Overview

Antioxidant and NMDA Receptor Blocker Wins Anoxic Brain Damage of KorEa OHCA Patients

Status:
Unknown status

Trial end date:
2021-05-01

Target enrollment:
0

Participant gender:
All

Summary

This study aims to investigate the efficacy and safety of Neu2000KWL, a neuroprotectant, in patients resuscitated from out-of-hospital cardiac arrest and receiving therapeutic hypothermia.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

GNT Pharma

Collaborators:

Chonnam National University Hospital
Gangnam Severance Hospital
Kyungpook National University
Kyungpook National University Hospital
Pusan National University Hospital
Samsung Medical Center
Soonchunhyang University Hospital

Treatments:

Salicylates

Criteria

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