Administration of calcium during cardiac arrest outside the hospital

Calcium for Out-of-Hospital Cardiac Arrest – A Randomized, Double-Blind, Placebo-Controlled trial - COCA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003387-46-DK

Enrollment

674

Registered

2019-09-19

Start date

2019-10-28

Completion date

Unknown

Last updated

2021-06-14

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

Conditions

The study will include patients with out-of-hospital cardiac arrest (OHCA). The study will test whether treatment with Calcium Chloride added to standard care will improve survival following OHCA. The study is a double blind placebo controlled trial. MedDRA version: 20.0 Level: LLT Classification code 10007517 Term: Cardiac arrest transient System Organ Class: 100000004849

Interventions

Trade Name: Calcium Chloride Product Name: Calcium Chloride Pharmaceutical Form: Solution for injection INN or Proposed INN: Calcium Chloride Other descriptive name: CALCIUM CHLORIDE Concentration uni

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) OHCA 2) Age = 18 years 3) Received at least one dose of adrenaline during CPR Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 204 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 470

Exclusion criteria

Exclusion criteria: 1) Traumatic OHCA 2) Known or strongly suspected pregnancy 3) Prior enrollment in the trial 4) Already received one dose of adrenaline by a non-participating unit 5) Clinical indication for calcium administration during the cardiac arrest

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether calcium administration during adult OHCA will improve return of spontaneous circulation.;Secondary Objective: To determine whether calcium administration during adult OHCA will increase survival at 30 days and survival at 30 days with a favorable neurological outcome (modified Rankin Scale, mRS) ;Primary end point(s): The primary outcome, return of spontaneous circulation (ROSC), has been updated to "sustained ROSC". ROSC is defined as palpable pulses or other signs of circulation without a need for chest compressions. Sustained ROSC means that the patient withholds ROSC >20 min. These definitions were made before the initiation of the trial and were included in the first version of the data dictionary (time stamp: January 21st 2020).;Timepoint(s) of evaluation of this end point: The endpoint is evaluated during ongoing cardiopulmonary resuscitation	—

Measure

Time frame

Main Objective: To determine whether calcium administration during adult OHCA will improve return of spontaneous circulation.;Secondary Objective: To determine whether calcium administration during adult OHCA will increase survival at 30 days and survival at 30 days with a favorable neurological outcome (modified Rankin Scale, mRS) ;Primary end point(s): The primary outcome, return of spontaneous circulation (ROSC), has been updated to "sustained ROSC". ROSC is defined as palpable pulses or other signs of circulation without a need for chest compressions. Sustained ROSC means that the patient withholds ROSC >20 min. These definitions were made before the initiation of the trial and were included in the first version of the data dictionary (time stamp: January 21st 2020).;Timepoint(s) of evaluation of this end point: The endpoint is evaluated during ongoing cardiopulmonary resuscitation

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Secondary

Measure	Time frame
Secondary end point(s): Key secondary outcomes will include survival as well as neurological outcome at 30 days. Neurological outcome will be assessed with the modified Rankin Scale (mRS); scores 0-6 will be presented as counts and percentages, while the outcome will be dichotomized as favorable (mRS 0-3) vs. unfavorable (mRS 4-6).;Timepoint(s) of evaluation of this end point: 30 days after the cardiac arrest	—

Measure

Time frame

Secondary end point(s): Key secondary outcomes will include survival as well as neurological outcome at 30 days. Neurological outcome will be assessed with the modified Rankin Scale (mRS); scores 0-6 will be presented as counts and percentages, while the outcome will be dichotomized as favorable (mRS 0-3) vs. unfavorable (mRS 4-6).;Timepoint(s) of evaluation of this end point: 30 days after the cardiac arrest

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Countries

Denmark

Contacts

Public ContactLars Wiuff Andersen

Research Center for Emergency Medicine Department of Clinical Medicine Aarhus University

lwandersen@clin.au.dk004551781511

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026