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NOT YET RECRUITING
NCT07896655
NA

Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion

Sponsor: Guangdong Second Provincial General Hospital

View on ClinicalTrials.gov

Summary

This study will examine whether cooling part of the brain through a catheter after endovascular treatment improves recovery in adults with acute basilar artery occlusion, a type of severe stroke. After blood flow has been successfully restored, 818 participants will be randomly assigned to receive either cold saline or room-temperature saline through an artery. The main outcome is the level of disability 90 days later, measured using the modified Rankin Scale. The study will also assess safety, including bleeding in the brain and other complications.

Official title: Selective Intra-Arterial Hypothermia Combined With Endovascular Treatment for Acute Basilar Artery Occlusion (CHILL- BAO): A Multicenter, Prospective, Open-Label, Blinded-Endpoint, Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

818

Start Date

2026-12

Completion Date

2030-03

Last Updated

2026-10-27

Healthy Volunteers

No

Interventions

PROCEDURE

Mechanical thrombectomy

Mechanical thrombectomy

DRUG

Normothermic saline infusion

Participants in the normothermia group will receive a total of 350 mL of room-temperature (22-25°C) normal saline by intra-arterial infusion following endovascular treatment (EVT), at the same fixed rate as the hypothermia group: 30 mL/min.

DRUG

4°C saline infusion

Following successful reperfusion with endovascular treatment (EVT), participants in the hypothermia group will receive a selective intra-arterial infusion of 350 mL of 4°C normal saline at a fixed rate of 30 mL/min. No dose escalation will be performed.

Locations (2)

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, China

Guangdong Second Provincial General Hospital

Guangzhou, Guangdong, China