We're unable to sign you in at this time. Please try again in a few minutes.
We were able to sign you in, but your subscription(s) could not be found. Please try again in a few minutes.
There may be a problem with your account. Please contact the AMA Service Center to resolve this issue.
Contact the AMA Service Center:
Telephone: 1 (800) 262-2350 or 1 (312) 670-7827  *   Email: subscriptions@jamanetwork.com
Error Message ......
Invited Critique |

Efficacy and Safety of Recombinant Activated Factor VII in Major Surgical Procedures: Systematic Review and Meta-analysis of Randomized Clinical Trials—Invited Critique

M. Margaret Knudson, MD
Arch Surg. 2008;143(3):304. doi:10.1001/archsurg.2007.67.
Text Size: A A A
Published online


In 1999, the US Food and Drug Administration approved the use of rFVIIa for the treatment of bleeding episodes in patients with the inherited coagulation disorder hemophilia A or B and inhibitors to factor VIII or IX. Increasingly, however, this product is being used by surgeons to treat patients with acquired coagulopathy, particularly during surgical procedures in which large blood loss is anticipated, such as cardiac, vascular, and liver transplantation surgery. As experience continues to accumulate and the literature documents its effectiveness, this drug is often administered prophylactically to limit transfusion requirements. However, as outlined in the meta-analysis by Ranucci et al, there is considerable variation across studies in the dose used and in the timing of administration. Because the effectiveness of rFVIIa in promoting clot formation may be affected by other factors, such as the platelet count, the fibrinogen level, and the pH at the time of administration, further research in this area is clearly in order. In addition, although most studies document a decrease in transfusion requirements in patients receiving rFVIIa, improvements in mortality rates are not well supported by the small and underpowered studies reviewed. The prohibitive cost of this drug must also be taken into consideration. Most important, there is the potential to do harm by administering a procoagulant in a patient who has other risk factors for thrombosis. In January 2006, O’Connell et al1 released a summary of the adverse events associated with the use of rFVIIa as reported to the Food and Drug Administration. One hundred eighty-five thrombotic events were reported, with most occurring when the drug was administered for an unlabeled use. The total number of patients receiving rFVIIa during that period is unknown, so the number 185 hangs out there as a numerator without a denominator. Mayer et al2 suggested that treatment with rFVIIa within 4 hours of the onset of intracerebral hemorrhage was effective in limiting the size of the hematoma, reduced the mortality rate, and improved functional outcomes at 3 months. However, serious thromboembolic events (including myocardial and cerebral infarction) occurred in 7% of patients treated with rFVIIa vs 2% of those treated with placebo.

Sign in

Purchase Options

• Buy this article
• Subscribe to the journal
• Rent this article ?

First Page Preview

View Large
First page PDF preview





Also Meets CME requirements for:
Browse CME for all U.S. States
Accreditation Information
The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
Note: You must get at least of the answers correct to pass this quiz.
Please click the checkbox indicating that you have read the full article in order to submit your answers.
Your answers have been saved for later.
You have not filled in all the answers to complete this quiz
The following questions were not answered:
Sorry, you have unsuccessfully completed this CME quiz with a score of
The following questions were not answered correctly:
Commitment to Change (optional):
Indicate what change(s) you will implement in your practice, if any, based on this CME course.
Your quiz results:
The filled radio buttons indicate your responses. The preferred responses are highlighted
For CME Course: A Proposed Model for Initial Assessment and Management of Acute Heart Failure Syndromes
Indicate what changes(s) you will implement in your practice, if any, based on this CME course.


Some tools below are only available to our subscribers or users with an online account.

0 Citations

Sign in

Purchase Options

• Buy this article
• Subscribe to the journal
• Rent this article ?

Related Content

Customize your page view by dragging & repositioning the boxes below.

Articles Related By Topic
Related Collections
PubMed Articles