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REBOA in Nontraumatic OHCA

ConditionCardiopulmonary Arrest
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorSeoul National University Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult nontraumatic OHCA

Witnessed arrest

Arrival at ER from 9AM to 5PM (in South Korea) and 8AM to 8PM (in Taiwan)

Disqualifiers

age below 20 years old or over 80 years old,

traumatic cardiac arrest,

those with unwitnessed cardiac arrest,

pregnant patients,

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

234 Participants
are divided into 2 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: REBOAExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Number of patients who achieves ROSC regardless of sustained time

Time frame
24 hours

Secondary outcomes

1

Number of Participants Who Achieved Sustained ROSC

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

Time frame
24 hours
2

Survival to Admission

Whether patients who achieve sustained ROSC survives until admission

Time frame
48 hours
3

Survival to Discharge

Whether patients survive until hospital discharge.

Time frame
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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seoul National University Hospital

Lead sponsor

Far Eastern Memorial Hospital

Collaborator

Source ClinicalTrials.gov
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