant recipients to compare the efficacy of three plasmas. STUDY DESIGN AND METHODS A randomized, equivalence, blinded trial was performed in four French liver transplantation centers. The three studied (fresh-frozen) plasmas were quarantine (Q-FFP), methylene blue (MB-FFP), and solvent/detergent (S/D-FFP) plasmas. The primary outcome was the volume of plasma transfused during transplantation. Secondary outcomes included intraoperative blood loss, hemostasis variables corrections, and adverse events. RESULTS One-hundred patients were randomly assigned in the MB-FFP, 96 in the S/D-FFP, and 97 in the Q-FFP groups, respectively. The median volumes of plasma transfused were 2254, 1905, and 1798 mL with MB-FFP, S/D-FFP, and Q-FFP, respectively. The three plasmas were not equivalent. MB-FFP was not equivalent to the two other plasmas, but S/D-FFP and Q-FFP were equivalent. The median numbers of transfused plasma units were 10, 10, and 8 units with MB-FFP, S/D-FFP, and Q-FFP, respectively. Adjustment on bleeding risk factors diminished the difference between groups: the excess plasma volume transfused with MB-FFP compared to Q-FFP was reduced from 24% to 14%. Blood loss and coagulation factors corrections were not significantly different between the three arms. CONCLUSION Compared to both Q-FFP and S/D-FFP, use of MB-FFP was associated with a moderate increase in volume transfused, partly explained by a difference in unit volume and bleeding risk factors. Q-FFP was associated with fewer units transfused than either S/D-FFP or MB-FFP. 2012 American Association of Blood Banks.
Solvent detergent vs. fresh frozen plasma in cirrhotic patients undergoing liver transplant surgery: a prospective randomized control study
Bindi ML, Miccoli M, Marietta M, Meacci L, Esposito M, Bisa M, Mozzo R, Mazzoni A, Baggiani A, Scatena F, et al
Vox Sanguinis. 2013;105((2):):137-43.
BACKGROUND Although orthotopic liver transplantation (OLT) is nowadays considered standard practice at experienced centres, it can still be affected by a significant risk of massive bleeding and its related complications. Solvent/detergent plasma (S/D Plasma) has been proposed as an alternative to fresh frozen plasma (FFP) to curtail such complications. This study aimed at evaluating the efficacy of S/D Plasma in OLT patients by comparing it to FFP. MATERIALS AND METHODS Sixty-three OLT patients were randomized into two groups depending on whether they were transfused with FFP or S/D plasma. A thromboelastography-based protocol aimed at achieving and maintaining predetermined coagulation goals was used to guide plasma transfusions. At the beginning and the end of surgery, standard laboratory coagulation tests were performed together with the assessment of the VII, VIII, V, XII factors and S protein blood levels. RESULTS The two study groups equally achieved the thromboelastography goals but with a reduced amount of transfusions in the S/D plasma group (P<0.0001). At the end of surgery, factors V and XII and S protein blood levels were lower in the S/D plasma patients who also showed lower INR, aPTT and antithrombin III levels. CONCLUSION In cirrhotic patients undergoing OLT, the use of S\D plasma associated with thromboelastography allows the same clinical results but with a significant reduction in the amount of plasma transfusions. 2013 International Society of Blood Transfusion.
The use of cryosupernatant plasma in complex treatment of pancreonecrosis Russian
Tseimakh EA, Bombizo VA, Buldakov PN, Siniavin AV, Osipov ES, Meliksetian AD, Orekhov DA, Smirnova OI
Comparative study of results of complex treatment of pancreonecrosis in 60 patients using cryosupernatant plasma (CSNP) and fresh frozen plasma was carried out. Better positive dynamics in some laboratory indices, less lethality and better outcomes were marked with use of CSNP. It can be used instead of fresh frozen plasma in complex treatment of pancreonecrosis and concomitant DIC syndrome.
Comparison of RBCs and FFP with whole blood during liver transplant surgery
Laine E, Steadman R, Calhoun L, Blackall D, Levin P, Braunfeld M, Nourmand H, Neelakanta G, Ting L, Gornbein J, et al
BACKGROUND Component therapy has become the accepted standard of care in transfusion medicine. In instances of large blood loss, the transfusion of whole blood rather than the combination of RBCs and FFP is rational and may be preferred. STUDY DESIGN AND METHODS In a controlled, prospective, randomized study of 33 patients undergoing orthotopic liver transplantation, the effectiveness of component therapy (RBCs and FFP) was compared with the use of whole blood. Coagulation tests (prothrombin time and activated partial thromboplastin time), clotting factor levels (FV, FVIII, fibrinogen), platelet counts, the number of donor exposures, and the total volume of blood transfused for the whole-blood group and the component-therapy group were compared at designated times before surgery, during surgery, and 24 hours after surgery. RESULTS There was a significant difference (p=0. 015) in the median number of donor exposures for RBCs and FFP, with fewer occurring in the whole-blood group (n=14. 5) compared with the component group (n=25). There was no significant difference between groups in coagulation profiles during any of the phases of surgery except for a mild decrease in fibrinogen levels in the whole-blood group at the conclusion of surgery. There were no differences between the groups in the median volume of blood component replacement, the median age of blood components, the patients' Hct or the number of RBC-containing components transfused. CONCLUSION Whole blood, when compared with component therapy, is associated with fewer donor exposures yet provided equally effective replacement therapy for blood loss in liver transplantation patients.
Effective control of hepatic bleeding with a novel collagen-based composite combined with autologous plasma: results of a randomized controlled trial
Chapman WC, Clavien PA, Fung J, Khanna A, Bonham A
Archives of Surgery. 2000;135((10):):1200-4; discussion 1205.
HYPOTHESIS A novel collagen-based composite of bovine microfibrillar collagen and bovine thrombin combined with autologous plasma is more effective than standard hemostasis (collagen sponge applied with pressure) in controlling diffuse hepatic bleeding after hemihepatectomy or segmental resection of the liver. DESIGN Randomized controlled trial. SETTING Seven university-affiliated medical centers. PATIENTS Sixty-seven adult patients scheduled for hemihepatectomy or segmental resection who received hemostatic intervention with an investigational treatment (n = 38) or control (n = 29). INTERVENTION Bleeding hepatic tissue was managed in all control subjects with a collagen sponge with manual pressure. Subjects in the experimental group had the sprayable liquid composite intraoperatively applied to the surgical site. The liquid immediately formed a collagen-fibrin gel that was used without concomitant tamponade. MAIN OUTCOME MEASURES Hemostatic success was defined as the proportion of subjects in each treatment group who achieved complete hemostasis within 10 minutes. Success rates and median times required to achieve controlled bleeding (ie, slight oozing) and complete hemostasis were compared between treatment groups. RESULTS All 38 subjects in the experimental group achieved complete hemostasis within 10 minutes compared with only 69% (20/29) of control subjects (P<.001). The median time to controlled bleeding was approximately 4 times longer (250 vs 62 seconds) for control subjects than for experimental group subjects (P<.001). The median time required to achieve complete hemostasis also favored the experimental group (150 vs 360 seconds; P<.001). No adverse events related to the use of the experimental hemostatic agent were detected. CONCLUSIONS The experimental composite is more effective at controlling and stopping diffuse hepatic bleeding than a collagen sponge applied with pressure; it may be a useful hemostatic agent for patients undergoing hemihepatectomy, segmental resection, and related surgical procedures.
A randomized trial of solvent/detergent-treated and standard fresh-frozen plasma in the coagulopathy of liver disease and liver transplantation
Williamson LM, Llewelyn CA, Fisher NC, Allain JP, Bellamy MC, Baglin TP, Freeman J, Klinck JR, Ala FA, Smith N, et al
BACKGROUND Virus inactivation of pooled fresh-frozen plasma (FFP) by the solvent/detergent (SD) method results in a loss of approximately 20 percent of factor VIII. This study aimed to assess the efficacy of SD-treated plasma in correcting the coagulopathy associated with liver disease and liver transplantation. STUDY DESIGN AND METHODS Forty-nine patients with coagulation deficits due to liver disease, who required FFP for invasive procedures or liver transplantation, were randomly assigned to receive either FFP or SD-treated plasma. Patients were assessed for side effects, correction of coagulopathy over 24 hours, and seroconversion for viral markers 6 to 18 months after treatment. RESULTS In the liver disease group, equal correction of clotting factors and partial thromboplastin time was seen with FFP and SD-treated plasma, with a similar return to baseline values over 24 hours. There was greater correction of the International Normalised Ratio in patients receiving SD-treated plasma (p = 0.037), but this patient group had higher baseline values than recipients of FFP (p = 0.024). Liver transplant patients also showed equivalent correction of coagulopathy with the same dose of FFP and SD-treated plasma. The use of other blood components during transplantation was identical in the two treatment groups. No seroconversions were seen for HIV or hepatitis B or C virus. One patient who had received FFP seroconverted for human parvovirus B19. Apparent seroconversion for hepatitis A virus seen at 9 to 13 months in four other patients was probably due to detection of passively transferred antibodies, as later testing of these patients gave negative results. Minor side effects were rare in both groups. CONCLUSION SD-treated plasma is an efficacious source of coagulation factors for patients with liver disease who are undergoing biopsy or transplantation. Assessment of seroconversion for viral markers in recipients of plasma-derived products and plasma components should include consideration of the possibility that passively transferred antibodies were detected.
A randomized trial of solvent/detergent and standard fresh frozen plasma in the treatment of the coagulopathy seen during Orthotopic Liver Transplantation
Freeman JW, Williamson LM, Llewelyn C, Fisher N, Allain JP, Bellamy M, Baglin TP, Klinc J, Ala FA, Smith N, et al
Vox Sanguinis. 1998;74((Suppl 1):):225-9.
BACKGROUND Viral transmission remains a residual risk in single unit blood component therapy. Virus inactivation of pooled fresh frozen plasma (FFP) by the solvent/detergent (SD) method can be used to reduce this risk but results in some loss of factor activity including factor VIII and (2-antiplasmin. This study was aimed at assessing the clinical effectiveness solvent/detergent treated pooled fresh frozen plasma (SDFFP) in the correction of the coagulopathy seen during Orthotopic Liver Transplantation (OLT) as compared with standard FFP. METHOD Twenty eight patients with an underlying derangement of coagulation and who were due to undergo OLT were randomized to receive either FFP or SDFFP. They were assessed for side effects, correction of coagulopathy, and seroconversion for viral markers. RESULTS Patients undergoing OLT showed equal correction of clotting factors and partial thromboplastin time (PTT) when treated with FFP or SDFFP. There was also a similar time course to return to baseline values in each group. There was no significant difference in correction of INR in either group. Usage of other blood components during the operation was identical in the two groups. No seroconversions were seen for HIV, HBC or HCV but only 12 patients were available for long term follow-up. CONCLUSION SDFFP is an efficacious and safe source of coagulation factors for patients with liver disease undergoing Orthotopic Liver Transplantation. No adverse effects were seen during its administration. Further work is required to ascertain long term possibilities of seroconversion.