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Cardiopulmonary ArrestREBOANCT06031623

REBOA in Nontraumatic OHCA

A study testing REBOA in people with Cardiopulmonary Arrest, run by Seoul National University Hospital at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Cardiopulmonary Arrest
What is being tested?
REBOA
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
234 participants
Where
1 siteSouth Korea
Study dates
17 Oct 2023to 1 Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hee Eun Kim contact

82-31-787-7579

hekim9111@gmail.com

Dong Hyun Jang contact

82-31-787-7819

jang0621@gmail.com

South Korea1 site, 1 recruiting

  • Seoul National Univeristy Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

    Hee Eun Kim, hekim9111@gmail.com

    Recruiting

Other trials in South Korea

About this study

Official 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

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.

Read the detailed description

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.

Being tested
REBOA
Keywords
Advanced cardiopulmonary resuscitation (ACLS), Cardiopulmonary resuscitation (CPR), Resuscitative endovascular balloon occlusion of the aorta (REBOA)
Medical subject headings
Heart Arrest

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • REBOADevice

    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.

Study groups in NCT06031623
Study groupRoleWhat they receive
ControlNo interventionPatients allocated to this arm receives conventional resuscitative measures according to the 2020 AHA CPR Guidelines.
REBOAExperimentalAfter enrollment and randomization, patients allocated to this arm receives REBOA in addition to conventional ACLS according to the 2020 AHA CPR guidelines. The common femoral artery is accessed with ultrasound guidance. A sheath catheter is inserted, followed by a REBOA catheter. The REBOA is ballooned with 20cc of normal saline or until resistance is felt.
Receives: Device: REBOA

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Number of patients who achieves ROSC regardless of sustained time

    Measured: 24 hours

Secondary outcomes (5)

  1. Number of Participants Who Achieved Sustained ROSC

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

    Measured: 24 hours

  2. Survival to Admission

    Whether patients who achieve sustained ROSC survives until admission

    Measured: 48 hours

  3. Survival to Discharge

    Whether patients survive until hospital discharge.

    Measured: 30 days

  4. Neurological Outcome

    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.

    Measured: 1 month, 3 months, 6 months since ROSC

  5. Changes in Arterial Blood Pressure

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2023
  2. Study start17 Oct 2023
  3. Primary completion1 Oct 2025 (estimated)
  4. Study completion1 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
234 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06031623
Sponsor's protocol ID
Interventional
Acronym
REBOA
Status last verified
Jan 2025
First submitted
2 Sep 2023
Last updated
28 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jang DH, Lee DK, Jo YH, Park SM, Oh YT, Im CW. Resuscitative endovascular occlusion of the aorta (REBOA) as a mechanical method for increasing the coronary perfusion pressure in non-traumatic out-of-hospital cardiac arrest patients. Resuscitation. 2022 Oct;179:277-284. doi: 10.1016/j.resuscitation.2022.07.020. Epub 2022 Jul 21.

    PubMed 35870557

  • Brede JR, Lafrenz T, Klepstad P, Skjaerseth EA, Nordseth T, Sovik E, Kruger AJ. Feasibility of Pre-Hospital Resuscitative Endovascular Balloon Occlusion of the Aorta in Non-Traumatic Out-of-Hospital Cardiac Arrest. J Am Heart Assoc. 2019 Nov 19;8(22):e014394. doi: 10.1161/JAHA.119.014394. Epub 2019 Nov 11.

    PubMed 31707942

  • Mazzoli CA, Chiarini V, Coniglio C, Lupi C, Tartaglione M, Gamberini L, Semeraro F, Gordini G. Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in Non-Traumatic Cardiac Arrest: A Narrative Review of Known and Potential Physiological Effects. J Clin Med. 2022 Jan 29;11(3):742. doi: 10.3390/jcm11030742.

    PubMed 35160193

  • Daley J, Morrison JJ, Sather J, Hile L. The role of resuscitative endovascular balloon occlusion of the aorta (REBOA) as an adjunct to ACLS in non-traumatic cardiac arrest. Am J Emerg Med. 2017 May;35(5):731-736. doi: 10.1016/j.ajem.2017.01.010. Epub 2017 Jan 12.

    PubMed 28117180

  • Nowadly CD, Johnson MA, Hoareau GL, Manning JE, Daley JI. The use of resuscitative endovascular balloon occlusion of the aorta (REBOA) for non-traumatic cardiac arrest: A review. J Am Coll Emerg Physicians Open. 2020 Aug 30;1(5):737-743. doi: 10.1002/emp2.12241. eCollection 2020 Oct.

    PubMed 33145513

  • Hutin A, Levy Y, Lidouren F, Kohlhauer M, Carli P, Ghaleh B, Lamhaut L, Tissier R. Resuscitative endovascular balloon occlusion of the aorta vs epinephrine in the treatment of non-traumatic cardiac arrest in swine. Ann Intensive Care. 2021 May 17;11(1):81. doi: 10.1186/s13613-021-00871-z.

    PubMed 34002305

  • Kim HE, Chu SE, Jo YH, Chiang WC, Jang DH, Chang CH, Oh SH, Chen HA, Park SM, Sun JT, Lee DK. Effect of resuscitative endovascular balloon occlusion of the aorta in nontraumatic out-of-hospital cardiac arrest: a multinational, multicenter, randomized, controlled trial. Trials. 2024 Feb 13;25(1):118. doi: 10.1186/s13063-024-07928-x.

    PubMed 38347550

Questions about this trial

What is this clinical trial studying?

A study testing REBOA in people with Cardiopulmonary Arrest, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hee Eun Kim (82-31-787-7579, hekim9111@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Achieved ROSC (return of spontaneous circulation) (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06031623, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.

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