- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04491903
REBOA for Out-of-hospital Cardiac Arrest
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.
Study Overview
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.
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: REBOA
|
Endovascular balloon occlusion of the aorta
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Central blood pressure
Time Frame: 1 hour
|
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Return of spontaneous circulation (ROSC)
Time Frame: 1 hour
|
1 hour
|
Changes in cardiac rhythm following balloon inflation
Time Frame: 1 hour
|
1 hour
|
During procedure - time from first needle stick to successful sheath insertion
Time Frame: 1 hour
|
1 hour
|
During procedure - time from first needle stick to finalized balloon inflation
Time Frame: 1 hour
|
1 hour
|
End-tidal CO2 (EtCO2)
Time Frame: 1 hour
|
1 hour
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SafeStudy2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on REBOA
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Norwegian University of Science and TechnologySt. Olavs Hospital; Norwegian Air Ambulance FoundationCompletedResuscitative Balloon Occlusion of the Aorta in Non-traumatic Out of Hospital Cardiac Arrest (REBOA)Out-of-Hospital Cardiac ArrestNorway
-
Seoul National University HospitalFar Eastern Memorial HospitalRecruiting
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Queen Mary University of LondonRosetrees Trust; The Drummond Foundation; East Anglian Air Ambulance; The Dowager...RecruitingVentricular Fibrillation | Cardiac Arrest | Ventricular Arrythmia | Cardiac Arrhythmia | Pulseless Electrical Activity | Out-Of-Hospital Cardiac ArrestUnited Kingdom
-
University Hospital Inselspital, BerneCity of BernRecruiting
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University Hospital Inselspital, BerneCompleted
-
University of Alabama at BirminghamWithdrawnVentricular Fibrillation | Ventricular Tachycardia | Cardiac Arrest, Out-Of-HospitalUnited States
-
St. Olavs HospitalNorwegian Air Ambulance FoundationRecruiting
-
Yale UniversityCompletedCardiac ArrestUnited States
-
Barts & The London NHS TrustCompletedEmergencies | Trauma Injury | Trauma, MultipleUnited Kingdom
-
Centre For International HealthUniversity of Padova; Helse Stavanger HF; St. Olavs Hospital; Makerere University; University of Liverpool and other collaboratorsRecruitingPost-partum HemorrhageUganda