Study of Darbepoetin Alfa to Reduce Blood Transfusion Needs During Liver Transplant Surgery

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What is this study about?

This study focuses on patients who are candidates for liver transplantation and have low blood levels. The research evaluates the effectiveness and safety of darbepoetin alfa, a medication produced using gene technology in hamster ovary cells. This medicine is given as an injection under the skin to help increase blood levels before transplant surgery.

The main purpose of the study is to determine if using darbepoetin alfa can reduce the need for blood transfusions during liver transplant surgery. The medication will be given to patients who are on the waiting list for liver transplantation and have low hemoglobin levels (a protein that carries oxygen in the blood).

The treatment period lasts up to three months, during which patients receive darbepoetin alfa injections. The study will monitor various aspects of patient health, including blood levels, complications related to liver disease, quality of life, and any side effects from the treatment. Researchers will continue to follow patients for up to one year after their transplant surgery to assess their recovery and the success of the transplant.

1 Initial evaluation

Your initial hemoglobin level will be measured to confirm it is at or below 11.5 g/dL

If you are a woman of childbearing age, a pregnancy test will be performed

Your current health status and medical history will be evaluated

2 Treatment assignment

You will be randomly assigned to either receive darbepoetin alfa treatment or be in the control group

The medication will be given through subcutaneous injection (under the skin)

3 Monitoring period

Your hemoglobin levels will be checked at weeks 4, 8, 12, and 16

Your quality of life will be assessed using a questionnaire called EuroQol-5D

Any health changes or complications will be monitored and recorded

Blood tests will be performed to check various blood markers at the start and after 4 weeks

4 Liver transplant procedure

The amount of blood transfusions needed during your transplant surgery will be recorded

Any complications during the first 24 hours after surgery will be documented

5 Follow-up period

Your health status will be monitored for complications for 3 months after transplant

Additional follow-up visits will occur at 6 and 12 months after transplant

The success of the liver transplant and your overall health will be evaluated during these visits

Who Can Join the Study?

Must be at least 18 years old
Must be officially registered on the liver transplant waiting list
Must have a hemoglobin level of 11.5 g/dL or lower (hemoglobin is a protein in red blood cells that carries oxygen throughout the body)
Women who can become pregnant must:

Have a negative pregnancy blood test before joining the study
Use one of these birth control methods during the study:
- Intrauterine device (a small device placed in the uterus)
- Bilateral tubal occlusion (surgical blocking of both fallopian tubes)
- Have a partner who has had a vasectomy
- Practice complete sexual abstinence for 12 months
Hormonal contraceptives (birth control pills) are not allowed due to possible liver effects

Women are considered unable to become pregnant if they:

Have had their uterus removed (hysterectomy)
Have had both fallopian tubes removed (bilateral salpingectomy)
Have had both ovaries removed (bilateral oophorectomy)
Have not had menstrual periods for 12 months due to natural menopause

Who Cannot Join the Study?

Patients under 18 years of age
Patients with known allergies to darbepoetin or similar medications
Patients with uncontrolled high blood pressure (blood pressure that remains high despite treatment)
Patients with active cancer or history of cancer in the past 5 years
Pregnant women or women who are breastfeeding
Patients with severe heart disease (conditions affecting heart function)
Patients with blood clotting disorders (conditions that affect blood’s ability to form clots)
Patients currently participating in other clinical trials
Patients with iron deficiency anemia (low blood iron levels)
Patients who have received blood transfusions within the last 30 days
Patients with active infections or ongoing inflammatory conditions
Patients unable to provide informed consent
Patients with severe kidney disease (conditions significantly affecting kidney function)

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain
Hospital Universitario Y Politecnico La Fe	Valencia	Spain

Other Sites

Site Name	City	Country
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Universitario De Cruces	Barakaldo	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	15.10.2025

Trial locations

Investigated drugs:

Darbepoetin Alfa

Darbepoetin is a medication that helps the body produce more red blood cells. It is a longer-acting form of erythropoietin, a natural hormone that stimulates red blood cell production in the bone marrow. This medication is used to treat anemia and reduce the need for blood transfusions in patients who are preparing for liver transplant surgery. It works by increasing the number of red blood cells before the operation, which can help reduce the amount of donor blood needed during the transplant procedure.

End-stage Liver Disease – A progressive condition where the liver gradually loses its ability to function properly. The disease develops over time as healthy liver tissue is replaced by scar tissue, affecting the organ’s vital functions. Patients may experience fluid retention, blood clotting problems, and difficulties processing nutrients.

Hepatic Failure – A condition where the liver cannot perform its normal functions, leading to various complications in the body. The liver’s inability to filter toxins, produce essential proteins, and process nutrients affects multiple body systems. This condition can develop either gradually or suddenly.

Portal Hypertension – A condition characterized by increased blood pressure in the portal vein system, which carries blood from the digestive organs to the liver. This increased pressure can cause the development of enlarged vessels and affect blood flow through the liver. The condition commonly develops in patients with chronic liver disease.

Anemia – A condition where the body doesn’t have enough healthy red blood cells to carry adequate oxygen to tissues. In liver disease patients, anemia often develops due to various factors affecting blood cell production and survival. The condition can cause fatigue, weakness, and reduced exercise tolerance.

Trial ID:

2025-521701-41-00

Protocol code:

EPO_LT study

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Darbepoetin Alfa to Reduce Blood Transfusion Needs During Liver Transplant Surgery

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?