REBOA for Out-of-hospital Cardiac Arrest

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04491903

Enrollment

Registered

2020-07-30

Start date

2020-11-30

Completion date

2020-11-30

Last updated

2021-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest

Brief summary

Cardiac arrest is a major health problem that carries a high mortality rate. Substantial research and development have been put into changing the outcome of cardiac arrest and despite the advent of automated external defibrillators (AED), increase in bystander Cardiopulmonary resuscitation (CPR) and automated CPR devices (ACPR), the proportion of patient survival to hospital discharge has only minimally improved. The objective is to investigate safety and performance of the Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) procedure as an adjunct to Advanced Life Support (ALS) for treatment of refractory cardiac arrest.

Detailed description

The scope of the study is to collect data on patients with refractory out of hospital cardiac arrest (OHCA) for this feasibility study. Data collected: * from enrolment of the patient until hospital arrival * every 24 hours * at discharge or 7 days post enrollment * at 30 days post enrollment The investigation is initiated to investigate the safety and performance of the REBOA procedure for patients experiencing refractory OHCA.

Interventions

PROCEDUREREBOA

Endovascular balloon occlusion of the aorta

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Witnessed cardiac arrest * Bystander or professional CPR within 5 minutes * Refractory cardiac arrest

Exclusion criteria

* End Tidal CO2 \<1,3 kPa * Traumatic cardiac arrest * Women with known pregnancy * Patients with known terminal disease * Patients with known do-not-attempt-CPR order * Patients with overdose

Design outcomes

Primary

Measure	Time frame
Central blood pressure	1 hour

Secondary

Measure	Time frame
Return of spontaneous circulation (ROSC)	1 hour
Changes in cardiac rhythm following balloon inflation	1 hour
During procedure - time from first needle stick to successful sheath insertion	1 hour
During procedure - time from first needle stick to finalized balloon inflation	1 hour
End-tidal CO2 (EtCO2)	1 hour

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026