To Study the Effect of Early Cooling in Acute Subdural Hematoma Patients

Stopped early · Not applicable

Conditions studied: Subdural Hematoma, Traumatic

In brief

This randomized, prospective trial will study the effect of very early cooling in patients undergoing surgical evacuation of acute subdural hematomas (35°C prior to opening the dura followed by maintenance at 33°C for a minimum of 48h). Intravascular cooling catheters (Thermogard XP Device, Zoll) will be utilized to induce hypothermia or to maintain normothermia. The primary objective is to determine if rapid induction of hypothermia prior to emergent craniotomy for traumatic subdural hematoma (SDH) will improve outcome as measured by Glasgow Outcome Scale-Extended (GOSE) at 6 months.

Key facts

Study ID

NCT02064959

Run by

The University of Texas Health Science Center, Houston

People needed

32

Starts

2014-03-22

Expected to finish

2019-02-07

Last updated by the study team

2020-10-19

Who can join

Age: 22 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Non-penetrating traumatic brain injury
• Glasgow Coma Scale (GCS) motor score ≤5 (not following commands)
• Estimated or known age 22-65 years
• Acute subdural hematoma requiring emergent craniotomy within 6 hours of initial injury
• Estimated time of injury to time to reach temp of 35°C<6 hrs

You may not qualify if…

• Total GCS = 3 and bilateral fixed and dilated pupils
• Following commands after an initial period of coma (GSC motor score of 6)
• Known pre-existing neurological deficit (e.g., previous traumatic brain injury (TBI), stroke)
• Concomitant spinal cord injury
• Arrival temperature is <35°C
• Hemodynamic instability (i.e., mean arterial pressure (MAP)<60 millimetres of mercury (mmHg) for 30 minutes)
• Active cardiac dysrhythmia resulting in hemodynamic instability
• Pregnancy
• Duret hemorrhage
• Prisoner or Ward of the State
• Known history of clotting disorder (e.g., heparin induced thrombocytopenia, pulmonary embolism/deep venous thrombosis)
• 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 international normalized ratio (INR) >1.4)
• Inability to obtain informed consent or utilize exception to informed consent for emergency research.

Where it is running

• The University off Miami and Ryder Trauma Center, Jackson Memorial Hospital — Miami, Florida, United States
• Emory University — Atlanta, Georgia, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• The University of Pittsburgh Medical Center and UPMC Presbyterian — Pittsburgh, Pennsylvania, United States
• The University of Texas at Houston Medical School and Memorial Hermann Hospital — Houston, Texas, United States
• Kurume University Hospital — Fukuoka, Japan
• Saiseikai Fukuoka General Hospital — Fukuoka, Japan
• Kagawa University Hospital — Kagawa, Japan
• Nagasaki University Hospital — Nagasaki, Japan
• Osaka Mishima Emergency Critical Care Center — Osaka, Japan
• National Disaster Medical Center — Tokyo, Japan
• Nippon Medical School Hospital — Tokyo, Japan
• Nippon Medical School Tamanagayama Hospital — Tokyo, Japan
• Yamaguchi University Hospital — Yamaguchi, Japan

Full record on ClinicalTrials.gov

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