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 range

19 Years – 80 Years

Sex

ALL

See this in plain English?

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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