Regional Hypothermia in Combination With Endovascular Thrombectomy in Acute Ischemic Stroke

NCT ID: NCT04554797

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-16
• Study Completion Date: 2021-03-16

Brief Summary

The investigators have previous shown that regional hypothermia by the intra-arterial infusion of cold saline combined with mechanical thrombectomy in acute ischemic stroke is feasible and safe. The safety of selective brain cooling in patients undergoing mechanical thrombectomy, however, is not established in a randomized trial. The investigators therefore conducted this RCT study to further explore the safety of regional hypothermia in patients with acute ischemic stroke who underwent mechanical thrombectomy.

Conditions

Stroke; Neuroprotection; Hypothermia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Regional Hypothermia group

Group Type: EXPERIMENTAL

Regional Hypothermia

Intervention Type: OTHER

Regional hypothermia was achieved by intraarteral perfusion of cold fluid into the ischemic area of the brain

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Regional Hypothermia

Regional hypothermia was achieved by intraarteral perfusion of cold fluid into the ischemic area of the brain

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age ≥18 and ≤80
• Clinical signs consistent with the diagnosis of an acute ischemic stroke
• Baseline NIHSS score obtained prior to randomization ≥8
• Intracranial arterial occlusion of the distal intracranial carotid artery or
• Middle (M1/M2), demonstrated with CTA, MRA, DSA
• The possibility to start treatment (artery puncture) within 6 hours from onset
• Regional hypothermia is expected to start within 15 minutes after recanalization
• Informed consent given

Exclusion Criteria

• mTICI<2b after endovascular treatment
• No significant pre-stroke disability (mRS ≤1)
• Previous NYHA grade > 1
• Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 3.0
• Baseline platelet count < 50000/µL
• Baseline blood glucose of < 50mg/dL or >400mg/dl
• Severe, sustained hypertension (SBP > 220 mm Hg or DBP > 110 mm Hg). NOTE: If the blood pressure can be successfully reduced and maintained at the acceptable level using local treatment guidelines recommended medication (including iv antihypertensive drips), the patient can be enrolled.
• Seizures at stroke onset which would preclude obtaining a baseline NIHSS
• Subjects who have received iv t-PA treatment beyond 4,5 hours from the beginning of the symptoms
• Renal insufficiency with creatinine ≥ 3 mg/dl
• Woman of childbearing potential who is known to be pregnant or lactating
• Subject participating in a study involving an investigational drug or device that would impact this study
• Cerebral vasculitis
• Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations
• Unlikely to be available for 3 months follow-up (e.g. no fixed home address, visitor from overseas).
• CT or MR evidence of hemorrhage (the presence of microbleeds on MRI is allowed)
• ASPECT<6
• Subjects with occlusions in multiple vascular territories (anterior circulation and posterior circulation)
• Evidence of intracranial tumor (except small meningioma)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 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

Locations

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Lu He hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status: NOT_YET_RECRUITING

Countries

China

Central Contacts

Xunming Ji, MD

Role: CONTACT

jixm@ccmu.edu.cn

01083199439

Chuanjie Wu, MD

Role: CONTACT

wuchuanjie8557@163.com

Facility Contacts

Xunming Ji

Role: primary

Xiaokun Geng, MD

Role: primary

xgeng@ccmu.edu.cn

18311055270

Other Identifiers

RE-HIBER

Identifier Type: -

Identifier Source: org_study_id