cirrhosis bleeding hemorrhage complications hemostasis coagulation
Conditions
Interventions
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 Com
Sponsors
Sanquin Plasma Products
Eligibility
Inclusion criteria
Inclusion criteria: 1. 18y; 2. Cirrhosis, scored as Child-Turcotte- Pugh class B or C or > 13 or as model of end-stage liver disease (MELD) score of > 20; 3. INR>1.5; 4. Signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Previous liver transplantation; 2. Split liver transplantation; 3. Heterotopic liver transplantation; 4. Scheduled multiorgan transplantation; 5. Scheduled living related-donor transplantation; 6. Renal insufficiency requiring dialysis; 7. Documented congenital coagulation disorders; 8. Documented history or presence of portal vein thrombosis; 9. Treatment with warfarin; 10. TIPS (transjugular intrahepatic portosystemic shunt); 11. Fulminant hepatitis; 12. Coronary artery disease; 13. History of thrombophilia (e.g. FVLeiden mutation).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Transfusion requirements per-operative To study the hemostatic efficacy of preoperative PCC administration in patients with cirrhosis undergoing liver transplantation. The hemostatic efficacy will be primarily monitored by recording the need for RBC transfusion. | — |
Secondary
| Measure | Time frame |
|---|---|
| To study the hemostatic safety of preoperative PCC administration in patients with cirrhosis undergoing liver transplantation. The hemostatic safety will be monitored by adverse event surveillance and laboratory measurements, with a special focus on thrombogenicity. | — |
Contacts
Public ContactF. Arshad
Secretariaat Hepatobilaire chirurgie (secretary hepatobilair surgery) UMCG Afdeling Chirurgie, BA33 Postbus 30.001
Outcome results
None listed