A treatment for brain damage in successfully resuscitated cardiac arrest patients

Not Applicable

Recruiting

• Conditions: Diseases of the circulatory system

• Registration Number: KCT0007235
• Lead Sponsor: GNT Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 2 May 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1) 19 Years to 80 Years (Adult)
2) Out-of-hospital cardiac arrest caused by non-perfusing cardiac rhythm
3) Successful resuscitation accompanied by ROSC time of more than 20 min
4) Therapeutic hypothermia is planned or initiated
5) The first infusion is planned within 4 hours after ROSC
6) Informed consent is obtained from patient or family member(s)
7) No concern with previous cardiovascular surgery

Exclusion Criteria

1) Hypersensitivity to aspirin or sulfasalazine
2) Unwitnessed cardiac arrest
3) CPR time > 60 min
4) Therapeutic hypothermia is not planned
5) Use of extracorporeal membrane oxygenation (ECMO) at initiation of in-hospital resuscitation (E-CPR)
6) Very poor prognosis is expected: patients with (A) non-cardiac or respiratory arrest, (B) poor basal neurological status (C) secondary cardiac arrest caused by trauma, major bleeding, acute neurologic disease including stroke or tumor, (D) multiorgan failure or advanced malignancy
7) Pregnant or lactating women
8) Participated in other clinical studies within 90 days before randomization; or participating in other clinical trials at present
9) Intracranial bleeding verified by first brain CT imaging
10) The investigators consider the patients are not suitable for this trial

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Verification of difference between the neuron specific enolase (NSE) value at after 4th infusion of Neu2000KW