Short-duration Selective Brain Cooling for Patients Undergoing Mechanical Thrombectomy

NCT03163459 | Suspended Phase 2 DMC

• 1 other identifier: ET-EH
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the efficacy and safety of short-duration intra-artery selective brain cooling in addition to mechanical thrombectomy in patients with acute ischemic stroke.

Conditions

Hypothermia; Stroke, Acute

Keywords

mechanical thrombectomy; selective brain cooling

Outcome Measures

Primary Outcomes (1)

• Proportion of patients achieving favorable outcomes defined as mRS 0-2 at 90 days as evaluated by independent central assessors who are blinded to treatment

  mRS 0-2

  90 days

Secondary Outcomes (8)

• Dramatic early favorable response

  24 hours

• Final infarct volume evaluated on CT/MR at 24 hours (-2/+12 hours)

  24 hours

• The change of infarct volume compared with baseline.

  24 hours

• Vessel recanalization

  24 hours

• Barthel Index at 90 days

  90 days

Other Outcomes (7)

• Mortality at 90 days

  90 days

• Clinically significant ICH rates at 24 (-2/+12) hours.

  24 hours

• Procedural related complications

  From the operation to 24 hours after the operation

Study Arms (2)

mechanical thrombectomy group

ACTIVE COMPARATOR

Conventional mechanical thrombectomy

Device: mechanical thrombectomy

mechanical thrombectomy plus selective brain cooling group

EXPERIMENTAL

A microcatheter which was used to deploy the stent retriever was threaded into the femoral artery in the groin through a guiding catheter and up through the neck, until it reached beyond the clot causing the stroke under the assistance of micro-guide wire, 50 mL cold 0.9% saline (4°C) was infused into the ischemic territory at 10 mL/min through the microcatheter, thus allowing the cold solution to infuse into the ischemic territory prior to reperfusion. After that, mechanical thrombectomy with a stent retriever was performed to recanalize the occluded vessel as soon as possible. After the recanalization, cold 0.9% saline (4°C) was infused into the ischemic brain tissue through the guide catheter at 30 mL/min for 10 minutes.

Drug: selective brain cooling by cold saline perfusion; Device: mechanical thrombectomy

Interventions

selective brain cooling by cold saline perfusion DRUG

During the procedure, a microcatheter which was used to deploy the stent retriever was threaded into the femoral artery in the groin through a guiding catheter and up through the neck, until it reached beyond the clot causing the stroke under the assistance of micro-guide wire, 50 mL cold 0.9% saline (4°C) was infused into the ischemic territory at 10 mL/min through the microcatheter, thus allowing the cold solution to infuse into the ischemic territory prior to reperfusion. After that, mechanical thrombectomy with a stent retriever was performed to recanalize the occluded vessel as soon as possible. After the recanalization, cold 0.9% saline (4°C) was infused into the ischemic brain tissue through the guide catheter at 30 mL/min for 10 minutes.

mechanical thrombectomy plus selective brain cooling group

mechanical thrombectomy DEVICE

conventional mechanical thrombectomy using Solitaire

mechanical thrombectomy group; mechanical thrombectomy plus selective brain cooling group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute ischemic stroke within 6 hours from symptom onset/last seen well.
• Occlusion (TIMI 0-1) of the basilar artery or distal intracranial carotid artery or middle (M1/M2) or anterior (A1/A2) cerebral artery as evidenced by CTA/MRA/DSA.
• Age ≥18 and ≤80
• No significant pre-stroke functional disability (mRS ≤ 1)
• The possibility to start treatment within 6 hours from onset.
• Informed consent given

You may not qualify if:

• Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR \> 3.0
• Baseline platelet count \< 50.000/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 below these levels using commonly used medications in China for these purposes (including iv antihypertensive drips), the patient can be enrolled.
• Serious, advanced, or terminal illness with anticipated life expectancy of less than one year.
• History of life threatening allergy (more than rash) to contrast medium
• Subjects who has received iv t-PA treatment beyond 4.5 hours from the beginning of the symptoms.
• Patients with acute stroke within the first 48 hours after percutaneous cardiac, cerebrovascular interventions and major surgery
• Renal insufficiency with creatinine ≥ 3 mg/dl
• Woman of childbearing potential who is known to be pregnant or lactating or who has a positive pregnancy test on admission.
• 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, mRS score at baseline must be ≤ 1, which includes patients who are severely demented, require constant assistance in a nursing home type setting or who live at home but are not fully independent in activities of daily living (toileting, dressing, eating, cooking and preparing meals, etc.)
• Unlikely to be available for 90 days 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).

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Xuan Wu Hospital，Capital Medical University

Beijing, Beijing Municipality, 100069, China

Location

Related Publications (1)

• Chen J, Liu L, Zhang H, Geng X, Jiao L, Li G, Coutinho JM, Ding Y, Liebeskind DS, Ji X. Endovascular Hypothermia in Acute Ischemic Stroke: Pilot Study of Selective Intra-Arterial Cold Saline Infusion. Stroke. 2016 Jul;47(7):1933-5. doi: 10.1161/STROKEAHA.116.012727. Epub 2016 May 19.

  PMID: 27197848 BACKGROUND

MeSH Terms

Conditions

Hypothermia; Stroke

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President

Study Record Dates

• First Submitted: May 6, 2017
• First Posted: May 23, 2017
• Study Start: February 6, 2018
• Primary Completion: September 30, 2020
• Study Completion: December 16, 2020
• Last Updated: August 4, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)