Regional Hypothermia in Combination With Endovascular Thrombectomy in Acute Ischemic Stroke

Stroke Clinical Trial

— RE-HIBER  

Official title:

Regional Hypothermia in Combination With Endovascular Thrombectomy in Acute Ischemic Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04554797
• Other study ID #: RE-HIBER
• Status: Recruiting
• Phase: N/A
• Start date: October 16, 2020
• Est. completion date: March 16, 2021

Study information

• Verified date: October 2020
• Source: Capital Medical University
• Contact: Xunming Ji, MD
• Phone: 01083199439
• Email: jixm[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 16, 2021
• Est. primary completion date: December 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hypothermia
• Neuroprotection
• Stroke

Intervention

Other:
• Regional Hypothermia
Regional hypothermia was achieved by intraarteral perfusion of cold fluid into the ischemic area of the brain

Locations

Country	Name	City	State
China	Lu He hospital, Capital Medical University	Beijing	Beijing
China	Xuanwu Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of vessel recanalization after treatment	Assessed by CTA or MRA	24 hours
Other	The temperature change of the tympanic membrane on the ipsilateral side of the vascular occlusion within one hour after endovascular treatment		1 hour
Other	The patient's rectal temperature within one hour after endovascular treatment		1 hour
Primary	Rate of any major adverse events		7 days
Secondary	Rate of intracerebral hemorrhage		24 hours
Secondary	Rate of symptomatic intracerebral hemorrhage		24 hours
Secondary	Rate of death		90 days
Secondary	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
Secondary	Final infarct volume	measured on 5-7 days CT (or MRI if available)	5-7 days
Secondary	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
Secondary	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