NCT03345706

Brief Summary

The study is designed as a pilot, open-label study to investigate the feasibility and safety of selective cerebral hypothermia in OHCA patients receiving ECPR.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 11, 2017

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

November 17, 2017

Status Verified

October 1, 2017

Enrollment Period

1.7 years

First QC Date

October 30, 2017

Last Update Submit

November 16, 2017

Conditions

Out-Of-Hospital Cardiac Arrest

Keywords

Hypothermia,ECPR

Outcome Measures

Primary Outcomes (1)

  • The feasibility and safety of selective cerebral hypothermia in out-of-hospital cardiac arrest (OHCA) patients receiving ECPR.

    The laboratory tests( CBC, liver function, kidney function, electrolytes,coagulation) . The percentage of subjects who have clinically-significant abnormal findings will be summarized by individual assessments of each category.

    12 hours

Secondary Outcomes (1)

  • The outcome of selective cerebral hypothermia in OHCA patients receiving ECPR.

    6 Month

Study Arms (2)

Selective cerebral hypothermia

EXPERIMENTAL

Selective cerebral hypothermia

Procedure: Selective cerebral hypothermia

Regular hypothermia

ACTIVE COMPARATOR

Regular hypothermia

Procedure: Regular hypothermia

Interventions

Selective cerebral hypothermiaPROCEDURE

Subjects will be transferred to ICU for the 12-hour selective cerebral hypothermia procedure. Cooling will be initiated and targeted to reach ipsilateral nasal temperature of 27±2°C for 12 hours, followed by controlled rewarming.

Selective cerebral hypothermia
Regular hypothermiaPROCEDURE

Subjects will be transferred to ICU for the 12-hour selective cerebral hypothermia procedure. Subjects will receive systemic hypothermia via ECMO at 33.5±0.5°C (33-34°C) for 48 hours at the same time.

Regular hypothermia

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical symptoms and signs compatible with OHCA.
  • Age between 20-65 years.
  • Eligible for initiating ECMO criteria.
  • No flow period less than 10 minutes.
  • CPR for longer than 10 minutes without return of spontaneous circulation (ROSC) under active CPR
  • Unconsciousness. Glasgow Coma Scale (GCS) 7T and M4 with tracheal tube 30 minutes after ECMO setup.
  • The ECMO flow can be maintained stable and return of spontaneous beating after ECMO setup for 2 hours.
  • The blood pressure can be maintained with mean pressure around 55 mmHg for 2 hours.
  • Patient or patient's legal representatives is willing to provide the signed informed consent.
  • Able to provide signed informed consent form (ICF) within 6 hours after the event and proceed to selective cerebral hypothermia within 12 hours after the event.

You may not qualify if:

  • Patients with any of the following characteristics must not be included in the study:
  • ROSC for 20 minutes after resuscitation without repeated collapse
  • Terminal stage malignancy
  • Pre-existing multi-organ dysfunction
  • Ventilator-dependent \> 3 months
  • Bed-ridden \> 3 months, not self-independent before CPR
  • Traumatic origin, uncontrollable bleeding
  • Patients with cerebral aneurysm
  • Patients with sepsis (blood culture positive)
  • Pregnancy
  • CT scan evidence of cerebral hemorrhage or non-ischemic etiology of neurologic symptoms
  • Severe, untreatable aortoiliac disease or small-caliber iliac arteries restricting vascular access with a 14 French sheath
  • Patients with either side common or internal carotid arteries \>50% stenosis and cannot be worked around
  • Patient with "DNR" order

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular Diseases

Study Officials

  • Chen Yih-Sharng

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2017

First Posted

November 17, 2017

Study Start

October 11, 2017

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

November 17, 2017

Record last verified: 2017-10

Locations

TW(1)