The COCA trial is a randomized, double-blind, placebo-controlled trial evaluating calcium chloride (CaCl) as an intra-arrest intervention for patients with out-of-hospital cardiac arrest (see Interventions). The flow chart on the right provides an overview of the condition, standard basic care, the intervention as well as the primary and secondary outcomes.
This trial includes unconscious patients that are unable to provide informed consent. Given the urgency of the intervention, it is not possible to obtain consent from a surrogate (e.g. family member). The trial is therefore conducted under the regulation of an “acute study” in accordance with Danish law with the use of an independent “legal guardian” for consent. As soon as possible, consent for future data collection will be obtained from the patient or a surrogate.
The trial has been approved by the Regional Ethics Committee of Central Denmark Region as well as the Danish Medicines Agency.