Regional Hypothermia in Combination With Endovascular Thrombectomy in Acute Ischemic Stroke (RE-HIBER)

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.

Study Overview

• Status: Unknown
• Conditions: Stroke; Hypothermia; Neuroprotection
• Intervention / Treatment: Other: Regional Hypothermia

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Recruiting
      • Xuanwu Hospital, Capital Medical University
    • Beijing, Beijing, China, 101149
      • Not yet recruiting
      • Lu He hospital, Capital Medical University
      • Contact: Xiaokun Geng, MD; Phone Number: 18311055270; Email: xgeng@ccmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Regional Hypothermia group	Other: Regional Hypothermia; Regional hypothermia was achieved by intraarteral perfusion of cold fluid into the ischemic area of the brain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of any major adverse events	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of intracerebral hemorrhage		24 hours
Rate of symptomatic intracerebral hemorrhage		24 hours
Rate of death		90 days
NIHSS	Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits.	24 hours
Final infarct volume	measured on 5-7 days CT (or MRI if available)	5-7 days
NIHSS	Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits.	7 days or discharge
Modified Rankin scale	The modified Rankin scale is a 7-point scale ranging from 0 (no symptoms) to 6 (death). A score of 2 or less indicates functional independence.	90 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of vessel recanalization after treatment	Assessed by CTA or MRA	24 hours
The temperature change of the tympanic membrane on the ipsilateral side of the vascular occlusion within one hour after endovascular treatment		1 hour
The patient's rectal temperature within one hour after endovascular treatment		1 hour

Collaborators and Investigators

• Sponsor: Capital Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 16, 2020
• Primary Completion (Anticipated): December 16, 2020
• Study Completion (Anticipated): March 16, 2021

Study Registration Dates

• First Submitted: September 13, 2020
• First Submitted That Met QC Criteria: September 13, 2020
• First Posted (Actual): September 18, 2020

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 16, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Body Temperature Changes; Stroke; Ischemic Stroke; Hypothermia
• Other Study ID Numbers: RE-HIBER

Drug and device information, study documents

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