Selective Cerebral Hypothermia Trial - Under Extracorporeal Cardiopulmonary Resuscitation (SHOT-ECPR)

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

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.

Study Overview

• Status: Unknown
• Conditions: Out-Of-Hospital Cardiac Arrest
• Intervention / Treatment: Procedure: Selective cerebral hypothermia; Procedure: Regular hypothermia

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.

The study intends to enroll 20 subjects and is expected that 10 among the 20 enrolled subjects will receive selective cerebral hypothermia. The data from subjects who do not receive the experimental procedure will be used as the control group when data analyzing for the efficacy and safety of selective cerebral hypothermia.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Main inclusion criteria:

Patients are eligible for inclusion in this study, if they fulfil all of the following criteria:

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

Main exclusion criteria:

Patients with any of the following characteristics must not be included in the study:

1. ROSC for 20 minutes after resuscitation without repeated collapse
2. Terminal stage malignancy
3. Pre-existing multi-organ dysfunction
4. Ventilator-dependent > 3 months
5. Bed-ridden > 3 months, not self-independent before CPR
6. Traumatic origin, uncontrollable bleeding
7. Patients with cerebral aneurysm
8. Patients with sepsis (blood culture positive)
9. Pregnancy
10. CT scan evidence of cerebral hemorrhage or non-ischemic etiology of neurologic symptoms
11. Severe, untreatable aortoiliac disease or small-caliber iliac arteries restricting vascular access with a 14 French sheath
12. Patients with either side common or internal carotid arteries >50% stenosis and cannot be worked around
13. Patient with "DNR" order

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Selective cerebral hypothermia	Procedure: Selective cerebral hypothermia; 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.
Active Comparator: Regular hypothermia	Procedure: Regular hypothermia; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The outcome of selective cerebral hypothermia in 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.	6 Month

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Chen Yih-Sharng, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2017
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): July 1, 2019

Study Registration Dates

• First Submitted: October 30, 2017
• First Submitted That Met QC Criteria: November 16, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): November 17, 2017
• Last Update Submitted That Met QC Criteria: November 16, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Hypothermia,ECPR
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Body Temperature Changes; Heart Arrest; Hypothermia; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: 201603049DIPA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No