Study 1
The use of Octaplasma® in patients undergoing open heart surgery6
Objectives
Test whether the tolerability and efficacy of Octaplasma® can compare to FFP in acute surgical situation
Evaluation criteria
Coagulation factors and plasma colloid osmotic pressure
Results
The choice of Octaplasma® versus FFP did not influence the postoperative course
Number of patients: 40
Study 2
Resuscitation of endotheliopathy and bleeding in thoracic aortic dissections: the VIPER-OCTA randomized clinical pilot trial7
Objectives
Compare the effect of coagulation support with S/D-treated pooled plasma (Octaplasma®) versus standard FFP
Evaluation criteria
Glycocalyx and endothelial injury, bleeding, and transfusion requirements
Results
Octaplasma® reduced glycocalyx and endothelial injury, reduced bleeding, transfusions, use of prohemostatics, and time on ventilator after surgery compared to standard FFP
Number of patients: 44
Adapted from the Octaplasma® Product Monograph, Solheim et al, and Stensballe et al.
AE: adverse event; aHUS: atypical haemolytic uremic syndrome; CSP: cryosupernatant plasma; FFP: fresh frozen plasma; FV: factor 5; FVIII: factor 8; FXI: factor 11; HFE: hyperfibrinolic events; HUS: haemolytic uremic syndrome; IQR: interquartile range; LD: liver dysfunction; LT: liver transplant; PEX: plasma exchange; S/D: solvent detergent; TE: thrombotic event; TEE: thromboembolic event; TPE: total plasma exchange; TTP: thrombotic thrombocytopenic purpura.
* Retrospective review and analysis of case notes for 50 consecutive patient episodes of acute TTP treated between February 2003 and December 2005. 12 episodes were treated with CSP only, and 21 episodes were treated with Octaplasma® only. Primary endpoint was the number of PEX to remission.1 [SCULLY p.155A; p.155B; p.155C]
† p=0.06, Mann-Whitney U-test.1 [SCULLY p.155D]
‡ Open label, multicentre trial of pharmacokinetic and hemostatic efficacy in 17 patients with recessively inherited coagulation disorders. Patients received Octaplasma® as replacement therapy for procedures at risk of bleeding (n=14 elective surgery, n=2 vaginal delivery, n=1 emergency surgery). Primary endpoint was the evaluation of treatment efficacy by surgeons and attending physicians.10 [SANTAGOSTINO p.634A; p.634B; p.634C; p.635A]
Effective: actual blood loss did not exceed the expected amount and no bleeding complication occurred; Partially effective: when blood loss exceeded that expected by <50% or when mild bleeding complications were observed.10 [SANTAGOSTINO p.635A]
1. Scully M, Longair I, Flynn M, Berryman J, Machin J. Cryosupernatant and solvent detergent fresh-frozen plasma (Octaplas) usage at a single centre in acute thrombotic thrombocytopenic purpura. Vox Sang. 2007;93(2):154–158.
2. Octaplasma® Product Monograph. Octapharma Canada Inc. October 31, 2022.
3. Haugaa H, Taraldsrud E, Nyrerød HC, et al. Low incidence of hyperfibrinolysis and thromboembolism in 195 primary liver transplantations transfused with solvent/detergent-treated plasma. Clin Med Res. 2013;12(1–2):27–32.
4. Williamson LM, Llewelyn CA, Fisher NC, et al. A randomized trial of solvent/detergent-treated and standard fresh-frozen plasma in the coagulopathy of liver disease and liver transplantation. Transfusion. 1999;39:1227–1234.
5. Hellstern P, Larbig E, Walz GA, Thürigen W, Oberfrank K. Prospective study on efficacy and tolerability of solvent/detergent-treated plasma in intensive care unit patients. Infusionster Transfusionsmed. 1993;20(Suppl 2):16–18.
6. Solheim BG, Svennevig JL, Mohr B, et al. The use of Octaplas in patients undergoing open heart surgery. In: Müller-Berghaus G, ed. DIC: Pathogenesis, Diagnosis and Therapy of Disseminated Intravascular Fibrin Formation. Netherlands: Elsevier Science Publishers BV;1993:253–262.
7. Stensballe J, Ulrich AG, Nilsson JC, et al. Resuscitation of endotheliopathy and bleeding in thoracic aortic dissections: the VIPER-OCTA randomized clinical pilot trial. Anesth Analg. 2018;127(4):920–927.
8. Witt V, Beiglböck E, Würth M, Ritter R. Total plasma exchange using Octaplas; safety and coagulation parameters in children [Abstract 81]. J Clin Apher. 2013;28(2):87–141.
9. Stanley R, Wallis J, Thomas V, Johnstone I, Whitehead S. Use of solvent detergent treated ffp in children with severe sepsis [Abstract SI34]. Transfus Med. 2010:20(Suppl 1):1–25.
10. Santagostino E, Mancuso ME, Morfini M, et al. Solvent/detergent plasma for prevention of bleeding in recessively inherited coagulation disorders: dosing, pharmacokinetics and clinical efficacy. Haematologica. 2006;91:634–639.
11. Josephson CD, Goldstein S, Askenazi D, Cohn CS, Spinella P, Metjian A. Use of solvent/detergent-treated pooled plasma for therapeutic plasma Exchange in children. Poster.
12. Spinella PC, Borasino S, Alten J. Solvent/detergent-treated plasma in the management of pediatric patients who require replacement of multiple coagulation factors: an open-label, multicenter, post-marketing study. Front Pediatr. 2020;8:572. doi: 10.3389/fped.2020.00572.
13. Lee LJ, Roland KJ, Sreenivasan GM, Zypchen LN, Ambler KLS, Yenson, PR. Solvent-detergent plasma for the treatment of thrombotic microangiopathies: A Canadian tertiary care centre experience. Transfus Apher Sci. 2018;57(2):233–235.
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