Cardiac arrest Circulatory System Cardiac arrest
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 14/02/2020: 1. Out-of-hospital cardiac arrest (OHCA) 2. Return of spontaneous circulation (ROSC) 3. Aged 18 or over (known or presumed) Previous inclusion criteria as of 27/09/2016: 1. Witnessed out-of-hospital cardiac arrest 2. Return of spontaneous circulation and 12-lead electrocardiogram 3. Age 18 or over (known or presumed) 4. No obvious non-cardiac cause (trauma, drowning, suicide, drug overdose) Previous inclusion criteria: 1. Witnessed out-of-hospital cardiac arrest 2. Absence of non-cardiac cause (trauma, drowning, intoxication) 3. Presenting rhythm: pulseless VT or VF
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 14/02/2020: 1. Criteria for ST-elevation myocardial infarction on 12-Lead electrocardiogram (ECG) 2. Do Not Attempt Resuscitation (DNAR) Order 3. Cardiac arrest suffered after care pathway set and patient en route 4. Suspected pregnancy 5. Presumed non-cardiac cause (for example; trauma, drowning, suicide, drug overdose) 6. Presumed significant trauma/injury Previous exclusion criteria as of 27/09/2016: 1. Criteria for ST-elevation myocardial infarction on 12-lead electrocardiogram 2. Do Not Attempt Resuscitation Order 3. Suspected pregnancy Previous exclusion criteria: 1. ST-elevation myocardial infarction (STEMI) on 12-lead ECG in presence of return of spontaneous circulation (ROSC) 2. Pulseless electrical activity (PEA) or Asystole (non-shockable) as the only documented rhythm 3. Do Not Attempt Resuscitation Order (DNAR) 4. Suspected pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality at 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 02/05/2023: 1. Neurological status at discharge (capped at 30 days) 2. Neurological status at 3 months 3. All-cause mortality at 3, 6 and 12 months 4. Quality of life (EQ-5D-5L) at discharge (capped at 30 days) _____ Previous secondary outcome measures as of 07/03/2023: 1. Neurological status at discharge (capped at 30 days) 2. Neurological status at 3 months 3. All-cause mortality at 3, 6 and 12 months 4. The composite of in-hospital major adverse cerebrovascular or cardiovascular events (MACCE): death, re-infarction, stroke, further revascularisation, bleeding and vascular complications (capped at 30 days) 5. Quality of life (EQ-5D-5L) at discharge (capped at 30 days) _____ Previous secondary outcome measures as of 27/09/2016: 1. Neurological status at discharge (capped at 30 days) 2. Neurological status at 3 months 3. All-cause mortality at 3, 6 and 12 months 4. The composite of in-hospital major adverse cerebrovascular or cardiovascular events (MACCE): death, re-infarction, stroke, further revascularisation, bleeding and vascular complications (capped at 30 days) 5. Quality of life (EQ-5D-5L) at 12 months _____ Previous secondary outcome measures: 1. All-cause mortality at 6 months and 1 year 2. Neurological status at hospital discharge, capped at 30 days 3. Major adverse cardiovascular events: 3.1. Acute myocardial infarction 3.2. Need for repeat revascularization: PCI or coronary artery bypass grafting (CABG) 3.3. Major bleeding: procedure-related complication (requiring surgery or drop in Hb >3g/dL) | — |
Countries
England, United Kingdom