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NCT Number: NCT06031623

REBOA in Nontraumatic OHCA

The investigators propose a multicenter randomized controlled trial in South Korea and Taiwan to observe the clinical effects of REBOA on nontraumatic out-of-hospital-cardiac-arrest (OHCA) patients. While REBOA has been traditionally used in trauma for hemorrhage control, it has also shown promising results in nontraumatic cardiac arrests by rerouting circulation to increase perfusion in the coronary and brain.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National Univeristy Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location status: Recruiting

Location contact

Hee Eun Kim

CONTACT

[email protected]

About this study

Nontraumatic OHCA patients arriving at the 2 participating hospitals between the ages of 20 to 80 will be eligible. If the patient meets the enrollment criteria, he/she will be randomized into the control group (treatment with conventional ACLS according to the 2020 AHA guideline) or the REBOA group (ACLS according to the 2020 AHA guideline with REBOA application). A sheath catheter is inserted with ultrasound guidance to gain access to the common femoral artery in both groups. This is followed by insertion of the REBOA catheter, if the patient is allocated into the intervention group. The aortic balloon is inflated. If ROSC is achieved, the balloon is deflated slowly. Patients who achieve ROSC will receive post cardiac arrest management according to the 2020 AHA guideline.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult nontraumatic OHCA
  • Witnessed arrest
  • Arrival at ER from 9AM to 5PM (in South Korea) and 8AM to 8PM (in Taiwan)

Exclusion criteria

  • age below 20 years old or over 80 years old,
  • traumatic cardiac arrest,
  • those with unwitnessed cardiac arrest,
  • pregnant patients,
  • patients who have already achieved ROSC upon arrival at the emergency department
  • pre-cardiac arrest cerebral performance category of 3-4
  • those showing evidence of cardiac arrest due to bleeding (such as gastrointestinal bleeding)
  • those suspected of having aortic disease, such as dissection, intramural hematoma, or aneurysm, by bedside ultrasound performed immediately after ED arrival or have a previous history of aortic disease
  • whose legal representative has requested termination of resuscitation efforts before study enrollment
  • declared dead at scene before randomization
  • Patients who meet the criteria for extracorporeal cardiopulmonary resuscitation (ECPR), and therefore the decision is made to perform ECPR, will not be enrolled. The ECPR criteria applies when all of the following criteria are met: pre-cardiac arrest CPC of 1-2, witnessed cardiac arrest with bystander CPR, ages between 20-70, initial shockable rhythm, ECMO pump-on available within 60 minutes of onset of cardiac arrest, and patients without end-stage diseases such as cancer, liver cirrhosis, or end-stage renal failure.

Treatment and study plan

REBOA

Device

Resuscitative endovascular balloon occlusion of the aorta (REBOA)is a device composed of a catheter attached to an inflatable balloon. It is inserted through the common femoral artery and guided to the thoracic aorta.

Primary outcomes

  1. Number of Participants Who Achieved ROSC (return of spontaneous circulation)

    Time frame: 24 hours

    Number of patients who achieves ROSC regardless of sustained time

Secondary outcomes

  1. Number of Participants Who Achieved Sustained ROSC

    Time frame: 24 hours

    Number of participants who achieves sustained ROSC (ROSC maintained more than 20 minutes)

  2. Survival to Admission

    Time frame: 48 hours

    Whether patients who achieve sustained ROSC survives until admission

  3. Survival to Discharge

    Time frame: 30 days

    Whether patients survive until hospital discharge.

  4. Neurological Outcome

    Time frame: 1 month, 3 months, 6 months since ROSC

    The cerebral performance category (CPC) and modified Rankin Score (mRS) of each patient at 28 days, 3 months, and 6 months after achieving ROSC. CPC is measured on a scale of 1 to 5, with 1 being the best neurological performance, and 5 indicating brain death. MRS is measured on a scale of 0 to 6, with 0 indicating no neurological deficit, and 6 indicating death.

  5. Changes in Arterial Blood Pressure

    Time frame: ABP 2 minutes and 1 minute before REBOA insertion, ABP 1 minute / 2 minutes / 4 minutes / 10 minutes after REBOA insertion.

    Arterial blood pressure measured before and after REBOA inflation in the experimental group. Both systolic and diastolic pressures will be used.

Study contacts

Contact information is provided by the study sponsor or research team.

Dong Hyun Jang

CONTACT

[email protected]

82-31-787-7819

Hee Eun Kim

CONTACT

[email protected]

82-31-787-7579

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Far Eastern Memorial Hospital

Registry information

Official study title

Effect Of Resuscitative Endovascular Balloon Occlusion of the Aorta in Non-Traumatic Out-of-Hospital Cardiac Arrest (REBOA); A Multinational, Multicenter Randomized Controlled Trial

Acronym: REBOA

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Sep 11, 2023
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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