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Pediatric off-label use of recombinant factor VIIa
Jeffrey A Alten1, Kim Benner, Kelsey Green
1University of Alabama at Birmingham, 1600 7th Ave South, ACC 504, Birmingham, AL 35233, USA. jalten@peds.uab.edu
Pediatrics
|March 4, 2009
Summary
Recombinant factor VIIa (rFVIIa) effectively reduced blood product use in children, particularly for surgical bleeding, but its use in disseminated intravascular coagulation was associated with high mortality. Thromboembolic events were noted with off-label rFVIIa use.
Area of Science:
- Pediatric Hematology
- Hemostasis and Thrombosis
- Pharmacology
Background:
- Recombinant activated factor VII (rFVIIa) is used off-label for bleeding in nonhemophiliac children.
- Limited data exists on its efficacy and safety in this pediatric population.
Purpose of the Study:
- To report institutional experience with rFVIIa for bleeding treatment and prevention in nonhemophiliac children.
- To evaluate outcomes including blood product use, mortality, and adverse events.
Main Methods:
- Retrospective case series of 135 pediatric patients treated with rFVIIa from 1999-2006.
- Data collected on diagnoses, rFVIIa dosage, blood product administration, and clinical outcomes.
Main Results:
- rFVIIa significantly decreased blood product administration (29.7 vs 11.7 mL/kg).
- Effective bleeding control and low mortality (16%) observed in surgical patients.
- High mortality (93%) in patients with disseminated intravascular coagulation (DIC).
- Thromboembolic events occurred in 3 patients, leading to 2 deaths and 1 amputation.
Conclusions:
- Off-label rFVIIa use is beneficial for surgical bleeding and procedural prophylaxis in children.
- rFVIIa is ineffective for bleeding post-hematopoietic stem cell transplant.
- DIC and multiple organ dysfunction syndrome predict futility of rFVIIa treatment.
- Thromboembolic events are a risk with off-label rFVIIa use in children.
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