Rescue with Regadenoson (ReWiRe)

Phase 1

• Conditions: Cardiovascular collapse following traumatic haemorrhage; Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]

• Registration Number: EUCTR2018-003284-62-GB
• Lead Sponsor: Queen Mary University London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-05
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 98

Inclusion Criteria

•Male
•Deemed to be aged =18 and =70 years
•Activated pre-hospital code-red criteria (activation criteria are: systolic blood pressure <90 mmHg, AND suspected haemorrhage).
•Started transfusion of at least 1 unit of PRBCs (or blood component equivalent)
•Is intubated and ventilated
•Patient has suffered a traumatic injury
•Is able to be randomised within 1 hour of the pre-hospital physician arriving at the scene of the injury

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 86
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

•Patient suffered a traumatic cardiac arrest prior to screening
•Patients who are suspected to have shock due a non-haemorrhagic cause, as assessed by the pre-hospital care team
•Time of IMP/Placebo administration not attainable prior to admission to the receiving hospital
•Presence of obvious catastrophic traumatic brain injury or other non-survivable injury, diagnosed by the pre-hospital team
•Known or suspected pre-injury cardiac disease
•Known allergy to regadenoson

Study & Design

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