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Updated: May 15, 2026

Measurement of Factor V Activity in Human Plasma Using a Microplate Coagulation Assay
Published on: September 9, 2012
[Risk assessment of thrombotic events after the use of activated factor VII]
M C Martínez López1, A J Alcaraz Romero, A B Martínez López
1Servicio de Cuidados Intensivos Pediátricos, Hospital General Universitario Gregorio Marañón, Madrid, España. m.carmen.martinez11@gmail.com
Insights
Recombinant human factor VIIa (rFVIIa) effectively controls severe bleeding in pediatric cardiac surgery. This therapy did not increase thrombotic complications or mortality rates in the postoperative period.
Area of Science:
- Pediatric Cardiac Surgery
- Hemostasis and Thrombosis
- Pharmacology
Background:
- Severe bleeding is a critical complication in pediatric cardiac surgery.
- Recombinant human factor VIIa (rFVIIa) is used to manage such bleeding.
- The thrombotic risk associated with rFVIIa in this population requires investigation.
Purpose of the Study:
- To analyze the incidence of thrombotic complications in children receiving rFVIIa for severe postoperative bleeding after cardiac surgery.
- To evaluate the safety and efficacy of rFVIIa in this specific patient group.
Main Methods:
- A retrospective matched case-control study was conducted.
- 72 children treated with rFVIIa for severe bleeding post-cardiac surgery were analyzed.
- A control group of 63 comparable patients was selected based on sex, weight, diagnosis, and surgical risk.
Main Results:
- No significant difference in thrombosis rates between rFVIIa-treated patients (20%) and controls (28%, P=.540).
- No significant difference in mortality rates between cases (16%) and controls (9.5%, P=.208).
Conclusions:
- rFVIIa is effective in controlling severe operative bleeding in pediatric cardiac surgery.
- rFVIIa therapy does not appear to elevate the risk of thrombotic complications or mortality post-operatively.
- Findings support the use of rFVIIa as a safe option for managing severe bleeding in pediatric cardiac surgery.
Introduction:
The objective of this study was to analyze the incidence of thrombotic complications related to recombinant human factor viia (rFVIIa) therapy for severe postoperative bleeding in cardiac surgery.
Material And Methods:
A retrospective matched case-control study was conducted over two years, including 72 children admitted to intensive care unit and treated with rFVIIa because of a severe bleeding during or after cardiac surgery. A control group of 63 patients was chosen, who were statistically comparable in sex, weight, diagnosis, surgical risk according RASCH-1 score, and surgical characteristics, was chosen.
Results:
There were no significant differences between cases and controls either in the rate of thrombosis (20% vs 28%, P=.540), or in the mortality rate (16% vs 9.5%, P=.208).
Conclusions:
In our study, the rFVIIa therapy was shown to be useful in controlling severe operative bleeding in pediatric cardiac surgery, but does not seem to increase the risk of thrombotic complications or mortality rate in the postoperative period.
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