Recombinant factor VIIa in the management of postpartum bleeds: an audit of clinical use.
BACKGROUND
This paper presents an analysis of 25 patient cases in which recombinant factor VIIa was used in the management of postpartum hemorrhage, including severe and/or life-threatening bleeds. Anecdotal experiences in the empirical use of this agent are described and dosing regimens, effects on bleeding, and safety data are presented.


METHODS
Data were extracted from the international, internet-based, voluntary registry, haemostasis.com. Search results were manually cross-checked against monthly summary reports and cases of confirmed postpartum hemorrhage were analyzed by the authors. Case providers were contacted individually to approve the use of their cases, supply any missing data, and validate the data already held.


RESULTS
Of 43 reported gynecological admissions for hemorrhage, 13 were excluded as they did not relate to childbirth, and 5 due to insufficient data. The remaining 25 records, all associated with postpartum hemorrhage, were submitted by 14 doctors from 5 countries. Following administration of recombinant factor VIIa, bleeding stopped in 18 cases (72%), markedly decreased in 2 (8%), and decreased in 4 (16%). Bleeding increased following recombinant factor VIIa administration in only 1 patient (4%). Requirements for replacement blood products and crystalloids/colloids were also greatly curtailed. A full recovery was achieved by most patients (22/25, 88%) with few complications, even when recombinant factor VIIa was administered as salvage therapy. There were no thrombotic complications associated with recombinant factor VIIa administration.


CONCLUSIONS
This review provides the largest aggregate of cases in which recombinant factor VIIa has been used to control obstetrical bleeding. A review of these cases suggests that this agent may be a useful and safe adjunctive therapy in the management of postpartum hemorrhage.
Sobieszczyk
Slawomir
S
Division of Hematology-Oncology, Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC, USA.
Breborowicz
Grzegorz H
GH
Platicanov
Viliyan
V
Tanchev
Stoyan
S
Kessler
Craig M
CM
D000328:Adult; D004334:Drug Administration Schedule; D017723:Drug Utilization Review; D005060:Europe; D015942:Factor VIIa / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006489:Hemostatic Techniques / Q000706:statistics & numerical data; D006490:Hemostatics / Q000627:therapeutic use*; D006801:Humans; D008485:Medical Audit; D017063:Outcome Assessment, Health Care; D006473:Postpartum Hemorrhage / Q000188:drug therapy* / Q000473:pathology; D011247:Pregnancy; D011994:Recombinant Proteins / Q000627:therapeutic use*; D012042:Registries
D006490:Hemostatics; D011994:Recombinant Proteins; D015942:Factor VIIa