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Trial record 1 of 1 for:    NCT04153435
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Calcium for Out-of-Hospital Cardiac Arrest (COCA)

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ClinicalTrials.gov Identifier: NCT04153435
Recruitment Status : Completed
First Posted : November 6, 2019
Results First Posted : February 25, 2022
Last Update Posted : July 25, 2022
Sponsor:
Collaborators:
Central Denmark Region
University of Aarhus
Information provided by (Responsible Party):
Lars Wiuff Andersen, Aarhus University Hospital

Tracking Information
First Submitted Date  ICMJE November 3, 2019
First Posted Date  ICMJE November 6, 2019
Results First Submitted Date  ICMJE January 11, 2022
Results First Posted Date  ICMJE February 25, 2022
Last Update Posted Date July 25, 2022
Actual Study Start Date  ICMJE January 20, 2020
Actual Primary Completion Date April 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2022)
Number of Participants With Sustained Return of Spontaneous Circulation [ Time Frame: Before or after hospital arrival (up to 2 hours after the cardiac arrest) ]
Palpable pulses or other signs of circulation without a need for chest compressions lasting at least 20 minutes.
Original Primary Outcome Measures  ICMJE
 (submitted: November 5, 2019)
Return of spontaneous circulation at hospital arrival [ Time Frame: At hospital arrival (up to 2 hours after the cardiac arrest) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2022)
  • Number of Participants With 30-day Survival [ Time Frame: 30 days after the cardiac arrest ]
  • Number of Participants With 30-day Favorable Neurological Outcome [ Time Frame: 30 days after the cardiac arrest ]
    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).
Original Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2019)
  • Survival [ Time Frame: 30 days after the cardiac arrest ]
  • Favorable neurological outcome [ Time Frame: 30 days after the cardiac arrest ]
    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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Calcium for Out-of-Hospital Cardiac Arrest
Official Title  ICMJE Calcium for Out-of-Hospital Cardiac Arrest - A Randomized, Double-Blind, Placebo-Controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Heart Arrest, Out-Of-Hospital
Intervention  ICMJE
  • Drug: Calcium Chloride
    Calcium chloride 5 mmol
    Other Name: CaCl2
  • Drug: Sodium chloride 0.9%
    Placebo
Study Arms  ICMJE
  • Experimental: Calcium
    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.
    Intervention: Drug: Calcium Chloride
  • Placebo Comparator: Placebo
    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: Drug: Sodium chloride 0.9%
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 11, 2022)
397
Original Estimated Enrollment  ICMJE
 (submitted: November 5, 2019)
430
Actual Study Completion Date  ICMJE April 15, 2022
Actual Primary Completion Date April 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04153435
Other Study ID Numbers  ICMJE 00002
2019-003387-46 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Analytic Code
Time Frame: Six months after the publication of the last results
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.
Current Responsible Party Lars Wiuff Andersen, Aarhus University Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Lars Wiuff Andersen
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Central Denmark Region
  • University of Aarhus
Investigators  ICMJE
Principal Investigator: Lars W Andersen Aarhus University Hospital
PRS Account Aarhus University Hospital
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP