NCT04491903

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2020

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 30, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

November 30, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

May 4, 2021

Status Verified

April 1, 2021

Enrollment Period

Same day

First QC Date

July 22, 2020

Last Update Submit

April 29, 2021

Conditions

Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

  • Central blood pressure

    1 hour

Secondary Outcomes (5)

  • 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

Study Arms (1)

REBOA

EXPERIMENTAL
Procedure: REBOA

Interventions

REBOAPROCEDURE

Endovascular balloon occlusion of the aorta

REBOA

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2020

First Posted

July 30, 2020

Study Start

November 30, 2020

Primary Completion

November 30, 2020

Study Completion

November 30, 2020

Last Updated

May 4, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Individual request