A randomised, blinded, placebo controlled, Phase 2a study to evaluate the safety and efficacy of administering Regadenoson to patients with critical injury and signs of haemorrhagic shock - Rescue With Regadenoson (ReWiRe)

Queen Mary University London0 个研究点目标入组 98 人开始时间: 2019年2月5日最近更新: 2024年9月9日

适应症

试验速览

暂无简介。

•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

•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

发起方