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Clinical Trials/NCT03345706
NCT03345706UnknownNot Applicable

To Evaluate the Feasibility and Safety of Selective Cerebral Hypothermia in Out-of-hospital Cardiac Arrest (OHCA) Patients Receiving ECPR.

National Taiwan University Hospital2 sites in 1 country20 target enrollmentStarted: October 11, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
20
Locations
2
Primary Endpoint
The feasibility and safety of selective cerebral hypothermia in out-of-hospital cardiac arrest (OHCA) patients receiving ECPR.

Study Overview

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.

Detailed Description

Patients with OHCA and meeting the criteria for initiating extracorporeal membrane oxygenation (ECMO) criteria will be checked for eligibility for the study during CPR by the emergency physicians or staff at the scene. Informed consent will be asked as well. The standard V-A circuit for ECMO will be applied to the patients as soon as they arriving ER following the standard operation procedure of the hospital. The necessary testing and procedures will be applied to check the eligibility of the patients. Eligible subjects and/or their legal representatives will be further confirmed for the consent of experimental selective cerebral hypothermia. Systemic hypothermia at 33.5+/-0.5°C (33-34°C) for 48 hours will be performed to all eligible subjects.

For subjects who consent to receive selective cerebral hypothermia, they will be transferred to the catheterization lab for the blood flow controlling and cooling system settlement. Subjects then 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. Both ipsilateral and contralateral nasal temperature will be monitored throughout. Activated clotting time (ACT) monitoring should be performed every 2 hours till stable and then every 12 hours during the whole cooling procedure. Also, subjects will receive systemic hypothermia via ECMO at 33.5+/-0.5°C (33-34°C) for 48 hours at the same time.

Subjects will stay and be observed in ICU until subject's condition is stable and can be transferred to general ward by investigator's judgment. The weaning of ECMO will be judged by investigator based on the subject's condition.

For subjects who do not agree to receive selective cerebral hypothermia, only the systemic hypothermia via ECMO will be applied. Subjects will receive systemic hypothermia at 33.5+/-0.5°C (33-34°C) for 48 hours via ECMO following the standard operative procedure.

Subject weaned from ECMO will be transferred to ward and will be followed until 6 months after the event. Outcome improvement and safety will be evaluated following scheduled timeline.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
20 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Selective cerebral hypothermia

Experimental

Selective cerebral hypothermia

Intervention: Selective cerebral hypothermia (Procedure)

Regular hypothermia

Active Comparator

Regular hypothermia

Intervention: Regular hypothermia (Procedure)

Outcomes

Primary Outcomes

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

Time Frame: 12 hours

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.

Secondary Outcomes

  • The outcome of selective cerebral hypothermia in OHCA patients receiving ECPR.(6 Month)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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