Epo-Trauma

Overview

Sponsor-declared trial summary

Key facts

Sponsor

University College Dublin

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Not possible to specify

Trial duration

29 Mar 2022 → ongoing

Decision date (initial)

2025-04-02

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Belgian Health Care Knowledge Centre (KCE221359) · Medical Research Futures Fund (MRF1170001) · Health Research Council of New Zealand (20/366) · Health Research Board Ireland (DIFA-2018-028)

External identifiers

EU CT number

2023-506081-31-00

EudraCT number

2020-003388-24

ClinicalTrials.gov

NCT04588311

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

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.

Secondary objectives 4

1. ICU, 28-day
2. hospital and six -month mortality
3. GOSE at 6 months
4. Composite thrombotic events at 6 months

Conditions and MedDRA coding

Traumatic Injury

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Patients with trauma admitted to the ICU who: Are ≥ 18 to ≤ 75 years of age
2. Are < 24 hours since primary traumatic injury
3. Are invasively mechanically ventilated
4. Are expected to stay in the ICU ≥ 48 hours
5. Have a haemoglobin not exceeding the upper limit of the applicable normal (ULN) reference range in clinical use at the treating institution
6. Have informed consent from a legal surrogate or have been enrolled prior to obtaining consent according to the law

Exclusion criteria 12

1. GCS = 3 and fixed dilated pupils
2. Recent history of DVT, PE or other thromboembolic event (within previous 12 months or receiving concomitant anticoagulant treatment for this indication)
3. A chronic hypercoagulable disorder, including known malignancy
4. Treatment with EPO in the last 30 days
5. First dose of study drug unable to be given within 24 hours of primary injury
6. Pregnancy or lactation or 3 months post-partum
7. Expected to die imminently (< 24 hours)
8. Known sensitivity to mammalian cell derived products
9. Known contraindication to epoetin alfa
10. End stage renal failure (receives chronic dialysis)
11. Severe pre-existing physical or mental disability or severe co-morbidity that may interfere with the assessment of outcome
12. The treating physician believes it is not in the best interest of the patient to be randomised to this trial

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Combination of Mortality and Severe Disability (defined as a WHODAS 2.0 score ≥25%) at six months

Secondary endpoints 6

1. Six Month Mortality
2. ICU Mortality
3. Hospital Mortality
4. 28 Day Mortality
5. Dichotomised extended Glasgow Outcome Score Extended (GOSE) into favourable (i.e. >4) and unfavourable (i.e. <4) outcomes at six months
6. Proportion of participants with composite thrombotic vascular events (DVT, pulmonary embolism, myocardial infarction, cardiac arrest and cerebrovascular events) at 6 months.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

University College Dublin

Sponsor organisation

University College Dublin

Address

Belfield

City

Dublin 4

Postcode

D04 V1W8

Country

Ireland

Scientific contact point

Organisation

University College Dublin

Contact name

Alistair Nichol

Public contact point

Organisation

University College Dublin

Contact name

EPO-Trauma Project Manager

Third parties 1

Locations

6 EU/EEA countries · 26 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 63 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

9 submissions — initial application plus substantial / non-substantial modifications