Ignite Creation Date:
2024-05-06 @ 3:17 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04588311
Status:
RECRUITING
Last Update Posted:
2023-10-03
First Post:
2020-10-01
Brief Title:
ErythroPOietin Alfa to Prevent Mortality and Reduce Severe Disability in Critically Ill TRAUMA Patients
Sponsor:
Australian and New Zealand Intensive Care Research Centre
Organization:
Australian and New Zealand Intensive Care Research Centre
Study Overview
Official Title:
A Randomised Double-blind Placebo-controlled Trial of Erythropoietin Alfa Versus Placebo in Mechanically Ventilated Critically Ill Patients Following Traumatic Injury
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPO-TRAUMA
Brief Summary:
The EPO-TRAUMA study is a prospective multi-centre double-blind phase III randomised controlled trial evaluating the efficacy of epoetin alfa compared to placebo in reducing mortality and severe disability at six months in critically ill trauma patients
2500 mechanically ventilated ICU patients admitted with a primary trauma diagnosis presenting to the ICU will be recruited into the study from participating study centres in Australia New Zealand Europe and Saudi Arabia
2500 mechanically ventilated ICU patients admitted with a primary trauma diagnosis presenting to the ICU will be recruited into the study from participating study centres in Australia New Zealand Europe and Saudi Arabia
Detailed Description:
Trauma can cause many injuries some of which are life-threatening and require treatment in an intensive care unit ICU Despite best available treatment and therapies people who sustain a critical traumatic injury are at greater risk of death or long-term disability From 2010 to 2015 approximately 9 of people admitted to an ICU in Australia and New Zealand for treatment of their injuries did not survive In Victoria 6-months post injury approximately 31 of people who were critically injured developed severe disabilities or died
Following a traumatic injury a number of complex pathways are activated by the body These pathways can occur over hours or weeks and may lead to damage of cells tissues or blood vessels and may destroy other healthy tissue The treatment of traumatic injury focuses on trying to minimise further damage that can occur after the initial injury
Erythropoietin is a glycoprotein hormone essential for erythropoiesis and was first purified in 1977 Its human recombinant analogues known as erythropoiesis stimulating agents ESAs are approved for human therapeutic use However erythropoietin is also a pleiotropic cytokine with effects beyond just erythropoiesis Studies in animals have demonstrated the potential protective effects of erythropoietin to organs including the brain kidney liver and heart and anti-inflammatory properties
Previous research suggests the use of the ESA called epoetin alfa increases the number of patients surviving severe trauma and reduces the risk of disability in those who survive
The primary aim of the study is to determine the efficacy of epoetin alfa compared to placebo in reducing mortality and severe disability at six months in critically ill trauma patients
2500 mechanically ventilated ICU patients admitted with a primary trauma diagnosis presenting to the ICU will be recruited into the study from participating study centres in Australia New Zealand Europe and Saudi Arabia
Following a traumatic injury a number of complex pathways are activated by the body These pathways can occur over hours or weeks and may lead to damage of cells tissues or blood vessels and may destroy other healthy tissue The treatment of traumatic injury focuses on trying to minimise further damage that can occur after the initial injury
Erythropoietin is a glycoprotein hormone essential for erythropoiesis and was first purified in 1977 Its human recombinant analogues known as erythropoiesis stimulating agents ESAs are approved for human therapeutic use However erythropoietin is also a pleiotropic cytokine with effects beyond just erythropoiesis Studies in animals have demonstrated the potential protective effects of erythropoietin to organs including the brain kidney liver and heart and anti-inflammatory properties
Previous research suggests the use of the ESA called epoetin alfa increases the number of patients surviving severe trauma and reduces the risk of disability in those who survive
The primary aim of the study is to determine the efficacy of epoetin alfa compared to placebo in reducing mortality and severe disability at six months in critically ill trauma patients
2500 mechanically ventilated ICU patients admitted with a primary trauma diagnosis presenting to the ICU will be recruited into the study from participating study centres in Australia New Zealand Europe and Saudi Arabia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1242-3694 | REGISTRY | None | None |
| 2020-003388-24 | EUDRACT_NUMBER | Australian New Zealand Clinical Trials Registry ANZCTR | None |