Prothrombin Complex Concentrate in the reduction of blood loss during orthotoppic liver transplantation.

In the past decaded, peroperative blood loss and transfusion requirements for cirrhotic patients undergoing liver transplantation have decreased significantly. This is mostly due to restrictive transfusion policy and refinement of surgical and anesthesiological procedures. Major bleeding complications can still occur however. Where cirrhotic patients were used to be considered auto-anticoagulated in the past, due to prolonged conventional coagulation test, its clear in the present dat these coagulation test do not present us with accurate information about the hemostatic ability and dont predict transfusion requirements. Correction of the prolonged coagulation test does not lead to less bleeding.

Intravenous administration of cofact pre-operatively, will reduce the amount of bloodloss and the transfusion requirements in cirrhotic patients undergoing liver ransplantation.

Januari/februari: First inclusion.

2 years to inlcude 140 patients.



Follow-up of patients: Day 1 till 7 postoperative, day 9, day 11, day 30.

The intervention is the intravenous administration of de studyproducts. Depending in which group the patients is randomized, he or she will receive either the placebo (NaCl) or Cofact/ Prothrombin Complex Concentrate. The intervention will take place 30 minutes before start of surgery. De studyproduct will be administered at a rate of 2ml/min, depending on the amount this wil take up to 15 minutes. After this the surgical procedure, othotopic liver transplantation, wil be initiated. We will monitor the amount fo blood loss and amount and type of infusion products administered during the surgical procedures. This includes transfusion of Red Blood Cell's, Fresh Frozen Plasma and also other transfusions such as hemostatic products. After 140 patients are included, we will collect all data to determine what the mean blood loss was in the placebo group versus the studygroup. At the moment, the mean transfused units of Red Blood Cell in participating centra is 8 with a standarddeviation of 4 units. We will perform statistical analysis to determine wether the patients that received Prothrombin Complex Concentrate have a significant decrease in blood loss and transfusion requirements compared to the placebo group. Hereby we can determine wether Prothrombin Complex Concentrate decereases or even prevents blood loss in patient with liver cirrhosis who are undergoing orthotopic liver transplantation.