Lodge, J. P. A. and Jonas, S. and Oussoultzoglou, E. and Malago, M. and Jayr, C. and Cherqui, D. and Anthuber, Matthias and Mirza, D. F. and Kuhlman, L. and Bechstein, W. O. and Diaz, J. C. M. and Tartiere, J. and Eyraud, D. and Fridberg, M. and Erhardtsen, E. and Mimoz, O. (2005) Recombinant coagulation factor VIIa in major liver resection - A randomized, placebo-controlled, double-blind clinical trial. ANESTHESIOLOGY, 102 (2). pp. 269-275. ISSN 0003-3022, 1528-1175
Full text not available from this repository. (Request a copy)Abstract
Background: Prevention of bleeding episodes in noncirrhotic patients undergoing partial hepatectomy remains unsatisfactory in spite of improved surgical techniques. The authors conducted a randomized, placebo-controlled, double-blind trial to evaluate the hemostatic effect and safety of recombinant factor VIIa (rFVIIa) in major partial hepatectomy. Methods: Two hundred four noncirrhotic patients were equally randomized to receive either 20 or 80 mug/kg rFVIIa or placebo. Partial hepatectomy was performed according to local practice at the participating centers. Patients were monitored for 7 days after surgery. Key efficacy parameters were perioperative erythrocyte requirements (using hematocrit as the transfusion trigger) and blood loss. Safety assessments included monitoring of coagulation-related parameters and Doppler examination of hepatic vessels and lower extremities. Results: The proportion of patients who required perioperative red blood cell transfusion (the primary endpoint) was 37% (23 of 63) in the placebo group, 41% (26 of 63) in the 20-mug/kg group, and 25% (15 of 59) in the 80-mug/kg dose group (logistic regression model; P = 0.09). Mean erythrocyte requirements for patients receiving erythrocytes were 1,024 nil with placebo, 1,354 nil with 20 mug/kg rFVIIa, and 1,036 nil with 80 mug/kg rFVIIa (P = 0.78). Mean intraoperative blood loss was 1,422 nil with placebo, 1,372 nil with 20 mug/kg rFVIIa, and 1,073 nil with 80 mug/kg rFVIIa (P = 0.07). The reduction in hematocrit during surgery was smallest in the 80-mug/kg group, with a significant overall effect of treatment (P = 0.04). Conclusions: Recombinant factor VIIa dosing did not result in a statistically significant reduction in either the number of patients transfused or the volume of blood products administered. No safety issues were identified.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | HEPATIC VASCULAR EXCLUSION; ACTIVATED FACTOR-VII; BLOOD-TRANSFUSION; HEPATOCELLULAR-CARCINOMA; COLORECTAL SURGERY; HEPATECTOMY; INFECTION; RECURRENCE; RFVIIA; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Chirurgie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 28 May 2021 10:13 |
| Last Modified: | 28 May 2021 10:13 |
| URI: | https://pred.uni-regensburg.de/id/eprint/36495 |
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