Early initiation of extracorporeal life support in refractory out-of-hospital cardiac arrest

Early initiation of extracorporeal life support in refractory out-of-hospital cardiac arrest - INCEPTION trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55387

Enrollment

134

Registered

2017-03-01

Start date

2017-05-18

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac arrest

Interventions

Patients will be randomized to either receive ECPR or continued conventional CPR (CCPR).

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - ventricular fibrilation - =18 years - > 15 minutes no circulation - whitnessed out-of-hospital cardiac arrest - Bystander BLS

Exclusion criteria

Exclusion criteria: - ROSC within 15 minutes of conventional CPR with sustained hemodynamic recovery - Terminal heart failure (NYHA III or IV) - Severe pulmonary disease (COPD GIII of GIV) - Disseminated oncological disease - Obvious or suspected pregnancy - Bilateral femoral bypass surgery - Known contraindications for ECPR - Known pre-arrest Cerebral Performance Category 3 or 4 - Known limitations in therapy or a Do Not Resuscitate-order - Multi-trauma (Injury Severity Score >15) - > 60 minutes before start cannulation procedure

Design outcomes

Primary

Measure	Time frame
30-days survival rate with favourable neurological status (Cerebral Performance Category (CPC) score of 1 or 2)	—

Secondary

Measure	Time frame
neurological outcome at 3 months, 6 months and 12 months, survival benefit (Quality Adjusted Life Years, QALY), costs per QALY	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)