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

Primary Purpose

Stroke, Neuroprotection, Hypothermia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Regional Hypothermia
Sponsored by
Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Xuanwu Hospital, Capital Medical UniversityRecruiting
  • Lu He hospital, Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Regional Hypothermia group

Control group

Arm Description

Outcomes

Primary Outcome Measures

Rate of any major adverse events

Secondary Outcome Measures

Rate of intracerebral hemorrhage
Rate of symptomatic intracerebral hemorrhage
Rate of death
NIHSS
Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits.
Final infarct volume
measured on 5-7 days CT (or MRI if available)
NIHSS
Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits.
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.

Full Information

First Posted
September 13, 2020
Last Updated
October 16, 2020
Sponsor
Capital Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04554797
Brief Title
Regional Hypothermia in Combination With Endovascular Thrombectomy in Acute Ischemic Stroke
Acronym
RE-HIBER
Official Title
Regional Hypothermia in Combination With Endovascular Thrombectomy in Acute Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 16, 2020 (Anticipated)
Primary Completion Date
December 16, 2020 (Anticipated)
Study Completion Date
March 16, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Neuroprotection, Hypothermia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Regional Hypothermia group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Regional Hypothermia
Intervention Description
Regional hypothermia was achieved by intraarteral perfusion of cold fluid into the ischemic area of the brain
Primary Outcome Measure Information:
Title
Rate of any major adverse events
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Rate of intracerebral hemorrhage
Time Frame
24 hours
Title
Rate of symptomatic intracerebral hemorrhage
Time Frame
24 hours
Title
Rate of death
Time Frame
90 days
Title
NIHSS
Description
Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits.
Time Frame
24 hours
Title
Final infarct volume
Description
measured on 5-7 days CT (or MRI if available)
Time Frame
5-7 days
Title
NIHSS
Description
Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits.
Time Frame
7 days or discharge
Title
Modified Rankin scale
Description
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.
Time Frame
90 days
Other Pre-specified Outcome Measures:
Title
Rate of vessel recanalization after treatment
Description
Assessed by CTA or MRA
Time Frame
24 hours
Title
The temperature change of the tympanic membrane on the ipsilateral side of the vascular occlusion within one hour after endovascular treatment
Time Frame
1 hour
Title
The patient's rectal temperature within one hour after endovascular treatment
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xunming Ji, MD
Phone
01083199439
Email
jixm@ccmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Chuanjie Wu, MD
Email
wuchuanjie8557@163.com
Facility Information:
Facility Name
Xuanwu Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xunming Ji
First Name & Middle Initial & Last Name & Degree
Xunming Ji
Facility Name
Lu He hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
101149
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaokun Geng, MD
Phone
18311055270
Email
xgeng@ccmu.edu.cn

12. IPD Sharing Statement

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Regional Hypothermia in Combination With Endovascular Thrombectomy in Acute Ischemic Stroke

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