A Pilot, Safety, Efficacy and Feasibility Double-Blind Randomised Controlled Trial of Scp776 for Neuroprotection in Comatose Adults Resuscitated After Out-of-Hospital Cardiac Arrest

Phase 2

• Conditions: Cardiac Arrest; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12623001276640
• Lead Sponsor: Austin Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-12-07
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Adult age equal to or greater than 18 years of age
Out-of-hospital cardiac arrest of a presumed cardiac or unknown cause
Sustained return of spontaneous circulation defined as 20 minutes with signs of circulation without the need for chest compressions.
Unconscious defined as a FOUR-score motor response of less than 4 which is not able to obey verbal commands after sustained return of spontaneous circulation
Eligible for intensive care without restrictions or limitations
Within 240 minutes of return of spontaneous circulation

Exclusion Criteria

Unwitnessed cardiac arrest with an initial rhythm of asystole
Temperature on admission less than 30 degrees Celsius
On extracorporeal membrane oxygenation prior to return of spontaneous circulation
Obvious or suspected pregnancy
Severe hypoglycemia defined as a serum glucose level of less than 60 mg per deciliter
Patients receiving more than 0.5 mcg per kilogram per minute of norepinephrine equivalent
Patient with severe active haemorrhage
Known or suspected metal implants that would preclude the ability to tolerate a magnetic resonance imaging scan.
Patients residing in a nursing home.
Patients having a reported weight of less than 50 kilograms
Previously enrolled into the PROSPER trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Volume of brain injury between the scp776 group and the placebo group as calculated by automated assessment of brain magnetic resonance imaging.[As calculated by automated assessment of brain magnetic resonance imaging scan data. Brain magnetic resonance imaging is to be performed between 72 – 96 hours following randomisation and data extracted from the patients electronic medical record.]