Actively Recruiting
Darbepoetin in Patients Candidates for Liver Transplant: Randomized Clinical Trial Protocol. (EPO-LT Trial)
Led by Fundacion Clinic per a la Recerca Biomédica · Updated on 2025-12-18
140
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a national multicenter randomized clinical trial to study the effects of darbepoetin (DP) in patients waiting for a liver transplant. The trial aims to assess the safety and effectiveness of DP in reducing the need for red blood cell transfusions during liver transplant surgery. This phase 3 study also explores how DP influences hemoglobin levels, postoperative complications, graft survival, patient survival, and blood clotting markers in patients with chronic liver disease. Participants will be randomly assigned to one of two groups: the intervention group will receive darbepoetin at a dose of 1.5 mcg/kg by subcutaneous injection once a month, up to three doses or until liver transplant occurs. The control group will not receive darbepoetin. All participants will be evaluated for vitamin B12 and folic acid deficiencies, receiving supplements if needed, and will receive monthly intravenous ferric carboxymaltose as standard care. Participants will be followed for three months post-transplant to monitor outcomes. During the study, participants will undergo evaluations to monitor hemoglobin, coagulation markers, and postoperative health status, including complications and survival rates up to 12 months after transplant. Researchers will also assess quality of life and treatment-related side effects. The primary outcome is the reduction in red blood cell transfusions during surgery. Safety and effectiveness data will be collected regularly throughout the study period, which lasts up to one year on average from enrollment.
CONDITIONS
Brief Title
Darbepoetin in Patients Candidates for Liver Transplant. (EPO-LT Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Patients on the official liver transplant waiting list
- Hemoglobin level of 11.5 g/dL or lower
- Women of child-bearing potential must have a negative pregnancy test before joining and agree to use highly effective contraception methods during the study
You will not qualify if you...
- Acute or subacute liver failure
- Acute-on-chronic liver failure grade III and/or MELD score greater than 35
- History of thrombosis, including portal vein thrombosis
- Significant coronary artery disease requiring angioplasty or stent
- Serum ferritin level above 800 ng/mL and saturation above 50%
- Use of anticoagulant or antiplatelet therapy
- History of seizures
- Uncontrolled hypertension requiring two or more antihypertensive drugs
- Active infection or sepsis
- Lack of patient consent
- Pregnancy or breastfeeding
- Participation in another clinical trial within the past month
- Mental incapacity, language barrier, poor social support, or other factors preventing study compliance
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Until liver transplant or up to 3 months
Participants in the intervention group receive Darbepoetin 1.5 mcg/kg subcutaneously monthly until liver transplant or up to 3 doses. Control group does not receive Darbepoetin. All participants receive ferric carboxymaltose monthly according to standard clinical practice.
Monthly visits for up to 3 months
Duration - 3 months after liver transplant
Participants are followed for 3 months after liver transplant to monitor outcomes and safety.
Approximately 3 post-transplant visits
Trial Site Locations
Total: 1 location
1
Hospital Clinic de Barcelona
Barcelona, Catalonia, Spain, 08036
Actively Recruiting
Research Team
A
Anna cruceta, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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