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

The University of Texas System (UT)

Status: Terminated

Conditions: Subdural Hematoma, Traumatic

Treatments: Device: Temperature management Zoll Intravascular Temperature Management device

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02064959

HSC-MS-12-0762

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 22 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

Hypothermia

Experimental group

Description:

Hypothermia to 33°C

Treatment:

Device: Temperature management Zoll Intravascular Temperature Management device

Normothermia

Active Comparator group

Description:

standard care - normothermia (37°C)

Treatment:

Device: Temperature management Zoll Intravascular Temperature Management device