NCT06031623

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
234

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Oct 2023Oct 2026

First Submitted

Initial submission to the registry

September 2, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 11, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

October 17, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

January 28, 2025

Status Verified

January 1, 2025

Enrollment Period

2 years

First QC Date

September 2, 2023

Last Update Submit

January 24, 2025

Conditions

Cardiopulmonary Arrest

Keywords

Advanced cardiopulmonary resuscitation (ACLS)Cardiopulmonary resuscitation (CPR)Resuscitative endovascular balloon occlusion of the aorta (REBOA)

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Achieved ROSC (return of spontaneous circulation)

    Number of patients who achieves ROSC regardless of sustained time

    24 hours

Secondary Outcomes (5)

  • Number of Participants Who Achieved Sustained ROSC

    24 hours

  • Survival to Admission

    48 hours

  • Survival to Discharge

    30 days

  • Neurological Outcome

    1 month, 3 months, 6 months since ROSC

  • Changes in Arterial Blood Pressure

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

Study Arms (2)

Control

NO INTERVENTION

Patients allocated to this arm receives conventional resuscitative measures according to the 2020 AHA CPR Guidelines.

REBOA

EXPERIMENTAL

After 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.

Device: REBOA

Interventions

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.

REBOA

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National Univeristy Bundang Hospital

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

RECRUITING

Related Publications (7)

  • 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.

    PMID: 35870557BACKGROUND

  • 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.

    PMID: 31707942BACKGROUND

  • 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.

    PMID: 35160193BACKGROUND

  • 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.

    PMID: 28117180BACKGROUND

  • 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.

    PMID: 33145513BACKGROUND

  • 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.

    PMID: 34002305BACKGROUND

  • 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.

    PMID: 38347550DERIVED

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Hee Eun Kim

CONTACT

82-31-787-7579hekim9111@gmail.com

Dong Hyun Jang

CONTACT

82-31-787-7819jang0621@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

September 2, 2023

First Posted

September 11, 2023

Study Start

October 17, 2023

Primary Completion

October 1, 2025

Study Completion (Estimated)

October 1, 2026

Last Updated

January 28, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)