Recombinant Factor VIIA in the Treatment of Bleeding

Madhu V. Midathada, MD; Paulette Mehta, MD; Milton Waner, MD; Louis M. Fink, MD

Disclosures

Am J Clin Pathol. 2004;121(1) 

In This Article

Pregnancy and Surgery

Pregnancy

The use of rFVIIa was reported in a pregnant woman with factor VIIa levels of 1%.[93] rFVIIa had been used prophylactically during pregnancy, and she did not manifest symptoms or signs of excessive bleeding during labor or the puerperium. A woman with a moderate factor VII deficiency and a history of bleeding received rFVIIa continuously during a cesarean section and had no bleeding complications.[76] A pregnant woman with DIC and severe post—cesarean section intra-abdominal bleeding not responding to standard treatment was treated successfully with rFVIIa.[94] Severe intra-abdominal bleeding after cesarean section in a pregnant patient with DIC was reported to have been controlled successfully with rFVIIa.[95]

Surgery

rFVIIa has been used in numerous types of surgery to control bleeding due to preexisting conditions or to manage severe surgical bleeding. Cardiac surgery has been one of the more common situations for the treatment of surgical bleeding. rFVIIa has been used in infants and in elderly people. In 1 report in which 5 patients were treated with a single dose of 30 µg/kg, the blood loss dropped from a mean of 4,170 mL (range, 650-8,000 mL) to 262.5 mL (range, 220-334 mL).[96] The plasma factor VII level increased an average of 18-fold, and the PT was reduced markedly.[96]

Substantial postoperative hemorrhage occurs in 3% to 5% of patients after cardiac surgery with cardiopulmonary bypass; rFVIIa might benefit these patients. Eighteen such patients were identified from an international case registry established to track the investigational use of rFVIIa. The rFVIIa was administered in single or divided doses. Bleeding was reduced in 16 of 18 cases, with total or near complete termination in 9 of 18. Three patients died postoperatively of renal or multiorgan failure, and the others recovered uneventfully.[97] Treatment with rFVIIa has been used before the removal of an intra-aortic balloon pump,[98] for the treatment of refractory bleeding after redo coronary bypass surgery,[99] after aortic valve replacement in a patient with osteogenesis imperfecta,[100] and for intractable bleeding after mitral and tricuspid valve repair.[101]

The use of rFVIIa also has been reported during thyroidectomy in a patient with Hermansky-Pudlak syndrome[102] and during posterior spinal fusion surgery in 2 children with neuromuscular scoliosis.[103] The use of rFVIIa has been reported to prevent bleeding during surgery for uncontrollable rectal hemorrhage[104] and in the management of intractable postsurgical intra-abdominal hemorrhage.[105] The preoperative use of rFVIIa in 36 patients undergoing prostate surgery was reported to reduce blood loss and the need for blood transfusion.[106] The use of rFVIIa in orthopedic procedures has been reported as well, such as in total hip arthroplasty in a patient with cirrhosis and thrombocytopenia[107] and in total knee replacement in a patient with hemophilia with high-titer factor VIII inhibitor.[2] rFVIIa has been used successfully to control bleeding in a preterm infant undergoing exploratory laparotomy for a ruptured umbilical artery[108] and in the surgical resection of a massive pseudotumor in a patient with a high-titer factor VIII inhibitor.[8]

The use of rFVIIa for urgent neurosurgical treatment of patients with coagulopathy seems promising. In a retrospective review of the medical records of 9 patients with coagulopathy needing urgent neurosurgical intervention for various indications, post-rFVIIa coagulation parameters obtained as early as 20 minutes after the infusion of the medication showed normalization of values. No perioperative or postoperative complications were observed.[109,110]

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