Can artificially made human erythropoietin improve recovery after major injuries?

Phase 1

• Conditions: Post-trauma multiple organ failure: a manifestation of the systemic inflammatory/immune response to major injuries.; MedDRA version: 20.0 Level: LLT Classification code 10021459 Term: Immunodeficiency secondary to trauma System Organ Class: 100000004870; MedDRA version: 20.0 Level: LLT Classification code 10028237 Term: Multiple organ failure System Organ Class: 100000004867; MedDRA version: 20.0 Level: LLT Classification code 10044461 Term: Trauma System Organ Class: 10022117 - Injury, poisoning and procedural complications; MedDRA version: 20.0 Level: PT Classification code 10044541 Term: Traumatic shock System Organ Class: 10022117 - Injury, poisoning and procedural complications; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2015-002255-10-GB
• Lead Sponsor: Abertawe Bro Morgannwg University Health Board

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-21
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

The patient is eligible to participate in the study if they:
•have undergone a significant blunt trauma (injury severity score =16)
•have been admitted to ITU with an expected stay >3 days.
•are aged between 18-64 years on admission.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

The patient will not be eligible to participate in the study if they:
•Are pregnant (an admission pregnancy test is routine in all female trauma patients who are of child-bearing age).
•Have a severe isolated traumatic brain injury.
•Have any blood-borne infections e.g. HIV, hepatitis B or C.
•Have any known malignancies.
•Are already participating in another clinical trial.
•Have a contra-indication to thromboprophylaxis.
•Have contra-indications for rhEPO:-
oUncontrolled hypertension.
oKnown sensitivity to mammalian cell derived products.
oHypersensitivity to the active substance or to any of the excipients.
oPatients who have severe coronary, peripheral arterial, carotid or cerebral vascular disease, including patients with recent myocardial infarction or cerebral vascular accident (within 3 months).
oPatients who have developed Pure Red Cell Aplasia (PRCA) following treatment with any erythropoietin.
oA history of thrombo-embolic vascular events (TVEs).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified