Systematic review: benefits and harms of in-hospital use of recombinant factor VIIa for off-label indications
View abstract on PubMed
Summary
This summary is machine-generated.Recombinant factor VIIa (rFVIIa) use for off-label indications like bleeding or surgery did not reduce mortality. However, it increased the risk of thromboembolism in some cases, with limited evidence strength.
Area Of Science
- Hematology
- Pharmacology
- Critical Care Medicine
Background
- Recombinant factor VIIa (rFVIIa) is approved for hemophilia but increasingly used off-label.
- This study investigates its efficacy and safety in five common in-hospital, off-label indications.
Purpose Of The Study
- To evaluate the benefits and harms of recombinant factor VIIa (rFVIIa) for intracranial hemorrhage, cardiac surgery, trauma, liver transplantation, and prostatectomy.
- Assessing the strength of evidence for these off-label uses.
Main Methods
- Systematic review of 10 databases (PubMed, EMBASE, Cochrane Library) up to December 2010.
- Inclusion of randomized controlled trials (RCTs) and observational studies.
- Independent assessment of study characteristics, quality, and strength of evidence.
Main Results
- 16 RCTs and 48 observational studies were analyzed.
- rFVIIa did not improve mortality in intracranial hemorrhage.
- Increased thromboembolism risk observed with medium and high-dose rFVIIa for intracranial hemorrhage and in cardiac surgery.
- Reduced acute respiratory distress syndrome risk noted in trauma patients.
Conclusions
- The evidence for most outcomes and indications is of low quality and strength.
- Limited data suggests no mortality benefit from rFVIIa in these off-label uses.
- Potential for increased thromboembolism risk with rFVIIa in certain patient populations.