HypOthermia for Patients requiring Evacuation of Subdural Hematoma: a Multicenter, Randomized Clinical Trial

Not Applicable

• Conditions: Acute Subdural Hematoma

• Registration Number: JPRN-UMIN000014863
• Lead Sponsor: Department of Emergency and Critical Care Medicine Graduated School of Medicine, Nippon Medical School

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-08-15
• Study Completion: 2018-09-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

1.Total GCS3 and bilateral fixed and dilated pupils 2.Following commands after an initial period of coma (GCS motor score of 6) 3.Known pre-existing neurological deficit (previous TBI, stroke) 4.Concomitant spinal cord injury 5.Arrival temperature is <35C 6.Hemodynamic instability (MAP<60mmHg for 30 minutes) 7.Active cardiac dysrhythmia resulting in hemodynamic instability 8.Pregnancy 9.Duret hemorrhage 10.Prisoner or Ward of the State 11.Known history of clotting disorder (heparin induced thrombocytopenia, PE/DVT) 12.Injury to other body organ where hypothermia would be precluded because of bleeding risk (e.g., grade 3 liver laceration; bowel laceration; flail lung or INR>1.4) 13.Inability to obtain informed consent or utilize exception to informed consent for emer-gency research

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparing the ratio of good and poor outcome based on 6-month Glasgow Coma Scale Extended(GOSE)