Regional Hypothermia in Combination With Endovascular Thrombectomy in Acute Ischemic Stroke

NCT04554797 | Unknown DMC

• 1 other identifier: RE-HIBER
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Rate of any major adverse events

  7 days

Secondary Outcomes (7)

• Rate of intracerebral hemorrhage

  24 hours

• Rate of symptomatic intracerebral hemorrhage

  24 hours

• Rate of death

  90 days

• NIHSS

  24 hours

• Final infarct volume

  5-7 days

Other Outcomes (3)

• Rate of vessel recanalization after treatment

  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

Study Arms (2)

Regional Hypothermia group

EXPERIMENTAL

Other: Regional Hypothermia

Control group

NO INTERVENTION

Interventions

Regional Hypothermia OTHER

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

Regional Hypothermia group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (2)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

Lu He hospital, Capital Medical University

Beijing, Beijing Municipality, 101149, China

NOT YET RECRUITING

MeSH Terms

Conditions

Stroke; Hypothermia

Condition Hierarchy (Ancestors)

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, MD

CONTACT

01083199439; jixm@ccmu.edu.cn

Chuanjie Wu, MD

CONTACT

wuchuanjie8557@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 13, 2020
• First Posted: September 18, 2020
• Study Start: October 16, 2020
• Primary Completion: December 16, 2020
• Study Completion: March 16, 2021
• Last Updated: October 19, 2020

Record last verified: 2020-10

Locations

CN (2)