Darbepoetin to lower blood transfusions for people awaiting liver transplant
Darbepoetin in Patients Candidates for Liver Transplant: Randomized Clinical Trial Protocol. (EPO-LT Trial)
This trial tests whether monthly darbepoetin given to adults on the liver transplant waiting list can reduce the need for red blood cell transfusions during surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Fundacion Clinic per a la Recerca Biomédica Academic / other |
| Locations | 1 site (Barcelona, Catalonia) |
| Trial ID | NCT07169643 on ClinicalTrials.gov |
What this trial studies
This is a randomized, phase 3, multicenter trial enrolling adults on the liver transplant waiting list with hemoglobin ≤11.5 g/dL. Participants are assigned 1:1 to receive darbepoetin 1.5 mcg/kg subcutaneously monthly (up to three doses) or no darbepoetin, while all patients receive ferric carboxymaltose 1000 mg IV monthly and vitamin B12/folate supplementation as needed. The main aim is to see if darbepoetin reduces intraoperative red blood cell transfusion requirements at the time of transplant. Patients are followed through transplant and for three months after surgery to monitor transfusion use and safety outcomes.
Who should consider this trial
Good fit: Adults (≥18) who are on the official liver transplant waiting list with hemoglobin ≤11.5 g/dL, not pregnant, and able to attend the treating center are ideal candidates.
Not a fit: Patients with hemoglobin above 11.5 g/dL, those with contraindications to erythropoiesis-stimulating agents, or those unable to receive IV iron or attend study visits are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could lower the number of blood transfusions during liver transplant and reduce transfusion-related complications and resource use.
How similar studies have performed: Erythropoiesis-stimulating agents such as darbepoetin have reduced transfusion needs in other surgical and anemic populations, but their use specifically around liver transplantation is less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Barcelona, Catalonia
- Hospital Clinic de Barcelona — Barcelona, Catalonia, Spain (Recruiting)
Study contacts
- Principal investigator: Annabel Blasi, Dr — Fundació de Recerca Clínic Barcelona - Institut D'Investigacions Biomèdiques Agustí Pí i Sunyer
- Study coordinator: Anna cruceta, Dr
- Email: acruceta@recerca.clinic.cat
- Phone: +93 2275400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.