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Mild Hypothermia After Endovascular Treatment in Acute Ischemic Stroke

NCT02985060 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-12-13

No results posted yet for this study

Summary

To study safety and feasibility of mild therapeutic hypothermia after successful recanalization by mechanical endovascular treatment in patients with acute ischemic stroke and proximal arterial occlusion.

Conditions

Interventions

DEVICE

Arctic Sun

1. Induction phase: At a temperature of 4℃, a saline 500 mL or 1 L is intravenously administered. Arctic sun (surface freezing equipment) Target temperature: 35±0.5℃ Within 12 hours of the onset of symptoms, the therapeutic hypothermia is performed 2. Maintenance phase:The use of bedside shivering assessment scale (BSAS) The use of Columbia anti-shivering protocol,Maintenance period: 48 hours 3. Recovery phase:Rewarming velocity: 0.05\~0.1℃ (within 30 hours)

OTHER

Standard treatment

1. All the patients receive standard treatment modalities for stroke, which are applicable to the international treatment guidelines. 2. In all the patients, neurological assessments and NIHSS scoring are performed on a daily basis for 4 days with the help of board-certified nurses or specialists in stroke. 3. Blood pressure, respiratory rate and heart rate are measured at least once at a 4-hour interval for 4 days. 4. Using an esophageal thermometer, the central temperature is measured at a 2-hour interval for 5 days.

DRUG

Saline

Sponsors & Collaborators

  • Bard Medical Division C.R. Bard Inc

    collaborator UNKNOWN

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • MOON-KU HAN, professor · Seoul National University Bundang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2017-11-30
Completion
2017-11-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

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 NCT02985060 on ClinicalTrials.gov