REBOA for Out-of-hospital Cardiac Arrest

Cardiac Arrest Clinical Trial

Official title:

REBOA for Out-of-hospital Cardiac Arrest

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04491903
• Other study ID #: SafeStudy2
• Status: Withdrawn
• Phase: N/A
• Start date: November 30, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: April 2021
• Source: neurescue
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

Procedure:
• REBOA
Endovascular balloon occlusion of the aorta

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
neurescue

Outcome

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