This is a randomised, parallel group, multi-centre, phase II clinical trial with a primary objective to assess the efficacy of REBOA in study subjects suffering from non-traumatic out of hospital cardiac arrest (OHCA). Patients are randomised in a 1:1 ratio to be included to the control group or the intervention group. 200 patients will be included in the trial. The control group receives ACLS according to national guidelines and the intervention group receives ACLS according to national guidelines and the REBOA procedure as an adjunct treatment.
The primary endpoint of this study is the proportion of patients that achieve return of spontaneous circulation (ROSC).
This is the first prospective trial in the world to assess the efficacy of REBOA in non-traumatic cardiac arrest. The intervention is shown feasible in the pre-hospital setting. If this trial provides a signal of benefit in patients, this study could initiate further clinical research which could change current resuscitation practice world-wide.
This is a multi-centre trial, with centres being consecutively recruited. Centres may include helicopter and/or rapid response car.
We anticipate that the intervention will provide an improvement in both systolic and diastolic blood pressure. This could potentially improve perfusion of the brain and heart during CPR. Brain tissue is highly sensitive to hypoxemia and improved systolic blood pressure, with possible improved perfusion of the brain, is likely beneficial. The potential clinical benefit in this trial is therefore increased rate of ROSC and survival to hospital, possibly also improved 30-day survival rate.
PM – Project Manager
CI – Chief Investigator