We aim to investigate ECPR in a prospective manner since earlier retrospective studies have suggested that application of ECPR during refractory arrest increases the chance of survival and decreases neurological damage. In a randomized, multi-center…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
30-days survival rate with favourable neurological status (Cerebral Performance
Category (CPC) score of 1 or 2)
Secondary outcome
neurological outcome at 3 months, 6 months and 12 months, survival benefit
(Quality Adjusted Life Years, QALY), costs per QALY
Background summary
Chances of survival in case of out-of-hospital cardiac arrest (OHCA) are small.
After 15 minutes of resuscitation survival declines sharply. In case of
ventricular fibrillation/tachycardia (VF/VT) there is often a treatable
underlying cause. During resuscitation however, diagnostic and therapeutic
options are severely limited. With the use of extracorporeal cardiopulmonary
resuscitation (ECPR) can circulation be restored, gaining precious time to
diagnose and treat the underlying problem. Current data on this subject is
retrospective and non-randomized, but a possible benefit is suggested.
Study objective
We aim to investigate ECPR in a prospective manner since earlier retrospective
studies have suggested that application of ECPR during refractory arrest
increases the chance of survival and decreases neurological damage. In a
randomized, multi-center trial it can also be examined whether routine use of
ECPR in refractory cardiac arrest can be economically justified by performing a
cost-effectiveness analysis.
Study design
Randomized controlled multi-center trial
Intervention
Patients will be randomized to either receive ECPR or continued conventional
CPR (CCPR).
Study burden and risks
The chances of survival with good neurological outcome of a refractory OHCA due
to VF/VT are small. Performing ECPR on these patients may substantially
increase their chances on survival with a good neurological outcome as
suggested by retrospective research. ECPR does have high risks associated with
the treatment itself, e.g. bleeding, infection, ischemia of a leg, thrombosis,
cannula displacement and circuit failure. However, the potential increase in
chances of survival with good neurologic outcome is large enough to accept
these risks.
Thirty days, three months, six months and twelve months after the OHCA the
patients or their families will be asked to fill in questionnaires to assess
their neurological status and several patient related outcome measures. Apart
from these questionares there is no additional burden associated with
participation.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
- ventricular fibrilation
- <=70 years
- >=18 years
- > 15 minutes no circulation
- whitnessed out-of-hospital cardiac arrest
- Bystander BLS
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT03101787 |
| CCMO | NL58067.068.16 |