Darbepoetin in Patients Candidates for Liver Transplant. (EPO-LT Trial)

Phase 3RecruitingNCT07169643

Fundacion Clinic per a la Recerca Biomédica140 enrolled

Overview

This is a national multicenter, randomized clinical trial to evaluate the the efficacy and safety of DP administration in patients on the liver transplant waiting list to reduce intraoperative red blood cell concentrate transfusion.

Patients will be randomized to receive (1:1): 1. Intervention group: Darbepoetin (DP) 1.5 mcg/kg subcutaneously, monthly (The patients will receive medication monthly until the liver transplant is performed or if it has not yet been transplanted, a maximum of 3 doses) 2. Control group: Do not Darbepoetin All patients will be evaluated to rule out vitamin B12 and folic acid deficiencies, and supplementation with 1000 mcg/day and 10 mg/day, respectively, will be provided if necessary. All patients, on the liver transplant list, will receive ferric carboxymaltose 1000 mg IV (every month) according to standard clinical practice Patients will be followed for 3 months after LT

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

140

Conditions

Liver Transplant; Complications

Interventions

Darbepoetin (DP)DRUG

Darbepoetin (DP) 1.5 mcg/kg subcutaneously, monthly (The patients will receive medication monthly until the liver transplant is performed or if it has not yet been transplanted, a maximum of 3 doses)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Clinic de Barcelona

Barcelona, Catalonia, Spain

RECRUITING

Outcomes

Primary Outcomes

to investigate the efficacy and safety of darbepoetin (DP) administration in patients on the liver transplant (LT) waiting list to reduce intraoperative red blood cell concentrate transfusion.

Difference in the percentage of patients receiving intraoperative (LT) red blood cell transfusions between the intervention group and the control group.

Time frame: perioperative

Secondary Outcomes

Investigate the increase in hemoglobin levels

Absolute differences from baseline in hemoglobin levels basal and at 4, 8, 12 or 16 weeks after the administration of DP, or at the time of liver transplantation, between the intervention group and the control group

Time frame: through study completion, an average of 1 year

Investigate the difference in the percentage of patients receiving intraoperative and during the first 24h after LT, red blood cell concentrate transfusion between the intervention and control groups

Difference in the percentage of patients receiving intraoperative and during the first 24h after LT, red blood cell transfusions between the intervention group and the control group

Time frame: baseline Visit , perioperative visit, month 3 postoperative

Investigate the difference in the percentage of patients receiving intraoperative massive transfusion between the intervention and control groups.

Difference in the percentage of patients receiving massive transfusions(\>6 units of red blood cells)

Time frame: perioperative visit

Investigate the difference in the percentage of patients who developed severe postoperative complications between the intervention and control groups.

assessed by the Comprehensive Charlson Index, between groups

Time frame: Difference in the 3-month severe postoperative complications

Central Contacts

Anna cruceta, Dr

CONTACT

+93 2275400 acruceta@recerca.clinic.cat

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Investigate the difference in the overall cost of the transplantation from surgery to three months post-transplant, between the intervention and control groups.

Difference in the overall cost (direct and indirect) of the transplantation, conducting a cost-effective analysis between groups

Time frame: three months post-transplant

To evaluate the difference in postoperative graft survival , between groups

To evaluate the difference in the 3 month, 6, and 12 months, postoperative graft survival after liver transplantation, between groups

Time frame: the 3 month, 6, and 12 months, postoperative graft survival after liver transplantation, between groups

To investigate the difference in the 3 month, 6, and 12 months, postoperative patient survival after liver transplantation, between groups

To evaluate the difference in the 3 month, 6, and 12 months, postoperative patients' survival after liver transplantation, between groups

Time frame: in the 3 month, 6, and 12 months, postoperative patients survival after liver transplantation

Impact of DP treatment on the hemostatic profile of patients with chronic liver disease, comparing the changes in the following coagulation marker beta-TG at basal and 4 weeks after administration

changes in the beta-TG marker (mg/mL)