Despite the improved screening tests developed in recent years for infectious diseases for blood donors, there still remains a theoretical residual risk of transmission of transfusion-related viruses from single blood components. This mainly relates to donors in the window period of infection and the possible emergence of new pathogens. Octaplas is a virus-inactivated form of fresh frozen plasma (FFP) that, as a consequence of its means of preparation, reduces the risk of transfusion-related viral infections, thereby improving safety. The Canadian Blood Services, which is the distributor of all blood products for nine Canadian provinces and three territories, has been considering a broadening of its product coverage to include Octaplas as an alternative to FFP for certain indications. While several publications claim the in vitro equivalence of Octaplas and FFP in terms of clotting factor activities, the clinical effectiveness of this blood product in the treatment of various indications is not well understood or researched.

In Canada, over 200,000 units of FFP are transfused annually (personal communication, Canadian Blood Services). Given an average dose of four units per transfusion, this represents over 50,000 doses and an estimated cost in excess of $30 million. To assess the relevance of offering Octaplas as an alternative to FP or FFP for distribution to Canadian hospitals, in 2007 we conducted a formal systematic review of the scientific literature, to synthesize evidence about its therapeutic efficacy and safety. Although some reports suggested that Octaplas was safe and effective, the body of literature analyzed was very heterogeneous, making that evidence inconclusive. The purpose of this summary report is to synthesize new evidence released since the original systematic review.

Contents

• REPORT IN BRIEF
• EXECUTIVE SUMMARY
• ABBREVIATIONS
• 1. INTRODUCTION
  • 1.1 Background and Setting in Canada
  • 1.2 Technology Overview
• 2. THE ISSUE
• 3. OBJECTIVE(S)
• 4. CLINICAL REVIEW
  • 4.1 Methods
  • 4.2 Results
• 5. DISCUSSION
  • 5.1 Summary of Results
  • 5.2 Study Limitations
  • 5.3 Generalizability of Findings
  • 5.4 Health Services Impact
  • 5.5 Knowledge Gaps
• 6. CONCLUSIONS
• REFERENCES
• APPENDIX A SEARCH STRATEGIES
• A Systematic Review of Clinical, Laboratory and Safety Outcomes Associated with Use of Octaplas in Multiple Clinical Indications (commissioned in 2007 by and posted with permission from Canadian Blood Services)

Authorship: Madzouka Kokolo, Alan Tinmouth, and Dean Fergusson participated in the preparation of this addendum to the original 2007 unpublished systematic review commissioned and owned by Canadian Blood Services (A Systematic Review of Clinical, Laboratory and Safety Outcomes Associated with Use of Octaplas in Multiple Clinical Indications).

Madzouka Kokolo was the project lead and was involved in all components of the report. She also acted as a liaison between CADTH and the Ottawa Hospital Research Institute (OHRI) during the research process.

Alan Tinmouth was the clinical advisor and participated in research process. He contributed to the identification and abstraction of new data, and to the interpretation of the study findings. He also participated to the writing of the report and reviewed all draft versions of the report.

Dean Fergusson led the planning and research process. He contributed to the identification of new data. He also participated in the writing of the report as well as reviewed and approved all versions of the report. He was also the key liaison between OHRI and CADTH during the commissioning and scoping of the report.

Production of this report is made possible by financial contributions from Health Canada and the governments of Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Northwest Territories, Nova Scotia, Nunavut, Prince Edward Island, Saskatchewan, and Yukon. The Canadian Agency for Drugs and Technologies in Health takes sole responsibility for the final form and content of this report. The views expressed herein do not necessarily represent the views of Health Canada or any provincial or territorial government.

CADTH is funded by Canadian federal, provincial, and territorial governments.

Suggested citation:

Kokolo M, Tinmouth, A, Fergusson, D. Addendum to a Systematic Review of Clinical, Laboratory and Safety Outcomes Associated with Use of Octaplas in Multiple Clinical Indications [Internet]. Ottawa: Canadian Agency for Drugs and Technologies in Health; 2011 (CADTH Optimal Use Report).

CADTH Disclaimer: This report is prepared by the Canadian Agency for Drugs and Technologies in Health (CADTH). This report contains a comprehensive review of existing public literature, studies, materials, and other information and documentation (collectively the “source documentation”) available to CADTH at the time it was prepared and has not been reviewed by peers.

The information in this report is intended to help health care decision-makers, patients, health care professionals, health systems leaders and policy-makers make well-informed decisions and thereby improve the quality of health care services.

The information in this report should not be used as a substitute for the application of clinical judgment in respect of the care of a particular patient or other professional judgment in any decision making process nor is it intended to replace professional medical advice. While CADTH has taken care in the preparation of the report to ensure that its contents are accurate, complete and up-to-date, CADTH does not make any guarantee to that effect. CADTH is not responsible for any errors or omissions or injury, loss, or damage arising from or as a result of the use (or misuse) of any information contained in or implied by the information in this report.

CADTH takes sole responsibility for the final form and content of this report. The statements, conclusions and views expressed herein do not necessarily represent the view of Health Canada or any provincial or territorial government.

Production of this report is made possible through a financial contribution from Health Canada.