MedTrace Logo

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

NCT03651557 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2019-03-06

No results posted yet for this study

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.

Conditions

  • Cardiac Arrest

Interventions

DRUG

Neu2000KWL High-dose group

1st infusion of 1500mg in patients within 4 hours following sudden cardiac arrest onset followed by 5 consecutive infusions of 750 mg at intervals of 12 hours(Total drug dosage is 5250mg.)

DRUG

Neu2000KWL Low-dose group

1st infusion of 750mg in patients within 4 hours following sudden cardiac arrest onset followed by 5 consecutive infusions of 500 mg at intervals of 12 hours (Total drug dosage is 3250mg.)

DRUG

Placebo

1st infusion of the same volume of saline in patients within 4 hours following sudden cardiac arrest onset followed by 5 consecutive infusions of the same volume of saline at intervals of 12 hours

Sponsors & Collaborators

  • Samsung Medical Center

    collaborator OTHER

  • Chonnam National University Hospital

    collaborator OTHER

  • Gangnam Severance Hospital

    collaborator OTHER

  • Kyungpook National University Hospital

    collaborator OTHER

  • Pusan National University Hospital

    collaborator OTHER

  • Soonchunhyang University Hospital

    collaborator OTHER

  • GNT Pharma

    lead INDUSTRY

Principal Investigators

  • Jin-Ho Choi, MD · Professor, Department of Emergency Medicine, Samsung Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-29
Primary Completion
2021-05-31
Completion
2021-05-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03651557 on ClinicalTrials.gov