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Beneficial Effect of Hypothermia Plus Hemicraniectomy Compared With Hemicraniectomy

Hypothermia Clinical Trial

Official title:
Beneficial Effect of Therapeutic Hypothermia Plus Hemicraniectomy Compared With Hemicraniectomy Alone in Patients With Malignant Cerebral Infarction (BETHLeHAM Study) - Prospective, Open, Single-arm, Multicenter Phase II Study

Clinical Trial Summary

To study safety and feasibility of mild therapeutic hypothermia after decompressive hemicraniectomy compared with hemicraniectomy alone in patients with malignant cerebral infarction

Clinical Trial Description

The current clinical trial is an investigator-initiated one, and it is conducted under the multi-center, single arm, open-label, prospective design. The subject meeting inclusion/exclusion criteria will be assigned to treatment group. The subjects of treatment group should be initiated hypothermia therapy as soon as possible after surgery (less than 6 hours). It can be duration at least 72 hours according to subject status. Also process of recovery temperature period will be allowed within 20-40 hours. After 6 month, 12 month of the onset of symptom, mRS score are measured. This is followed by closure of clinical trial. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04825418
Study type Interventional
Source Seoul National University Hospital
Contact Moon-ku Han
Phone 82-31-787-7464
Email mkhan@snu.ac.kr
Status Not yet recruiting
Phase N/A
Start date May 2021
Completion date December 2025
View Details
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