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Study of Epoetin Alfa for Critically Ill Patients with Traumatic Injury

Fast replyRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called epoetin alfa in patients who have experienced a traumatic injury and are critically ill. Traumatic injury refers to serious physical harm that can occur from accidents or other severe impacts. The study involves patients who are on mechanical ventilators, which are machines that help them breathe when they cannot do so on their own.

The purpose of the study is to determine if epoetin alfa can help reduce the risk of death and severe disability in these patients over a period of six months. Epoetin alfa is a medication that is usually given as an injection and is known to help the body produce more red blood cells. In this trial, it is being compared to a placebo, which is a substance with no active medication, to see if it has a beneficial effect on the patients' recovery.

Participants in the study will receive either epoetin alfa or a placebo while they are in the intensive care unit (ICU). The study will monitor their health outcomes over six months to assess the impact of the treatment. The main focus will be on whether the treatment helps reduce mortality and severe disability, as well as other health outcomes like survival rates and the occurrence of certain medical events. The trial is expected to continue until the end of 2025.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient is confirmed to meet the inclusion criteria. This includes being between 18 and 75 years old, having experienced a traumatic injury within the last 24 hours, and being mechanically ventilated in the ICU.

    The patient must have a hemoglobin level within the normal range and informed consent must be obtained from a legal surrogate.

  2. Step 2

    Treatment administration

    The patient receives either epoetin alfa or a placebo. Epoetin alfa is administered as a solution for injection in a pre-filled syringe.

    The specific dosage and frequency of administration are determined by the study protocol and are not detailed in the provided information.

  3. Step 3

    Monitoring and follow-up

    The patient's health is monitored throughout their stay in the ICU. This includes tracking mortality and severe disability outcomes at six months.

    Secondary outcomes such as mortality rates at various stages (ICU, hospital, 28 days) and the occurrence of thrombotic vascular events are also assessed.

  4. Step 4

    Completion of the study

    The study aims to conclude by December 31, 2025. At this point, all data regarding the efficacy of epoetin alfa in reducing mortality and severe disability will be analyzed.

    The primary endpoint is a combination of mortality and severe disability, defined by a specific score, at six months.

Who can join the trial?

7 criteria

  • Patients must have experienced a traumatic injury and be admitted to the ICU (Intensive Care Unit).
  • Patients must be between 18 and 75 years old.
  • The injury must have occurred less than 24 hours before joining the study.
  • Patients must be on a mechanical ventilator, which is a machine that helps with breathing.
  • Patients are expected to stay in the ICU for at least 48 hours.
  • Patients must have a haemoglobin level that is within the normal range for the hospital treating them. Haemoglobin is a protein in red blood cells that carries oxygen.
  • There must be informed consent from a legal representative, which means someone legally allowed to make decisions for the patient agrees to their participation.

Who cannot join the trial?

4 criteria

  • Patients who have a traumatic injury cannot participate. A traumatic injury is a serious physical injury that happens suddenly, like from an accident.
  • Patients who are not within the specified age range cannot participate. The age range for this study is not specified in the provided data.
  • Patients who are not critically ill cannot participate. Being critically ill means having a life-threatening condition that requires intensive medical care.
  • Patients who are not part of the vulnerable population cannot participate. A vulnerable population includes people who may be at greater risk of harm or exploitation.
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Investigated drugs

Erythropoietin Alfa is a medication used in this trial to help reduce mortality and severe disability in critically ill patients who have suffered a traumatic injury. It is being tested to see if it can improve outcomes for patients who are on mechanical ventilation.

What is already known about the treatment

Erythropoietin Alfa – This medication is administered via injection and is currently being studied in clinical trials for its potential benefits in critically ill patients who have suffered traumatic injuries. It is primarily used to reduce mortality and severe disability in these patients. Erythropoietin Alfa works by stimulating the production of red blood cells, which can improve oxygen delivery to tissues. It is classified as a hematopoietic agent, which means it helps in the formation of blood cells.

Investigated diseases

Traumatic Injury – Traumatic injury refers to physical harm or damage to the body caused by an external force, such as accidents, falls, or violence. These injuries can affect any part of the body and vary in severity from minor cuts and bruises to severe, life-altering conditions. The progression of a traumatic injury depends on the nature and extent of the damage. Initially, there may be pain, swelling, and bleeding, followed by potential complications like infection or impaired function of the affected area. Over time, the body may heal naturally, or medical intervention may be required to restore function and prevent further damage. Recovery can be a lengthy process, involving rehabilitation and therapy to regain strength and mobility.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506081-31-00Protocol codeUCDCRC/20/04Estimated enrolment2 607 patientsSponsorUniversity College Dublin

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