Background: Recombinant activated factor VII (rFVIIa) has been approved by the U.S. Food and Drug Administration (FDA) for treatment of bleeding in patients with hemophilia A and B and other inhibitors to coagulation factors VIII and IX. However, since rFVIIa's approval, off-label use has increased for clinical situations, leading to the development of numerous side-effects. Case: The clinical course is presented of a high-risk 33-year-old G3P2-0-0-2 parturient with twin gestation, diagnosed with placenta increta via ultrasound during prenatal evaluations. The patient had a cesarean section and a planned hysterectomy after delivery. Significant bleeding was present perioperatively and postoperatively, despite preoperative placement of intraoperative internal tourniquets via bilateral hypogastric balloons. Multiple units of packed red blood cells, fresh frozen plasma, cryoprecipitate, albumin, platelets, and rFVIIa were administered to facilitate hemostasis. Following two doses of rFVIIa, a pulmonary infarction developed, requiring a late pulmonary lobectomy. Results: The patient had a full recovery. Conclusions: rFVIIa should be used as approved by the FDA. Off-label use of rFVIIa should only occur in extenuating emergent hemorrhage situations in which the benefits outweigh the risks of serious postoperative complications. (J GYNECOL SURG 29:203)
Get full access to this article
View all access options for this article.
References
1.
LusherJM, RobertsHR, DavignonGet al.rFVIIa Study Group. A randomized, double-blind comparison of two dosage levels of recombinant factor VIIa in the treatment of joint, muscle and mucocutaneous haemorrhages in persons with haemophilia A and B, with and without inhibitors. Haemophilia, 1998; 4:790.
2.
HoffmanMS, KarlnoskiRA, MangarDet al.Morbidity associated with nonemergent hysterectomy for placenta accreta. Am J Obstet Gynecol, 2010; 202:628.e1.
3.
MangarD, KollaJ, KarlnoskiRAet al.Selective endovascular balloon-occlusion for cesarean delivery in patients with abnormal placentation: Review of literature and presentation of a case. J Gyn Surg, 2009; 25:113.
4.
LoganAC, YankV, StaffordRS. Off-label use of recombinant factor VIIa in U.S. hospitals: Analysis of hospital records. Ann Intern Med, 2011; 154:516.
5.
LeviM, LevyJH, AndersenHF, TruloffD. Safety of recombinant activated factor VII in randomized clinical trials. NEJM, 2010; 363:1791.
6.
O'ConnellKA, WiseRP, LozierJN, BraunM. Thromboembolic adverse events after use of recombinant human coagulation factor VIIa. JAMA, 2006; 295:293.
7.
LeightonBL, WallMH, LockhartEM, Phillips ZattaAJ. Use of recombinant factor VIIa in patients with amniotic fluid embolism: A systematic review of case reports. Anesthesiology, 2011; 115:1201.
8.
LinY, StanworthS, BirchallJet al.Use of recombinant factor VIIa for the prevention and treatment of bleeding in patients without hemophilia: A systematic review and meta-analysis. CMAJ, 2011; 183:E9.
9.
EngströmM, SchöttU, RomnerB, ReinstrupP. Acidosis impairs the coagulation: A thromboelastographic study. J Trauma, 2006; 61:624.
10.
RizoliSB, NascimentoB, OsmanFet al.Recombinant activated coagulation factor VII and bleeding trauma patients. J Trauma, 2006; 61:1419.
11.
LauP, OngV, TanWTet al.Use of activated recombinant factor VII in severe bleeding: Evidence for efficacy and safety in trauma, postpartum hemorrhage, cardiac surgery, and gastrointestinal bleeding. Transfus Med Hemother, 2012; 39:139.
12.
DirkmannD, HankeAA, GörlingerK, PetersJ. Hypothermia and acidosis synergistically impair coagulation in human whole blood. Anesth Analg, 2008; 106:1627.
