Could a simple injection cut blood transfusions in liver transplants?
NCT ID NCT07169643
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests if a drug called darbepoetin can lower the need for blood transfusions during liver transplant surgery. About 140 adults on the liver transplant waiting list with low hemoglobin will receive either the drug or a placebo. The goal is to see if the drug safely reduces the amount of donor blood needed during the operation.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 140 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥ 18 years old 2. Patients on the official liver transplant waiting list 3. Hemoglobin (Hb) level ≤ 11.5 g/dL 4. 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. * A woman will be considered of childbearing potential, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as 0 menses for 12 months without an alternative medical cause. A high follicle stimulating hormone level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single follicle stimulating hormone measurement is insufficient. \*\* Sexual abstinence should only be used as a contraceptive method if it is in line with the subjects' usual and preferred lifestyle. Periodic abstinence (calendar, symptothermal, post ovulation methods) is not an acceptable method of contraception. Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hospital Clinic de Barcelona
RECRUITINGBarcelona, Catalonia, 08036, Spain
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can immune cells predict herpesvirus danger in transplant patients?
- Can a helping hand ease the burden of pediatric liver transplants?