E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Injuries, poisonings, and occupational diseases [C21] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10022117 |
E.1.2 | Term | Injury, poisoning and procedural complications |
E.1.2 | System Organ Class | 10022117 - Injury, poisoning and procedural complications |
|
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
To determine ICU mortality, hospital mortality, 28 days and six -month mortality, GOSE at 6 months, and composite thrombotic events at 6 months. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with trauma admitted to the ICU who: a) Are ≥ 18 to ≤ 75 years of age b) Are < 24 hours since primary traumatic injury c) Are invasively mechanically ventilated d) Are expected to stay in the ICU ≥ 48 hours e) Have a haemoglobin not exceeding the upper limit of the applicable normal (ULN) reference range in clinical use at the treating institution f) Have informed consent from legal surrogate according to local law |
|
E.4 | Principal exclusion criteria |
Patients will be excluded from the study if any of the following criteria apply: a) GCS = 3 and fixed dilated pupils b) History of DVT, PE or other thromboembolic event c) A chronic hypercoagulable disorder, including known malignancy d) Treatment with EPO in the last 30 days e) First dose of study drug unable to be given within 24 hours of primary injury f) Pregnancy or lactation or 3 months post-partum g) Expected to die imminently (< 24 hours) h) Known sensitivity to mammalian cell derived products i) Known contraindication to epoetin alfa j) End stage renal failure (receives chronic dialysis) k) Severe pre-existing physical or mental disability or severe comorbidity that may interfere with the assessment of outcome l) The treating physician believes it is not in the best interest of the patient to be randomised to this trial |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Mortality and disability at 6 months. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
6 months post primary injury |
|
E.5.2 | Secondary end point(s) |
a) Six-month Mortality b) ICU Mortality c) Hospital Mortality d) Dichotomised extended Glasgow Outcome Score (GOSE) favourable (i.e.> 4) at six months e) Proportion of patients with composite thrombotic vascular events (DVT, pulmonary embolism, myocardial infarction, cardiac arrest and cerebrovascular events) at 6 months. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
D28 and 6 months post-primary injury |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
New Zealand |
Saudi Arabia |
Finland |
France |
Germany |
Ireland |
Slovenia |
Switzerland |
European Union |
|
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
End of trial is when the last enrolled patient has completed their 6-month follow up assessment |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |