Not Yet RecruitingPhase 2ACTRN12623001276640

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

Sponsor

Austin Hospital

Enrollment

40 participants

Start Date

Feb 17, 2025

Study Type

Interventional

Conditions

Cardiac Arrest

Summary

Cardiac arrest is a common and catastrophic event. Among survivors of cardiac arrest, many have ongoing problems in thinking and performing normal activities of daily living. Such difficulties may arise from lack of oxygen to the brain causing injury that occurs as a result of the cardiac arrest. Therapeutic interventions that can be applied to lessen the degree of brain injury after cardiac arrest are warranted and desperately needed. Insulin-like growth factor-1 (IGF-1) is a major growth factor and has been shown to play a role in recovery from ischemic damage due to its anti-cell death signaling activity. Scp776 is a first-in-class targeted growth factor therapeutic that selectively activates and prolongs insulin-like growth factor-1 receptor (IGF-1R)-driven pro-survival signaling in damaged tissues containing large numbers of apoptotic cells. As such, by conducting a multi-centre randomsied trial, we aim to determine whether treatment with scp776, compared to placebo, decreases the extent of brain injury as calculated by automated assessment of brain magnetic resonance (MR) imaging (RAPID Software) at 72 – 96 hours following randomisation in comatose adults resuscitated after out-of-hospital cardiac arrest. This study will enrol a total of 40 evaluable participants from 5 - 10 hospitals in Victoria, Australia. The primary outcome will be ascertained between 72 - 96 hours after randomisation. Study participants will be followed-up for 180-days post-randomisation, or death, whichever is earlier.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria6

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 Criteria11

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

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Interventions

Eligible patient's will be enrolled as soon as possible after admission to hospital and within 240 minutes of return of spontaneous circulation. A registered nurse or medical doctor delegated by the site principal investigator will administer to two intravenous doses of scp776 100 mg while the participant is admitted to hospital. The first dose of scp776 must be administered within 1 hour of randomisation. The second dose of study drug should be administered at approximately the same time the following day (24 h plus or minus 30 minutes from first dose). A review of medical records will confirm the date and time of study drug administration.