Recombinant coagulation factor VIIa in major liver resection: a randomized, placebo-controlled, double-blind clinical trial.
ABSTRACT 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.
Two hundred four noncirrhotic patients were equally randomized to receive either 20 or 80 microg/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.
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-microg/kg group, and 25% (15 of 59) in the 80-microg/kg dose group (logistic regression model; P = 0.09). Mean erythrocyte requirements for patients receiving erythrocytes were 1,024 ml with placebo, 1,354 ml with 20 microg/kg rFVIIa, and 1,036 ml with 80 microg/kg rFVIIa (P = 0.78). Mean intraoperative blood loss was 1,422 ml with placebo, 1,372 ml with 20 microg/kg rFVIIa, and 1,073 ml with 80 microg/kg rFVIIa (P = 0.07). The reduction in hematocrit during surgery was smallest in the 80-microg/kg group, with a significant overall effect of treatment (P = 0.04).
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.
- [show abstract] [hide abstract]
ABSTRACT: Over the last 5 years, a policy to limit blood transfusions has been adopted in patients undergoing liver resection. The aim of this retrospective study was to report the results of 150 liver resections performed during this period. There were 63 major (42%) and 87 minor hepatectomies (58%). Resection was performed for malignant lesions in 64% of the patients. Vascular exclusion of the liver was used in large (> or = 10 cm) tumors and those located at the cavohepatic junction. Clamping of the portal triad or selective clamping of the pedicle of the portal lobe was used in peripheral lesions < 10 cm in diameter. Anesthesia was adapted to the type of vascular clamping and blood transfusions were deliberately limited. Red blood cells were transfused to maintain the hematocrit level above 25% in healthy patients and above 30% in patients with risk of coronary artery disease. Ninety three patients (62%) did not receive blood transfusions. Three patients received more than 10 units of packed red blood cells (2%). 48% of patients with major hepatectomies and 72% with minor hepatectomies were not transfused. The rate of non transfused patients was 93% for benign lesions and 44% for malignant lesions. The presence of pathologic changes in non-tumor liver parenchyma did not influence the need for transfusions. Hospital mortality was 3% (5/150). There was no mortality in patients with normal non-tumorous livers, 14% in the presence of cirrhosis, and 12% in the presence of obstructive jaundice or steatosis > 50%. The specific morbidity rate was 7% in patients with normal livers and 54% in patients with abnormal livers. This series shows that more than 60% of liver resections can be performed without blood transfusions. These results require an appropriate surgical technique and collaboration between anesthesiologist and surgeon. Thus hepatectomies in normal non-tumorous livers can be performed without mortality. In contrast, the presence of abnormalities of the non-tumorous liver parenchyma remains a major risk factor.Gastroentérologie Clinique et Biologique 03/1996; 20(2):132-8. · 1.14 Impact Factor
- [show abstract] [hide abstract]
ABSTRACT: Several studies suggest that perioperative blood transfusion is a major independent risk factor for postoperative bacterial infections. Transfusion-induced immunosuppression is thought to mediate this effect. In a randomized clinical trial comprising 697 patients with colorectal cancer, the relationship between two types of red cell components (buffy coat-depleted packed red cells and white cell-reduced [filtered] packed red cells) and postoperative bacterial infections was analyzed. Both types of red cells appeared to be associated with a greater incidence of postoperative infection than was no transfusion (39 vs. 24%, p < 0.01). A dose-response relationship could be demonstrated: the corrected relative risk was 1.6 for 1 to 3 units of red cells and 3.6 for more than 3 units. Multivariate analyses identified the transfusion of red cells and tumor location as the only significant independent risk factors for postoperative bacterial infection. Because allogeneic white cells, plasma, microaggregates, citrate, and platelets could be ruled out as risk factors for transfusion-associated postoperative infections, it is hypothesized that the transfusion of red cells is a potentially detrimental factor that transiently impairs the clearance of bacteria by phagocytic cells.Transfusion 02/1997; 37(2):126-34. · 3.53 Impact Factor
- [show abstract] [hide abstract]
ABSTRACT: A retrospective study was carried out of 522 elective liver resections to determine the impact of blood transfusion on the immediate postoperative outcome and on long-term survival. The number of liver resections without transfusion has increased in recent years, as a result of improvement in surgical technique with less blood loss during operation and more careful choice of the timing of transfusion. In resections carried out in the past 5 years, the indication for intraoperative transfusion was restricted and the decision was made jointly by the surgeon and anaesthetist, and in any case only if the haematocrit was below 25 per cent. Of resections carried out in the past 2 years, 59 per cent did not require intraoperative transfusion. Postoperative deaths and complications were related to blood transfusion, particularly in patients with cirrhosis, in whom stepwise logistic regression analysis showed that transfusion was the only factor that correlated significantly with complications. Transfusion also affected the long-term survival of patients operated on for hepatocellular carcinoma and colorectal carcinoma metastases in univariate analysis and was the only factor shown by multivariate analysis to correlate with survival for hepatocellular carcinoma in patients with cirrhosis.British Journal of Surgery 09/1995; 82(8):1105-10. · 4.84 Impact Factor