Rescue With Regadenoson (ReWiRe)
A randomised, blinded, controlled, Phase 2a study to evaluate the safety and efficacy of administering Regadenoson to patients with critical injury and signs of haemorrhagic shock
Queen Mary University London
Duration of Study in the UK
1 years, 0 months, 6 days
Trauma is the most frequent cause of death in people under the age of 40. Advances in resuscitation practice including prehospital blood, massive haemorrhage protocols, and novel haemostatic interventions have reduced the number of people dying from haemorrhage. Bleeding and haemorrhagic shock places significant demands on the heart in order to maintain cardiac output in the presence of significantly reduced circulating volume. This can lead to cardiovascular dysfunction, hypoperfusion, and prolonged shock. The impact of this cardiovascular dysfunction can manifest as acute and long-term, as evidenced by the development of Trauma Induced Secondary Cardiac Injury (TISCI), whose development is associated worse outcomes including increased adverse cardiac events and mortality. There is currently no therapeutic agent given to bleeding trauma patients to maintain coronary perfusion in order to support cardiac function, or protect against reperfusion injury associated with hypovolaemia.
Regadenoson is a commercially available A2AR agonist used clinically in myocardial perfusion imaging. Our preclinical animal model of trauma haemorrhage has demonstrated that Regadenoson improves cardiac function post haemorrhage in addition to reducing markers of shock, lowering fluid resuscitation requirements, and improving survival. This acute cardioprotection may mitigate the sequelae of haemorrhagic shock. We now wish to carry out a Phase 2a dose-finding study aimed at testing the safety and efficacy of Regadenoson in traumas with trauma and severe blood loss.
London - Harrow Research Ethics Committee
Date of REC Opinion
18 Jul 2019
Further Information Favourable Opinion