Darbepoetin to lower blood transfusions for people awaiting liver transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.