Recombinant activated factor VII for bleeding in patients without inherited bleeding disorders
Selin S, Tejani A
Record ID 32006000239
English, French
Authors' objectives:
The aim of this report is to assess the available information on the use of recombinant activated factor VII (rFVIIa) for the prevention and treatment of bleeding in in non-hemophilic patients during surgery, or during treatment for severe trauma or intracerebral hemorrhage (ICH). Also known as eptacog alfa (activated), rFVIIa is a genetically engineered hemostatic agent manufactured by Novo Nordisk in Denmark, it is sold as NiaStase in Canada, and marketed outside Canada as NovoSeven.
Authors' results and conclusions:
In one clinical trial, there was a significant reduction in mortality among patients with ICH treated with rFVIIa. In another trial, administration of rFVIIa significantly reduced the number of trauma patients needing massive blood transfusions, although there was no significant difference in mortality.
Authors' recommendations:
Adequately powered randomized controlled trials are needed to clarify the efficacy and safety of rFVIIa for non-bleeding disorder indications. Phase III trials in ICH and trauma are underway.
rFVIIa may conserve blood components and reduce intensive care stays. More evidence is needed to assess rFVIIa's benefit and harm, optimum dose, time of administration, and cost-effectiveness. Additional issues include which type(s) of hospital(s) should stock rFVIIa, for which indication(s), and which processes should govern its use.
Authors' methods:
Overview
Details
Project Status:
Completed
URL for project:
https://www.ccohta.ca/
Year Published:
2006
English language abstract:
An English language summary is available
Publication Type:
Not Assigned
Country:
Canada
MeSH Terms
- Cerebral Hemorrhage
- Costs and Cost Analysis
- Factor VII
- Hemorrhage
Contact
Organisation Name:
Canadian Coordinating Office for Health Technology Assessment
Contact Address:
600-865 Carling Avenue, Ottawa, ON K1S 5S8 Canada. Tel: +1 613 226 2553, Fax: +1 613 226 5392;
Contact Name:
requests@cadth.ca
Contact Email:
requests@cadth.ca
Copyright:
Canadian Coordinating Office for Health Technology Assessment (CCOHTA)
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.