Hypothermia With Intrajugular Cooling in Acute Ischemic Stroke Thrombectomy

NCT ID: NCT05488392

Last Updated: 2022-08-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2024-02-01

Brief Summary

Hypothermia with intrajugular cooling is a neuroprotective strategy that has been proven to minimize brain damage and maximize functional preservation in animal models of stroke. The purpose of this proof-of-concept study is to determine the safety and tolerability of intrajugular cooling in patients with acute ischemic stroke who are treated with mechanical thrombectomy.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intrajugular cooling group

The safety and tolerability of hypothermia with intrajugular cooling will be investigated using 3+3 dose-escalation trial design.

Group Type: EXPERIMENTAL

Hypothermia with intrajugular cooling

Intervention Type: PROCEDURE

Hypothermia with intrajugular cooling will be applied after successful recanalization of the culprit internal carotid artery/middle cerebral artery. The perfusion rate will be set at 30 ml/min. Low temperature saline will be infused into the internal jugular vein for 10 min, 15 min, 20 min, 25 min, and 30 min successively.

Interventions

Hypothermia with intrajugular cooling

Hypothermia with intrajugular cooling will be applied after successful recanalization of the culprit internal carotid artery/middle cerebral artery. The perfusion rate will be set at 30 ml/min. Low temperature saline will be infused into the internal jugular vein for 10 min, 15 min, 20 min, 25 min, and 30 min successively.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age 18-80 years;

2. Acute ischemic stroke caused by unilateral internal carotid artery terminal segment/middle cerebral artery M1 segment occlusion;

3. In line with the indications for mechanical thrombectomy without contraindications;

4. Successful recanalization (mTICI 2b/3) after mechanical thrombectomy that confirmed by digital subtraction angiography;

5. Written informed consent provided by the patients or their legal relatives.

Exclusion Criteria

1. Suffering from cerebral venous system diseases such as cerebral venous thrombosis/stenosis/dysplasia;

2. Suffering from heart diseases such as ventricular arrhythmia/myocardial infarction/congestive heart failure;

3. Imaging examination after mechanical thrombectomy shows intracranial hemorrhage/contrast extravasation;

4. Difficulty in reaching the designated position of the device used for intrajugular cooling;

5. Difficulty in complying with intrajugular cooling or other conditions that the investigator considered inappropriate for inclusion.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ji Xunming,MD,PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Xunming Ji, M.D.

Role: CONTACT

jixm@ccmu.edu.cn

010-83198952

Other Identifiers

PICNIC

Identifier Type: -

Identifier Source: org_study_id