A treatment for brain damage in successfully resuscitated cardiac arrest patients

A phase II double-blind randomized placebo-controlled multicenter trial to assess the efficacy and safety of Neu2000KWL for out-of-hospital cardiac arrest patient with therapeutic hypothermia

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0007235

Enrollment

150

Registered

2022-04-27

Start date

2018-11-29

Completion date

Unknown

Last updated

2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : 1) Neu2000KWL 5250mg dose group (6 doses) - 1st dose is 1500mg, 2nd to 6th dose is 750mg each, 12 hours interval for a total of 6 intravenous administration 2) Neu2000KWL 3250mg dose group (6 d

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
Verification of difference between the neuron specific enolase (NSE) value at after 4th infusion of Neu2000KWL	—

Secondary

Measure	Time frame
Verification of difference between the cumulative of neuron specific enolase (NSE) values at after 6th infusion of Neu2000KWL;Verification of the difference between groups of change in NSE values at after the 2nd infusion of Neu2000KWL and after the 6th infusion;Verification of difference between each group of NSE values at after 6th infusion of Neu2000KWL and 24 hours after the last infusion;Verification of difference between the cerebral infarction at analysis of brain MRI's Apparent Diffusion Coefficient(ADC) images within 48 hours of the last infusion of Neu2000KWL;Verification of difference between groups of Neurological function evaluated by cerebral performance category (CPC) and modified Rankin Scale (mRS) at day 5, day 14 or the date of discharge if discharged within 14 days, and day 90 after 1st infusion of Neu2000KWL.;Verification of difference between groups of Cumulative value of blood S100beta from 6th infusion after 1st infusion of Neu2000KWL.;Percentage of adverse events and serious adverse events;All mortality rate until 90 days.;Vital sign and physical examination;Laboratory test result	—

Measure

Time frame

Verification of difference between the cumulative of neuron specific enolase (NSE) values at after 6th infusion of Neu2000KWL;Verification of the difference between groups of change in NSE values at after the 2nd infusion of Neu2000KWL and after the 6th infusion;Verification of difference between each group of NSE values at after 6th infusion of Neu2000KWL and 24 hours after the last infusion;Verification of difference between the cerebral infarction at analysis of brain MRI's Apparent Diffusion Coefficient(ADC) images within 48 hours of the last infusion of Neu2000KWL;Verification of difference between groups of Neurological function evaluated by cerebral performance category (CPC) and modified Rankin Scale (mRS) at day 5, day 14 or the date of discharge if discharged within 14 days, and day 90 after 1st infusion of Neu2000KWL.;Verification of difference between groups of Cumulative value of blood S100beta from 6th infusion after 1st infusion of Neu2000KWL.;Percentage of adverse events and serious adverse events;All mortality rate until 90 days.;Vital sign and physical examination;Laboratory test result

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Countries

Korea, Republic of

Contacts

Public ContactJin-Ho Choi

Samsung Medical Center

jhchoimd@gmail.com+82-2-3410-6547

Outcome results