UnknownPhase 2

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

South Korea150 participantsStarted 2018-11-29

Plain-language 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.

Who can participate

Age range19 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

✕. Hypersensitivity to aspirin or sulfasalazine
✕. Unwitnessed cardiac arrest
✕. CPR time \> 60 min
✕. Therapeutic hypothermia is not planned
✕. Use of extracorporeal membrane oxygenation (ECMO) at initiation of in-hospital resuscitation (E-CPR)
✕. 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
✕. Pregnant or lactating women
✕. Participated in other clinical studies within 90 days before randomization; or participating in other clinical trials at present

What they're measuring

Verification of difference between of Neuron specific enolase (NSE) value at after 4th infusion of Neu2000KWL.

Timeframe: The 3rd day of study (which corresponds to finished 4th infusion of Neu2000KWL).

Trial details

NCT IDNCT03651557

SponsorGNT Pharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-05

View on ClinicalTrials.gov More Cardiac Arrest trials