Study 1

Use of solvent/detergent-treated pooled plasma for therapeutic plasma exchange in children11

# of patients



Safety and tolerability of S/D plasma in the pediatric population.

Evaluation criteria

Adverse drug reactions, TEs, TEEs, safety laboratory parameters.


Overall safety was assessed as excellent for >90% of patients 24 hours after each TPE. Most ADRs were mild in intensity and were resolved by end of study.

Study 2

Solvent/detergent-treated plasma in the management of pediatric patients who require replacement of multiple coagulation factors: an open-label, multicenter, post-marketing study12

# of patients

50 (0–2 years, n=37; >2 years, n=13)
Cardiac surgery, n=40; LT and/or with LD; sepsis-related coagulopathy, n=4; hypoxic encephalopathy, n=1.


Collect treal-world data on Octaplasma® treatment in paediatric patients with the primary focus being safety.

Evaluation criteria

Serious adverse events, adverse drug reactions, TEs, TEEs, HFEs.


Overall safety ‘excellent’ for all patients. No AEs, no hyperfibrinolytic events and no TEEs related to Octaplasma®

Adapted from Josephson et al and Spinella 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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