CYclosporine A in Shockable Out-of-hospital Cardiac Arrest ResUScitation

Phase 3

Withdrawn

• Conditions: Shockable Out of Hospital Cardiac Arrest
• Interventions: Drug: Single intravenous bolus of cyclosporine A (2.5 mg/kg) at the onset of resuscitation; Drug: Single intravenous bolus of placebo at the onset of resuscitation

• Registration Number: NCT02887807
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Cardiac arrest (CA) is a public health problem in industrialized countries. The prognosis of these patients remains poor with significant mortality and severe neurological sequelae in survivors.

The objective of the present study is to determine whether cyclosporine can improve patient clinical outcome after shockable CA. 520 patients with CA will be entered into a multicentre, randomized, placebo-controlled study. They will receive one single injection of cyclosporine (or placebo) prior to resuscitation. The incidence of the combined endpoint (mortality, irreversible brain damage informations such as bilateral abolition of N20 wave or absent motor response or extension to the nociceptive stimulation...) will be assessed 7 days after CA.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-18
• Study First Submitted QC: 2016-08-29
• Study First Posted: 2016-09-02
• Study Start: 2017-01
• Primary Completion: 2019-01
• Study Completion: 2019-01
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-13
• Last Update Posted: 2019-03-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Witnessed out-of-hospital cardiac arrest
• Shockable cardiac rhythm at first medical contact (ventricular fibrillation, ventricular tachycardia)

Read More

Exclusion Criteria

• Evidence of trauma
• Evidence of pregnancy
• Duration of no flow more than 30 minutes
• Rapidly fatal underlying disease
• Allergy to cyclosporin A

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cyclosporine A	Single intravenous bolus of cyclosporine A (2.5 mg/kg) at the onset of resuscitation	Single intravenous bolus of cyclosporine A (2.5 mg/kg) at the onset of resuscitation
Control	Single intravenous bolus of placebo at the onset of resuscitation	Single intravenous bolus of placebo (2.5 mg/kg) at the onset of resuscitation

Primary Outcome Measures

Name	Time	Method
Combined incidence of all-cause mortality and irreversible brain damage status	7 days	the presence of irreversible brain damage is defined by the bilateral abolition of the N20 wave on somatosensory evoked potentials recordings or the absence of motor response or extension to painful stimuli on the Glasgow Coma Scale.

Trial Locations

Locations (1)

Hopital Cardiologique; 🇫🇷 Bron, France