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Short-duration Selective Brain Cooling for Patients Undergoing Mechanical Thrombectomy

NCT03163459 · Status: SUSPENDED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2020-08-04

No results posted yet for this study

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

Interventions

DRUG

selective brain cooling by cold saline perfusion

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.

DEVICE

mechanical thrombectomy

conventional mechanical thrombectomy using Solitaire

Sponsors & Collaborators

  • Capital Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-06
Primary Completion
2020-09-30
Completion
2020-12-16

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03163459 on ClinicalTrials.gov