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Calcium for Out-of-Hospital Cardiac Arrest (COCA)

Primary Purpose

Heart Arrest, Out-Of-Hospital

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Calcium Chloride
Sodium chloride 0.9%
Sponsored by
Lars Wiuff Andersen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Arrest, Out-Of-Hospital

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Prehospital Emergency Medical Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Calcium

Placebo

Arm Description

The intervention will consist of 5 mmol (10 mL ampoule) of calcium chloride (CaCl2) administered intravenously or intraosseously immediately after the first dose of adrenaline and again after the second dose of adrenaline.

The placebo will consist of 10 mL of 9 mg/mL sodium chloride (NaCl, "normal saline") administered intravenously or intraosseously immediately after the first dose of adrenaline and again after the second dose of adrenaline.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Participants With 30-day Survival
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).

Full Information

First Posted
November 3, 2019
Last Updated
July 18, 2022
Sponsor
Lars Wiuff Andersen
Collaborators
Central Denmark Region, University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT04153435
Brief Title
Calcium for Out-of-Hospital Cardiac Arrest
Acronym
COCA
Official Title
Calcium for Out-of-Hospital Cardiac Arrest - A Randomized, Double-Blind, Placebo-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 20, 2020 (Actual)
Primary Completion Date
April 15, 2021 (Actual)
Study Completion Date
April 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lars Wiuff Andersen
Collaborators
Central Denmark Region, University of Aarhus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Arrest, Out-Of-Hospital

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
397 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Calcium
Arm Type
Experimental
Arm Description
The intervention will consist of 5 mmol (10 mL ampoule) of calcium chloride (CaCl2) administered intravenously or intraosseously immediately after the first dose of adrenaline and again after the second dose of adrenaline.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The placebo will consist of 10 mL of 9 mg/mL sodium chloride (NaCl, "normal saline") administered intravenously or intraosseously immediately after the first dose of adrenaline and again after the second dose of adrenaline.
Intervention Type
Drug
Intervention Name(s)
Calcium Chloride
Other Intervention Name(s)
CaCl2
Intervention Description
Calcium chloride 5 mmol
Intervention Type
Drug
Intervention Name(s)
Sodium chloride 0.9%
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Number of Participants With Sustained Return of Spontaneous Circulation
Description
Palpable pulses or other signs of circulation without a need for chest compressions lasting at least 20 minutes.
Time Frame
Before or after hospital arrival (up to 2 hours after the cardiac arrest)
Secondary Outcome Measure Information:
Title
Number of Participants With 30-day Survival
Time Frame
30 days after the cardiac arrest
Title
Number of Participants With 30-day Favorable Neurological Outcome
Description
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).
Time Frame
30 days after the cardiac arrest

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars W Andersen
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prehospital Emergency Medical Services
City
Aarhus N
State/Province
Central Denmark Region
ZIP/Postal Code
8200
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Six months after the publication of the last results, all deidentified individual patient data will be made available for data sharing. Procedures, including re-coding of key variables, will be put in place to allow for complete deidentification of the data. Data will be completely anonymized according to Danish law.
IPD Sharing Time Frame
Six months after the publication of the last results
IPD Sharing Access Criteria
Data will be available for any research purpose to all interested parties who have approval from an independent review committee and who have a methodological sound proposal as determined by the steering committee of the current trial. Only the methodological qualities and not the purpose or objective of the proposal will be considered.
Citations:
PubMed Identifier
35917866
Citation
Vallentin MF, Granfeldt A, Meilandt C, Povlsen AL, Sindberg B, Holmberg MJ, Iversen BN, Maerkedahl R, Mortensen LR, Nyboe R, Vandborg MP, Tarpgaard M, Runge C, Christiansen CF, Dissing TH, Terkelsen CJ, Christensen S, Kirkegaard H, Andersen LW. Effect of calcium vs. placebo on long-term outcomes in patients with out-of-hospital cardiac arrest. Resuscitation. 2022 Oct;179:21-24. doi: 10.1016/j.resuscitation.2022.07.034. Epub 2022 Jul 30.
Results Reference
derived
PubMed Identifier
34847226
Citation
Vallentin MF, Granfeldt A, Meilandt C, Povlsen AL, Sindberg B, Holmberg MJ, Iversen BN, Maerkedahl R, Mortensen LR, Nyboe R, Vandborg MP, Tarpgaard M, Runge C, Christiansen CF, Dissing TH, Terkelsen CJ, Christensen S, Kirkegaard H, Andersen LW. Effect of Intravenous or Intraosseous Calcium vs Saline on Return of Spontaneous Circulation in Adults With Out-of-Hospital Cardiac Arrest: A Randomized Clinical Trial. JAMA. 2021 Dec 14;326(22):2268-2276. doi: 10.1001/jama.2021.20929.
Results Reference
derived
Links:
URL
http://www.cocatrial.dk
Description
Trial website

Learn more about this trial

Calcium for Out-of-Hospital Cardiac Arrest

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