Preliminary experience with the use of recombinant factor VIIa to treat coagulation disturbances in pediatric patients
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Updated: Sep 27, 2026

Measurement of Factor V Activity in Human Plasma Using a Microplate Coagulation Assay
Published on: September 9, 2012
Joseph D Tobias1, Kelly Groeper, John W Berkenbosch
1Department of Anesthesiology, University of Missouri, Columbia, MO 65212, USA. Tobiasj@health.missouri.edu
Insights
Recombinant factor VIIa (rVIIa) effectively treats pediatric coagulation dysfunction, even when other treatments fail. This study shows significant improvements in clotting times with no adverse effects, warranting further research.
Area of Science:
- Pediatric Hematology
- Hemostasis and Thrombosis
- Critical Care Medicine
Background:
- Coagulation dysfunction is a critical issue in pediatric patients.
- Standard treatments like fresh frozen plasma may not always be effective.
- Recombinant factor VIIa (rVIIa) is a potential therapeutic option.
Purpose of the Study:
- To evaluate the efficacy of recombinant factor VIIa (rVIIa) in treating coagulation dysfunction in pediatric patients.
- To assess the safety and effectiveness of rVIIa in a pediatric intensive care or operating room setting.
Main Methods:
- Retrospective review of pediatric patients treated with rVIIa.
- Inclusion of case series from existing literature.
- Analysis of coagulation parameters before and after rVIIa administration.
Main Results:
- Ten pediatric patients received 22 doses of rVIIa.
- Seven patients showed no improvement with prior fresh frozen plasma and cryoprecipitate.
- Significant reductions in prothrombin time, international normalized ratio, and partial thromboplastin time were observed post-rVIIa.
- No adverse effects were reported during treatment.
Conclusions:
- Recombinant factor VIIa (rVIIa) effectively reverses coagulation disturbances in pediatric patients.
- rVIIa demonstrates therapeutic potential when conventional treatments like fresh frozen plasma have failed.
- Prospective, randomized trials are recommended to further validate these findings.
Objective:
This study evaluates the efficacy of recombinant factor VII (rVIIa) in the treatment of coagulation dysfunction in pediatric patients.
Methods:
We retrospectively reviewed the records of pediatric patients who received rVIIa in the intensive care unit or operating room for treatment of coagulopathy. Case series in the literature were also reviewed.
Results:
Ten patients, ranging in age from 3 months to 19 years, received 22 doses of rVIIa. Seven of the 10 patients had received fresh frozen plasma and cryoprecipitate before the administration of rVIIa without effect. All 10 patients had a fibrinogen level above 100 mg/dl and platelet count above 100,000/mm3 at the time of rVIla administration. After rVIIa administration, there were significant decreases in prothrombin time, international normalized ratio, and partial thromboplastin time. No adverse effects were noted.
Conclusion:
Recombinant factor VIIa can be used to effectively reverse coagulation disturbances in the pediatric patient even when treatment with fresh frozen plasma has failed. Given its therapeutic potential, prospective, randomized trials are warranted.
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