Emergency Total ECLS vs Standard ACLS With ECMO Bailout for Survival in Refractory OHCA

NCT06692075 | Active Not Recruiting DMC

• 1 other identifier: N202312122
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the clinical trial is to learn if early extracorporeal life support ( ECLS ) will save more out-of-hospital cardiac arrest ( OHCA ) patients with good neurological outcome. It will also learn if emergency ECLS is safe in the OHCA rescue. Researchers aim to investigate if emergency total ECLS is better than standard advanced cardiac life support ( ACLS ) first, followed by bailout ECMO if required, for survival with favorable neurological outcome in OHCA patients. Participants meeting criteria of OHCA with witness, bystander CPR, shockable initial rhythm with repeated defibrillation, and transport time less than 30 min will be compared between total ECLS versus standard ACLS first with bailout ECMO protocols. All participants will receive emergency interventional coronary revascularization , intensive care unit therapy , cardiac ward care and up to 180 days of clinical follow up after survival .

Conditions

Out-of-hospital Cardiac Arrest (OHCA)

Keywords

out-of-hospital cardiac arrest; extracorporeal life support; advanced cardiac life support; sudden death

Outcome Measures

Primary Outcomes (1)

• The rate of survival with favorable neurological outcome ( modified Rankin score less than 3 or cerebral performance category scale 1 or 2 ) at 30 days after discharge from hospital, in percentage

  After survival discharge from hospital, clinical followup at out-patient clinic or by visual phone interview is conducted to assess medical health status as well as neurological status of the patients at 30 days after discharge from hospital. Survival with favorable neurological outcome ( i.e. modified Rankin score less than 3 or cerebral performance category scale 1 or 2 ) is to be measured as percentage of all randomized patients fulfilling inclusion criteria and without any exclusion criteria.

  From randomization to 30 days after survival discharge from hospital

Secondary Outcomes (7)

• Total duration of cardioplumonary resuscitation from on-site CPR by EMS till the stable ROSC or initiation of ECMO life support or the decease of the subject at emergency department up to 30 days after randomization, in minutes

  From the start of on-site CPR by EMS till the return of stable ROSC or the initiation of ECMO life support or the decease of the subject at the emergency department up to 30 days after randomization, in minutes

• The rate of survival with favorable neurological outcome ( modified Rankin score less than 3 or CPC scale 1 or 2 ) from the date of randomization to the date of discharge from hospital up to 180 days after randomization, in percentage

  From the date of randomization to the date of discharge from hospital up to 180 days after randomization, in percentage.

• The rate of survival with favorable outcomes ( modified Rankin score less than 3 or cerebral performance category scale 1 or 2 ) at 90 days after discharge from hospital, in percentage

  From the date of randomization to 90 days after survival discharge from hospital

• The rate of survival with favorable outcomes ( modified Rankin score less than 3 or cerebral performance category scale 1 or 2 ) at 180 days, in percentage

  From enrollment to the end of treatment at 180 days

• total duration of mechanical ventilation from randomization to discharge from hospital or up to 180 days after randomization , in days

  From randomization at the emergency department to discharge from hospital or up to 180 days after randomization

Study Arms (2)

Total ECLS in refractory OHCA

ACTIVE COMPARATOR

Emergency total extracorporeal life support ( ECLS ) in cardiopulmonary resuscitation of OHCA patients with refractory ventricular fibrillation or pulseless ventricular tachycardia

Procedure: extracorporeal life support

standard ACLS in refractory OHCA

ACTIVE COMPARATOR

Emergency standard advanced cardiac life support ( ACLS ) in cardiopulmonary resuscitation of OHCA patients with refractory ventricular fibrillation or pulseless ventricular tachycardia. Bailout ECMO allowed after at least 45 minutes of CPR since collapse and 119 call or at least 15 minutes since arrival at emergency department

Procedure: standard ACLS

Interventions

extracorporeal life support PROCEDURE

ECMO supported life support for cardiopulmonary resuscitation in refractory OHCA

Total ECLS in refractory OHCA

standard ACLS PROCEDURE

Standard ACLS in cardioplumonary resuscitation of refractory OHCA

standard ACLS in refractory OHCA

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults aged 18-75 years old
• witnessed cardiac arrest with bystander CPR
• initial shockable rhythm as ventricular fibrillation or pulseless ventricular tachycardia ( VF/pVT )
• repeated defibrillation shocks ( more than 2 ) by external defibrillator
• estimated transportation time from 119 call to arrival at emergency service less than 30 minutes.

You may not qualify if:

• age less than 18 years or more than 75 years old
• non-shockable initial rhythm, i.e. pulseless electrical activity or asystole
• acute aortic dissection
• acute massive pulmonary embolism
• intracerebral hemorrhage
• major trauma due to blunt, penetrating or burn injury
• severe peripheral artery occlusion disease
• known pregnancy
• suicide, illicit drug overdose or intoxication
• known pre-arrest modified Rankin score ( mRS ) more than 3 or cerebral performance category scale ( CPC ) more than 2
• severe concomitant malignancy with expected life expectancy less than 1 year
• signed and effective do-not-resuscitation ( DNR ) order
• absolute contraindications to emergency coronary angiography, including known anaphylactic reaction to angiographic contrast media, acute gastrointestinal bleeding or internal bleeding.

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

Study Sites (1)

Shuang Ho Hospital

New Taipei, Taiwan, 23561, Taiwan

Location

Related Publications (1)

• Fu HY, Liu YH, Li SJ, Chang HC, Liu CC, Lee CM, Huang CY, Hsu CW, Ko CI, Wang YC, Chang WT, Wang TJ, Ong JR, Sun JT, Chen JS, Hsu CY, Jang SJ, Chen YL, Lin YH, Chien CY, Kung YC, Wang TL, Yu HC, Hsu CC, Chao CC, Chen CW, Hsu CY, Hsu SC, Chang TI, Yeh JS, Tsai MS, Wei LY, Chou HW, Wang CH, Chang CH, Chen CL, Tu YK, Lin JL, Chen YS. Emergency total extracorporeal life support versus standard advanced cardiac life support with rescue extracorporeal membrane oxygenation for refractory out-of-hospital cardiac arrest: protocol for the ECLS-OHCA randomized trial. Scand J Trauma Resusc Emerg Med. 2026 Feb 3. doi: 10.1186/s13049-026-01557-w. Online ahead of print.

  PMID: 41630056 DERIVED

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest; Death, Sudden

Interventions

Extracorporeal Membrane Oxygenation

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Therapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Data and Safety Monitoring Committee
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two arms are designed. One is the total ECLS arm to start emergency ECMO supported cardiopulmonary resuscitation immediately after the arrival of eligible OHCA patients at the emergency department. The other is the standard ACLS arm to start standard ACLS cardiopulmonary resuscitation for at least 45 minutes from collapse and 119 call or at least 15 minutes after arrival at the emergency department.

Study Record Dates

• First Submitted: September 15, 2024
• First Posted: November 18, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: May 18, 2025

Record last verified: 2024-09

Locations

TW (1)