Clinical trial • Phase III • Other
EPOETIN ALFA for Traumatic injury
Phase III trial of EPOETIN ALFA for Traumatic injury.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Traumatic injury
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 11-04-2024
- First CTIS Authorization Date
- 17-05-2024
Trial design
Randomised, placebo arm: sodium chloride 0.9% 1ml, administered by subcutaneous injection; imp arm: epoetin-alfa 40000 iu in a 1ml pre-filled syringe, administered by subcutaneous injection.-controlled Phase III trial across 26 sites in Ireland, Germany, Finland and others.
- Randomised
- Yes
- Comparator
- Placebo Arm: Sodium Chloride 0.9% 1ml, administered by subcutaneous injection; IMP Arm: epoetin-alfa 40000 IU in a 1mL pre-filled syringe, administered by subcutaneous injection.
- Target Sample Size
- 1600
- Trial Duration For Participant
- 183
Eligibility
Recruits 1600 Critically ill, mechanically ventilated trauma patients are identified as a vulnerable population (isVulnerablePopulationSelected = true). Consent provisions: "Have informed consent from a legal surrogate or have been enrolled prior to obtaining consent according to the law." Study documents include subject information and informed consent forms, relative/legal representative consent forms, telephone assent forms, assent forms, and patient consent-to-continue forms, and locally translated/site-specific versions to support surrogate/assent processes..
- Pregnancy Exclusion
- Pregnancy or lactation or 3 months post-partum
- Vulnerable Population
- Critically ill, mechanically ventilated trauma patients are identified as a vulnerable population (isVulnerablePopulationSelected = true). Consent provisions: "Have informed consent from a legal surrogate or have been enrolled prior to obtaining consent according to the law." Study documents include subject information and informed consent forms, relative/legal representative consent forms, telephone assent forms, assent forms, and patient consent-to-continue forms, and locally translated/site-specific versions to support surrogate/assent processes.
Inclusion criteria
- {"criterion_text":"- Patients with trauma admitted to the ICU who: Are ≥ 18 to ≤ 75 years of age\n- Are < 24 hours since primary traumatic injury\n- Are invasively mechanically ventilated\n- Are expected to stay in the ICU ≥ 48 hours\n- Have a haemoglobin not exceeding the upper limit of the applicable normal (ULN) reference range in clinical use at the treating institution\n- Have informed consent from a legal surrogate or have been enrolled prior to obtaining consent according to the law"}
Exclusion criteria
- {"criterion_text":"- GCS = 3 and fixed dilated pupils\n- End stage renal failure (receives chronic dialysis)\n- Severe pre-existing physical or mental disability or severe co-morbidity that may interfere with the assessment of outcome\n- The treating physician believes it is not in the best interest of the patient to be randomised to this trial\n- Recent history of DVT, PE or other thromboembolic event (within previous 12 months or receiving concomitant anticoagulant treatment for this indication)\n- A chronic hypercoagulable disorder, including known malignancy\n- Treatment with EPO in the last 30 days\n- First dose of study drug unable to be given within 24 hours of primary injury\n- Pregnancy or lactation or 3 months post-partum\n- Expected to die imminently (< 24 hours)\n- Known sensitivity to mammalian cell derived products\n- Known contraindication to epoetin alfa"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Combination of Mortality and Severe Disability (defined as a WHODAS 2.0 score ≥25%) at six months","definition_or_measurement_approach":"Defined as combination of mortality and severe disability where severe disability is specified as a WHODAS 2.0 score ≥25% assessed at six months."}
Secondary endpoints
- {"endpoint_text":"- Six Month Mortality","definition_or_measurement_approach":"All-cause mortality assessed at six months."}
- {"endpoint_text":"- ICU Mortality","definition_or_measurement_approach":"Mortality occurring during ICU stay."}
- {"endpoint_text":"- Hospital Mortality","definition_or_measurement_approach":"Mortality occurring during the hospital admission."}
- {"endpoint_text":"- 28 Day Mortality","definition_or_measurement_approach":"All-cause mortality assessed at 28 days."}
- {"endpoint_text":"- Dichotomised extended Glasgow Outcome Score Extended (GOSE) into favourable (i.e. >4) and unfavourable (i.e. <4) outcomes at six months","definition_or_measurement_approach":"GOSE dichotomised: favourable outcome >4, unfavourable outcome <4, assessed at six months."}
- {"endpoint_text":"- Proportion of participants with composite thrombotic vascular events (DVT, pulmonary embolism, myocardial infarction, cardiac arrest and cerebrovascular events) at 6 months.","definition_or_measurement_approach":"Composite of specified thrombotic vascular events (DVT, PE, MI, cardiac arrest, cerebrovascular events) assessed up to six months."}
Recruitment
- Planned Sample Size
- 1600
- Recruitment Window Months
- 69
- Consent Approach
- For incapacitated critically ill patients consent is obtained from a legal surrogate or patients may be enrolled prior to obtaining consent in accordance with applicable law. Study documentation includes patient information and informed consent forms, relative/legal representative consent forms, telephone assent forms, assent forms, and patient consent-to-continue forms; site- and country-specific translated versions are provided.
Geography
- Total Number Of Sites
- 26
- Total Number Of Participants
- 1157
Ireland
- Earliest CTIS Part Ii Submission Date
- 01-05-2024
- Latest Decision Or Authorization Date
- 20-04-2026
- Processing Time Days
- 719
- Number Of Sites
- 5
- Number Of Participants
- 75
Sites
- Site Name
- Mater Misericordiae University Hospital
- Department Name
- Intensive Care Unit
- Contact Person Name
- Aisling McMahon
- Contact Person Email
- AislingMcMahon@mater.ie
- Site Name
- Beaumont Hospital
- Department Name
- Intensive Care Unit
- Contact Person Name
- Ger Curley
- Contact Person Email
- gercurley@rcsi.com
- Site Name
- St Vincent's University Hospital
- Department Name
- Critical Care Centre
- Contact Person Name
- Alistair Nichol
- Contact Person Email
- alistair.nichol@ucd.ie
- Site Name
- Tallaght University Hospital
- Department Name
- Intensive Care Unit
- Contact Person Name
- Yvelynne Kelly
- Contact Person Email
- yvelynne.kelly@tuh.ie
- Site Name
- Cork University Hospital
- Department Name
- Intensive Care Unit
- Contact Person Name
- Patrick Seigne
- Contact Person Email
- patrick.seigne@hse.ie
Germany
- Earliest CTIS Part Ii Submission Date
- 01-05-2024
- Latest Decision Or Authorization Date
- 22-04-2026
- Processing Time Days
- 721
- Number Of Sites
- 2
- Number Of Participants
- 210
Sites
- Site Name
- Universitätsklinikum Münster
- Department Name
- Intensive Care
- Contact Person Name
- Alex Zarbock
- Contact Person Email
- zarbock@uni-muenster.de
- Site Name
- Tübingen University Hospital
- Department Name
- Intensive Care
- Contact Person Name
- Peter Rosenberger
- Contact Person Email
- Peter.rosenberger@md.uni-tuebingen.de
Finland
- Earliest CTIS Part Ii Submission Date
- 01-05-2024
- Latest Decision Or Authorization Date
- 23-04-2026
- Processing Time Days
- 722
- Number Of Sites
- 3
- Number Of Participants
- 180
Sites
- Site Name
- Turku University Hospital
- Department Name
- Intensive Care Unit
- Contact Person Name
- Timo Laitio
- Contact Person Email
- timo.laitio@tyks.fi
- Site Name
- Kuopio University Hospital
- Department Name
- Intensive Care Department
- Contact Person Name
- Stepani Bendel
- Contact Person Email
- stepani.bendel@kuh.fi
- Site Name
- HUS-Yhtymae
- Department Name
- Emergency Care and Services
- Contact Person Name
- Markus Skrifvars
- Contact Person Email
- markus.skrifvars@hus.fi
Slovenia
- Earliest CTIS Part Ii Submission Date
- 01-05-2024
- Latest Decision Or Authorization Date
- 20-04-2026
- Processing Time Days
- 719
- Number Of Sites
- 2
- Number Of Participants
- 90
Sites
- Site Name
- University Medical Center Ljubljana
- Department Name
- Intensive Care
- Contact Person Name
- Anja Kramaric
- Contact Person Email
- anja.kramaric@kclj.si
- Site Name
- UNIVERZITETNI KLINICNI CENTER MARIBOR
- Department Name
- Anaesthesiology, Intensive care and Pain Management
- Contact Person Name
- Andreja Moller Petrun
- Contact Person Email
- andreja@moellerpetrun.net
France
- Earliest CTIS Part Ii Submission Date
- 01-05-2024
- Latest Decision Or Authorization Date
- 20-04-2026
- Processing Time Days
- 719
- Number Of Sites
- 7
- Number Of Participants
- 420
Sites
- Site Name
- Centre Hospitalier Universitaire De Nimes
- Department Name
- Intensive Care
- Contact Person Name
- Claire Roger
- Contact Person Email
- claire.roger@chu-nimes.fr
- Site Name
- Hopital Beaujon
- Department Name
- Intensive Care
- Contact Person Name
- Emmanuel Weiss
- Contact Person Email
- emmanuel.weiss@aphp.fr
- Site Name
- Amiens-Picardie University Hospital
- Department Name
- Intensive Care
- Contact Person Name
- Stéphanie Malaquin
- Contact Person Email
- Malaquin.Stephanie@chu-amiens.fr
- Site Name
- Bicetre Hospital
- Department Name
- Intensive Care
- Contact Person Name
- Anatole Harrois
- Contact Person Email
- anatole.harrois@aphp.fr
- Site Name
- Caen University Hospital
- Department Name
- Intensive Care
- Contact Person Name
- Valentin LeFrancois
- Contact Person Email
- lefrancois-v@chu-caen.fr
- Site Name
- CHU de Rouen - Hôpital Charles Nicolle
- Department Name
- Intensive Care
- Contact Person Name
- Thomas Clavier
- Contact Person Email
- Thomas.Clavier@chu-rouen.fr
- Site Name
- Grenoble University Hospital Center
- Department Name
- Intensive Care
- Contact Person Name
- Marie Christine Herault
- Contact Person Email
- mcherault@chu-grenoble.fr
Belgium
- Earliest CTIS Part Ii Submission Date
- 11-03-2025
- Latest Decision Or Authorization Date
- 20-04-2026
- Processing Time Days
- 405
- Number Of Sites
- 7
- Number Of Participants
- 182
Sites
- Site Name
- CHR Citadelle
- Department Name
- Intensive Care Unit
- Contact Person Name
- François Pitance
- Contact Person Email
- Francois.pitance@citadelle.be
- Site Name
- Ziekenhuis Oost-Limburg
- Department Name
- Critical Care Unit
- Contact Person Name
- Xavier Willaert
- Contact Person Email
- xavier.willaert@zol.ie
- Site Name
- Ghent University Hospital
- Department Name
- Intensive Care Department
- Contact Person Name
- Klaas Vanderbiest
- Contact Person Email
- klaas.vanderbiest@uzgent.be
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Intensive Care Unit
- Contact Person Name
- Maximilien Thoma
- Contact Person Email
- maximilien.thoma@saintluc.uclouvain.be
- Site Name
- CHU Charleroi Chimay
- Department Name
- Intensive Care Unit
- Contact Person Name
- Michael Piagnerelli
- Contact Person Email
- michael.piagnerelli@humani.be
- Site Name
- AZ Delta VZW, Roeselare
- Department Name
- Anaesthesiology and Intensive Care Unit
- Contact Person Name
- Alexander Dumoulin
- Contact Person Email
- alexander.domoulin@azdelta.be
- Site Name
- Erasme Hospital
- Department Name
- Intensive Care Unit
- Contact Person Name
- Fabio Taccone
- Contact Person Email
- fabio.taccone@hubruxelles.ie
Sponsor
Primary sponsor
- Full Name
- University College Dublin
- Organisation Type
- Educational Institution
- Country Of Registered Address
- Ireland
Third parties
- {"country":"Australia","full_name":"Monash University","duties_or_roles":"Codes: 1,10,13,4,5,6,8","organisation_type":"Educational Institution"}
Investigational products
- Investigational Product Name
- Epoetin alfa HEXAL 40,000 IU/1 mL solution for injection in a pre-filled syringe
- Active Substance
- EPOETIN ALFA
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Subcutaneous injection (solution for injection in a pre-filled syringe)
- Route
- Subcutaneous
- Authorisation Status
- Marketing authorisation number EU/1/07/411/051
- Starting Dose
- 40000 IU (1 mL pre-filled syringe)
- Investigational Product Name
- Binocrit 40,000 IU/1 mL solution for injection in a pre-filled syringe
- Active Substance
- EPOETIN ALFA
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Subcutaneous injection (solution for injection in a pre-filled syringe)
- Route
- Subcutaneous
- Authorisation Status
- Marketing authorisation number EU/1/07/410/051
- Starting Dose
- 40000 IU (1 mL pre-filled syringe)
- Investigational Product Name
- EPREX 40000 UI/ml, solution injectable en seringue préremplie
- Active Substance
- EPOETIN ALFA
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Subcutaneous injection (solution for injection in a pre-filled syringe)
- Route
- Subcutaneous
- Authorisation Status
- Marketing authorisation number 34009 369 925 9 7
- Starting Dose
- 40000 IU (1 mL pre-filled syringe)
- Investigational Product Name
- Placebo (Sodium Chloride 0.9%)
- Active Substance
- -
- Modality
- Other
- Routes Of Administration
- Subcutaneous injection (1 mL Sodium Chloride 0.9%)
- Route
- Subcutaneous
- Starting Dose
- 1 mL (Sodium Chloride 0.9%)
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