Hypothermia With Intrajugular Cooling in Acute Ischemic Stroke Thrombectomy

NCT05488392 | Unknown DMC

• 1 other identifier: PICNIC
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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

Keywords

acute ischemic stroke; hypothermia; thrombectomy; intrajugular cooling

Outcome Measures

Primary Outcomes (1)

• Number of participants with major response

  Major response is any of the following: 1. Cerebral venous system damage; 2. Cerebral venous thrombosis; 3. Huge hematoma at the puncture site requiring surgical intervention; 4. Malignant arrhythmia within 24 hours; 5. Cardiac arrest within 24 hours; 6. Myocardial infarction within 24 hours; 7. Congestive heart failure within 24 hours. In the 3 + 3 design, 3 subjects are recruited for a given intrajugular cooling dose level. The trial is stopped if ≥ 2 of 3 subjects at a given dose level show major response. If only 1 of 3 subjects shows major response, 3 more subjects are recruited at a given dose level and a major response in any of them will stop the trial. Otherwise, same procedure is followed for the next dose level. Maximum tolerable dose will be the dose at the level before stopping of the trial. The schedule of advancing duration is 10 min, 15 min, 20 min, 25 min, and 30 min.

  Within 24 hours after hypothermia with intrajugular cooling

Study Arms (1)

Intrajugular cooling group

EXPERIMENTAL

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

Procedure: Hypothermia with intrajugular cooling

Interventions

Hypothermia with intrajugular cooling 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.

Intrajugular cooling group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years;
• Acute ischemic stroke caused by unilateral internal carotid artery terminal segment/middle cerebral artery M1 segment occlusion;
• In line with the indications for mechanical thrombectomy without contraindications;
• Successful recanalization (mTICI 2b/3) after mechanical thrombectomy that confirmed by digital subtraction angiography;
• Written informed consent provided by the patients or their legal relatives.

You may not qualify if:

• Suffering from cerebral venous system diseases such as cerebral venous thrombosis/stenosis/dysplasia;
• Suffering from heart diseases such as ventricular arrhythmia/myocardial infarction/congestive heart failure;
• Imaging examination after mechanical thrombectomy shows intracranial hemorrhage/contrast extravasation;
• Difficulty in reaching the designated position of the device used for intrajugular cooling;

Sponsors & Collaborators

• Capital Medical University: lead

MeSH Terms

Conditions

Ischemic Stroke; Hypothermia

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xunming Ji, M.D.

CONTACT

010-83198952; jixm@ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: August 4, 2022
• Study Start: November 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: February 1, 2024
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share