Recombinant activated factor VII for bleeding in patients without inherited bleeding disorders.
(1) Recombinant activated factor VII (rFVIIa) is licensed in Canada for the prevention and treatment of bleeding in hemophiliacs, but it is increasingly used to control bleeding in non-hemophilic patients during surgery, or during treatment for severe trauma or intracerebral hemorrhage (ICH). (2) 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. (3) 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. (4) There is potential for non-hemophilic use, particularly if clinical efficacy and cost effectiveness are established.
Selin
S
S
Tejani
A
A
D002170:Canada; D002543:Cerebral Hemorrhage / Q000188:drug therapy*; D017326:Clinical Trials, Phase III as Topic; D017277:Drug Approval; D015942:Factor VIIa / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D006467:Hemophilia A / Q000188:drug therapy; D006470:Hemorrhage / Q000188:drug therapy* / Q000401:mortality; D006490:Hemostatics / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D006801:Humans; D007432:Intraoperative Period; D017410:Practice Guidelines as Topic; D016032:Randomized Controlled Trials as Topic; D011994:Recombinant Proteins / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D016896:Treatment Outcome; D014481:United States; D014947:Wounds and Injuries / Q000188:drug therapy / Q000401:mortality
D006490:Hemostatics; D011994:Recombinant Proteins; D015942:Factor VIIa