Heart Arrest, Out-Of-Hospital Clinical Trial
— COCAOfficial title:
Calcium for Out-of-Hospital Cardiac Arrest - A Randomized, Double-Blind, Placebo-Controlled Trial
| Verified date | July 2022 |
| Source | Aarhus University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is an investigator-initiated, multicenter, randomized, placebo-controlled, parallel group, double-blind, superiority trial of calcium during adult out-of-hospital cardiac arrest. 430 adult patients with out-of-hospital cardiac arrest receiving at least one dose of adrenaline will be enrolled. The primary outcome is sustained return of spontaneous circulation and key secondary outcomes include survival at 30 days and survival at 30 days with a favorable neurological outcome.
| Status | Completed |
| Enrollment | 397 |
| Est. completion date | April 15, 2022 |
| Est. primary completion date | April 15, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Out-of-hospital cardiac arrest - Age = 18 years - Received at least one dose of adrenaline Exclusion Criteria: - Traumatic cardiac arrest - including drowning and external asphyxia (e.g., hanging, strangulation, or foreign object airway obstruction) - Known or strongly suspected pregnancy - Prior enrollment in the trial - Received adrenaline during cardiac arrest before arrival of prehospital personnel with the study drug - Clinical indication for calcium administration during the cardiac arrest |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Prehospital Emergency Medical Services | Aarhus N | Central Denmark Region |
| Lead Sponsor | Collaborator |
|---|---|
| Lars Wiuff Andersen | Central Denmark Region, University of Aarhus |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants With Sustained Return of Spontaneous Circulation | Palpable pulses or other signs of circulation without a need for chest compressions lasting at least 20 minutes. | Before or after hospital arrival (up to 2 hours after the cardiac arrest) | |
| Secondary | Number of Participants With 30-day Survival | 30 days after the cardiac arrest | ||
| Secondary | Number of Participants With 30-day Favorable Neurological Outcome | Neurological outcome will be assessed with the modified Rankin Scale (mRS) which is a scale from 0 to 6 assessing neurological/functional outcomes after brain damage with higher scores indicating worse neurological/functional outcomes. The scale will will be dichotomized as favorable (mRS 0-3) vs. unfavorable (mRS 4-6). | 30 days after the cardiac arrest |
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