Elsevier

Transplantation Proceedings

Volume 39, Issue 6, July–August 2007, Pages 1883-1885
Transplantation Proceedings

Liver
Operative procedure/postoperative care
Activated Recombinant Factor VII in Orthotopic Liver Transplantation

https://doi.org/10.1016/j.transproceed.2007.05.062Get rights and content

Abstract

Orthotopic liver transplantation (OLT) is affected by important alterations of hemostasis. The aim of this study was to evaluate the efficacy of recombinant factor VII activated (rFVIIa) to reduce intraoperative bleeding during OLT.

Methods

Twenty OLT patients were assigned in double-blind way to a rFVIIa group or a control group. Inclusion criteria were hemoglobin > 8 g/dL: INR > 1,5 and fibrinogen > 100 mg/dL. We administered a single bouls of rFVIIa (40 μg/kg) or placebo. We determined INR, partial thromboplastin time, fibrinogen, ATIII, and blood cell counts. Blood products were administered as follows: 4 units of fresh frozen plasma when INR > 1.5, and 1 unit of RBC for Hb < 10 g/dL. The study ended 6 hours after the bolus.

Results

No thromboembolic events occurred. The INR was different between rFVIIa group and the controls at T0 (1.9 vs 1.6 P < .021) and during T1 (1.2 vs 1.6 P < .004). The total transfused red blood cells was 300 mL ± 133 in rFVIIa group and 570 mL ± 111 in control group (P < .017). The total fresh frozen plasma was 600 mL ± 154 in rFVIIa group and 1400 mL ± 187 in control group (P < .001). Total blood loss was greater in the control group than the rFVIIa group: 1140 mL ± 112 vs 740 mL ± 131 (P < .049).

Discussion

The use of rFVIIa during OLT can reduce the risk of bleeding during surgery. The literature has described cases who did not benefit from the treatment. An adequate cut-off of INR, allowed us to treat only patients at greater bleeding risk.

Section snippets

Materials and Methods

From November of 2003 to July of 2004, 20 of the 25 patients who underwent OLT met inclusion criteria and were enrolled in our study. All patients were informed and written informed consent was obtained. Inclusion criteria were: Hb > 8 mg/dL, INR > 1,5, Fibrinogen (FBG)> 100 mg/dL. Patients were randomized into two groups according to a double blind scheme: a group rFVIIa (10 patients) and a control group (CTR) (10 patients). The rFVIIa group was administered as a single bolus of 40 μg/Kg

Results

OLT was performed successfully in all patients. Average surgery time was 6 hours and 48 min (SD 56 minutes) in rFVIIa group and 7 hours and 12 minutes (SD 48 minutes) in the CTR group (P = NS). All patients postoperatively were admitted to a dedicated post transplant intensive care unit. Average length of stay in the ICU was 4.8 days (SD 1.3) in rFVIIa group and 5,2 days (SD 1,2) in the CTR group (P = NS). No primary non-function or deaths occurred in either group. One delayed non-function

Discussion

The efficacy of rFVIIa to treat bleeding among patients with congenital or acquired hemophilia is known.6 A previous clinical trial showed similar results in the treatment of bleeding among patients with clotting failure due to cirrhosis. Bernstein corrected PT within 12 hours using three different doses of rFVIIa (5, 20 and 80 μg/Kg) in nonbleeding cirrhotic patients.7 Jeffers, co-author of Bernstein, repeated the study during laparoscopic hepatic biopsy administering four different doses (5,

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