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Totale ECLS voor noodgevallen versus standaard ACLS met ECMO-bailout voor overleving in refractaire OHCA (ECLS-OHCA)

4 november 2026 bijgewerkt door: Taipei Medical University Shuang Ho Hospital

Totale extracorporale levensondersteuning bij noodgevallen versus standaard geavanceerde cardiale levensondersteuning met ECMO reddingsoperatie voor overleving met gunstige neurologische uitkomst bij refractaire hartstilstand buiten het ziekenhuis

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 .

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Out-of-hospital cardiac arrest ( OHCA ) is a highly lethal emergency, unless return of spontaneous circulation ( ROSC ) is timely achieved by efficient and effective resuscitation. Nevertheless, despite advanced cardiopulmonary resuscitation ( CPR ) with mechanical chest compression, assisted ventilation and automatic external defibrillation, the survival of OHCA patients remains below 10%. Extracorporeal membranous oxygenation ( ECMO ) facilitated life support ( ECLS ) could help hemodynamic stability and improve significantly the survival of refractory OHCA to 25-40 %. On the other hand, the precise role and timing of the ECLS during the emergency management of OHCA remains largely unestablished.

In the present study, we hypothesized that emergency total ECLS is superior to standard ACLS with ECMO bailout for survival with favorable neurological outcome in refractory out-of-hospital cardiac arrest. All OHCA patients meeting the including criteria, i.e. age 18-75 years, witnessed cardiac arrest with bystander CPR, initial shockable rhythm as ventricular fibrillation or pulseless ventricular tachycardia ( VF/pVT ), repeated defibrillation shocks and escorted transportation within 30 minutes from 119 call to arriving emergency department ( ED ) in the hospital would be recruited. Eligible patients will be consecutively randomized at ED in 1:1 ratio, stratified by hospitals, into emergency total ECLS group and standard ACLS with ECMO bailout group. Informed consent is waived in the life-threatening emergency condition. For emergency total ECLS group, OHCA patients will receive early implantation and initiation of ECMO circulation within 15 minutes after randomization or up to 45 minutes after 119 call. For standard ACLS with ECMO bailout group, OHCA patients will receive standard ACLS for at least 45 minutes after collapse or 119 call or at least 15 minutes after ED arrival before calling for bailout ECMO if required. Following return of spontaneous systemic circulation (ROSC) or depending on ECMO circulation, both groups would be transferred to brain and chest computer tomography screening, emergency coronary revascularization intervention and subsequent intensive cardiac care with targeted hypothermia management. Survivals will be treated with guideline directed medical therapy for reduced ejection fraction heart failure and/or implantable cardioverter-defibrillator implantation for prevention of recurrent VT/VF in wards. All survivals will be followed up for medical and neurological status at 30 days, 90 days and 180 days after discharge.

Primary endpoint is survival with favorable neurological outcome at 30 days. Secondary endpoints are survival to discharge with favorable neurological outcome, survival with favorable neurological outcome at 180 days, total duration of cardiopulmonary resuscitation ( CPR ), total duration of mechanical ventilation, total duration of intensive care unit stay, total duration of hospitalization. Safety endpoints will be incidence of serious adverse events related to prolonged CPR, prolonged ischemia, and ECMO systemic perfusion and coronary reperfusion.

The number of subjects to be enrolled according to the primary endpoint of 30 days survival with favorable neurological outcome. With a power of 80%, accepting the level of statistical significance at alpha= 0.05 and based on two-sided Chi-Square test, we estimated 166 participants per arm are needed. This is based on the 30% success rate and 15% success rate of 30-day survival with good neurological outcome of emergency total ECLS intervention and standard ACLS with bailout ECMO (if required) intervention, according to previous trials, plus a 10% drop out rate. Based on two-tailed test, p less than 0.05 is considered statistical significance. If interim analysis is deemed necessary, the significance level will be adjusted accordingly using Bonferroni method. Because of no interim analysis and no stopping point in ITT protocol, there is no criteria for premature termination of the trial. The missing data of the primary and secondary efficacy outcomes will be considered as failure for ITT analysis. Last observations carry forward method will be adapted for the missing data of repeated measurements. The data record will be monitored and audited by the Institutional Review Board of the TMU Shuangho hospital as well as the Data and Safety Monitoring Plan committee.

Studietype

Ingrijpend

Inschrijving (Geschat)

332

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Taiwan
    • Taiwan
      • New Taipei, Taiwan, Taiwan, 23561
        • Werving
        • Shuang Ho Hospital
        • Contact:
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Jiunn-Lee Lin, MD PHD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 75 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

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

Exclusion Criteria:

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Total ECLS in refractory OHCA

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

ECMO supported life support for cardiopulmonary resuscitation in refractory OHCA
Actieve vergelijker: standard ACLS in refractory OHCA

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

Standard ACLS in cardioplumonary resuscitation of refractory OHCA

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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
Tijdsspanne: From randomization to 30 days after survival discharge from hospital

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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
Tijdsspanne: 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

total duration of standard cardiopulmonary resuscitation ( CPR ) is counted from the start of on-site CPR by emergency medical service ( EMS ) till the stable return of spontaneous circulation ( ROSC ) or initiation of ECMO life support or the decease of the subject at emergency department ( ED ) up to 30 days after randomization. The measure is 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
Tijdsspanne: From the date of randomization to the date of discharge from hospital up to 180 days after randomization, in percentage.

At discharge from hospital, patient status is assessed as survival or mortality. The rate of survival with favorable neurological outcome ( modified Rankin score <3 or CPC scale 1 or 2 ) is counted from the date of randomization to the date of discharge from hospital up to 180 days after randomization. The rate of survival is measured as percentage of total randomization number.
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
Tijdsspanne: From the date of randomization to 90 days after survival discharge from hospital

After patients survived and discharged from hospital, clinical followup at out-patient clinic or by visual phone interview is conducted to assess medical health as well as neurological status at 90 days after discharge. The rate of survival with favorable neurological outcome ( i.e. modified Rankin score less than 3 or cerebral performance category scale 1 or 2 ) is measured as percentage of all randomized patients fulfilling inclusion criteria and without any exclusion criteria.
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
Tijdsspanne: From enrollment to the end of treatment at 180 days

After patients discharged from hospital, clinical followup at out-patient clinic or by visual phone interview is conducted to assess medical health as well as neurological status at 180 days after discharge. The rate of survival with favorable neurological outcome ( i.e. modified Rankin score less than 3 or cerebral performance category scale 1 or 2 ) is measured as percentage of all enrolled patients fulfilling inclusion criteria and without any exclusion criteria.
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
Tijdsspanne: From randomization at the emergency department to discharge from hospital or up to 180 days after randomization

The total duration of assisted mechanical ventilation by volume cycle or pressure cycled artificial ventilators from randomization at the emergency department to discharge from hospital or up to 180 days after randomization, measured in days.
From randomization at the emergency department to discharge from hospital or up to 180 days after randomization
total duration of stay in intensive care ward from randomization to discharge from hospital or up to 180 days after randomization , in days
Tijdsspanne: From the date of randomization to the date of discharge from hospital or up to 180 days after randomization

The total duration of stay in intensive care ward from randomization to discharge from hospital or up to 180 days after randomization. The intensive care ward is to provide cardiovascular hemodynamic support, assisted mechanical ventilation, targeted temperature therapy ( if needed ) and infection control, whenever needed. The measure is in days.
From the date of randomization to the date of discharge from hospital or up to 180 days after randomization
total duration of hospitalization from the date of randomization to the date of discharge or up to 180 days after randomization , in days
Tijdsspanne: From the date of randomization to the date of discharge from hospital or up to 180 days after randomization, survived or deceased.

total duration of stay in the hospital from the date randomization at emergency department to the date discharge from hospital or up to 180 days after randomization, survived or deceased. The measure in in days.
From the date of randomization to the date of discharge from hospital or up to 180 days after randomization, survived or deceased.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Taipei Medical University Shuang Ho Hospital

Medewerkers

National Taiwan University Hospital
Mackay Memorial Hospital
Taipei Medical University Hospital
Far Eastern Memorial Hospital
Taipei Medical University WanFang Hospital
Taichung Tzu Chi Hospital
Fu Jen Catholic University Hospital
Taipei Hospital, Taiwan
Chiba University Hospital, Japan

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 november 2024

Primaire voltooiing (Geschat)

1 november 2028

Studie voltooiing (Geschat)

1 juli 2029

Studieregistratiedata

Eerst ingediend

15 september 2024

Eerst ingediend dat voldeed aan de QC-criteria

15 november 2024

Eerst geplaatst (Werkelijk)

18 november 2024

Updates van studierecords

Laatste update geplaatst (Werkelijk)

9 november 2026

Laatste update ingediend die voldeed aan QC-criteria

4 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • N202312122

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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