This is a national multicenter, randomized clinical trial to evaluate the the efficacy and safety of DP administration in patients on the liver transplant waiting list to reduce intraoperative red blood cell concentrate transfusion.
Age ≥ 18 years old
Patients on the official liver transplant waiting list
Hemoglobin (Hb) level ≤ 11.5 g/dL
Women of child-bearing potential* must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods during the study. Highly effective contraceptive methods will include: intrauterine device, bilateral tubal occlusion, vasectomized partner and sexual abstinence** (only if refraining from heterosexual intercourse during the period of twelve months). Hormonal contraceptive methods will be avoided due to the risk of adverse events and impairment of liver function.
1. Acute/subacute liver failure (see appendix 7) 2. Patients with acute-on-chronic liver failure grade III and/or MELD > 35 3. History of thrombosis, including portal vein thrombosis 4. Significant coronary artery disease (requiring angioplasty and/or coronary stent) 5. Serum ferritin > 800 ng/mL and SAT > 50% 6. Anticoagulant/antiplatelet therapy 7. History of seizures 8. Uncontrolled hypertension (requiring ≥2 antihypertensive drugs) 9. Active infection/sepsis (see appendix 8) 10. Lack of patient consent. 11. Pregnancy or breastfeeding. 12. Patients included in other clinical trials in the month before inclusion. 13. Patients with mental incapacity, language barrier, bad social support or any other reason considered by the investigator precluding adequate understanding, cooperation or compliance in the study.
Parallel
Darbepoetin (DP)
DrugDarbepoetin (DP) 1.5 mcg/kg subcutaneously, monthly (The patients will receive medication monthly until the liver transplant is performed or if it has not yet been transplanted, a maximum of 3 doses)
to investigate the efficacy and safety of darbepoetin (DP) administration in patients on the liver transplant (LT) waiting list to reduce intraoperative red blood cell concentrate transfusion.
Difference in the percentage of patients receiving intraoperative (LT) red blood cell transfusions between the intervention group and the control group.
Investigate the increase in hemoglobin levels
Absolute differences from baseline in hemoglobin levels basal and at 4, 8, 12 or 16 weeks after the administration of DP, or at the time of liver transplantation, between the intervention group and the control group
Investigate the difference in the percentage of patients receiving intraoperative and during the first 24h after LT, red blood cell concentrate transfusion between the intervention and control groups
Difference in the percentage of patients receiving intraoperative and during the first 24h after LT, red blood cell transfusions between the intervention group and the control group
Investigate the difference in the percentage of patients receiving intraoperative massive transfusion between the intervention and control groups.
Difference in the percentage of patients receiving massive transfusions(\>6 units of red blood cells)
Investigate the difference in the percentage of patients who developed severe postoperative complications between the intervention and control groups.
assessed by the Comprehensive Charlson Index, between groups
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