Erythropoietin to Improve Critical Care Patient Outcomes

NCT05080049 | Unknown Phase 3

• 1 other identifier: EPO-ICU-FS
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief Summary

Recently, the french societies for critical care (SFAR and SRLF) produced guidelines for anemia treatment in critically ill patients that recommend the use of erythropoietin (EPO) in these patients, but the european society (ESICM) recommended against the use of EPO in this patients, despite recent meta analysis showing a lower mortality in patients treated with EPO. Nevertheless, RCT on EPO in the ICU are quite all, new data are thus needed. Before conducting a large study on EPO in anemic patients in the ICU, we propose to cinduct a feasability RCT to evaluate the feasability of such a study.

Conditions

Anemia; Intensive Care

Keywords

Anemia; Intensive Care; Feasibility study; Erythropoietin

Outcome Measures

Primary Outcomes (3)

• Recruitment rate

  ≥50% of eligible patients will need to be enrolled, but the trial will not be feasible if the inclusion rate is ≤ 25% or less

  90 days

• Adherence to allocation groups

  A high level of matching of randomization and group allocation should be achieved, with at least 85% of included patients receiving protocol-allocated treatment, but if ≤ 65% patients receive protocol-allocated treatment, the trial is not feasible

  90 days

• Completion of follow-up of included patients

  ≥ 85% of patients should be followed through to the end of follow-up, but if \<65% patients are followed through to the last visit, the protocol will not be feasible

  90 days

Secondary Outcomes (15)

• The proportion of patients lost to follow-up at each visit

  7, 14, 21, 28 and 90 days

• The rate of missing data for mortality outcome

  90 days

• The rate of compliance with the therapeutic protocol at each visit for inpatients

  7, 14, 21, and 28 days

• Mean serum hemoglobin value

  28 days

• ICU mortality

  up to 90 days

Study Arms (2)

erythropoietin

EXPERIMENTAL

Erythropoietin alpha or theta 40,000 UI (1 ml) sc each week if Hb \<12 g/dL (for maximum 5 weeks)

Drug: Erythropoietin

Placebo

PLACEBO COMPARATOR

saline sc injection (1 ml) each weeks if Hb \<12 g/dL, for a maximum of 5 weeks,

Drug: Placebo

Interventions

Erythropoietin DRUG

Patients receive a subcutaneous injection of 40,000 IU of erythropoietin alfa or zêta, repeated weekly until Day 28 (if the hemoglobin level is \<12 g/dl and the patient remains hospitalized). The study treatments are administered by an open-label nurse. In both groups, before each injection, iron deficiency (defined as reticulocyte Hb \<29 pg, or hepcidin \<41 µg/L, or ferritin \<100 µg/L, or ferritin \<300 µg/L with transferrin saturation \<20%) is treated with intravenous iron infusion (depending on the product available at the center). A restrictive transfusion strategy is recommended as long as the patient remains in the ICU, according to recent recommendations. Six visits are scheduled: V1 for inclusion and the first injection, V2 at Day 7(±2 days) for the second injection, V3 at Day 14(±2 days) for the third injection, V4 at Day 21(±2 days) for the fourth injection, V5 at Day 28(±2 days) for the fifth injection.

erythropoietin

Placebo DRUG

In the control arm, patients receive a subcutaneous injection of placebo (0.9% NaCl) according to the same schedule. The study treatments are administered by an open-label nurse. In both groups, before each injection, iron deficiency (defined as reticulocyte Hb \<29 pg, or hepcidin \<41 µg/L, or ferritin \<100 µg/L, or ferritin \<300 µg/L with transferrin saturation \<20%) is treated with intravenous iron infusion (depending on the product available at the center). A restrictive transfusion strategy is recommended as long as the patient remains in the ICU, according to recent recommendations. Six visits are scheduled: V1 for inclusion and the first injection, V2 at Day 7(±2 days) for the second injection, V3 at Day 14(±2 days) for the third injection, V4 at Day 21(±2 days) for the fourth injection, V5 at Day 28(±2 days) for the fifth injection.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (age \> 18 years),
• admitted to intensive care for more than 72 hours and less than 7 days
• who have received invasive ventilatory support and/or treatment with a vasoactive agent for at least one day since admission
• with an Hb level \< 12 g/dl,

You may not qualify if:

• Moribund patient,
• Current hospitalization for acute coronary syndrome,
• Recent history of thromboembolic event (\< 3 months),
• Uncontrolled hypertension despite adequate antihypertensive therapy,
• Myelodysplasia or chronic pathology requiring iterative transfusions,
• EPO treatment within the last 30 days,
• Participation in another interventional trial of an erythropoiesis-stimulating agent or anemia treatment,
• Expected discharge from the intensive care unit within 24 hours,
• Known hypersensitivity to EPO or any of its components,
• A history of erythroblastopenia following erythropoietin therapy
• Pregnant, breast-feeding or parturient woman
• Person deprived of liberty by judicial or administrative decision
• Person under forced psychiatric care
• Person under a legal protection measure.

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (2)

Cholet Hospital

Cholet, France

Location

UH Tours

Tours, France

Location

MeSH Terms

Conditions

Anemia

Interventions

Erythropoietin

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Maxime Léger, MD

  Angers University Hospital

  PRINCIPAL INVESTIGATOR

• Sigismond Lasocki, MD

  Angers University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: October 15, 2021
• Study Start: January 28, 2022
• Primary Completion: September 2, 2022
• Study Completion: December 31, 2022
• Last Updated: October 10, 2022

Record last verified: 2022-09

Locations

FR (2)