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

Study Overview
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Brief Summary
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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.

Official Title
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HypOthermia for Patients Requiring Evacuation of Subdural Hematoma: a Multicenter, Randomized Clinical Trial

Conditions
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Subdural Hematoma, Traumatic

Intervention / Treatment
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* Device: Temperature management Zoll Intravascular Temperature Management device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypothermia<br>Hypothermia to 33°C | Device: Temperature management Zoll Intravascular Temperature Management device<br> <br> |
| Active Comparator: Normothermia<br>standard care - normothermia (37°C) | Device: Temperature management Zoll Intravascular Temperature Management device<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Favorable Glasgow Outcome Score-Extended (GOS-E) at 6 Months Post Injury | Participants were monitored for 6 months after injury, and GOS-E was scored as favorable (moderate disability to good recovery) or unfavorable (severe disability, vegetative state, or death) at 6 months post-injury. | 6 months post injury | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as Assessed by Number of Adverse Events Reported Per Participant | Adverse events were graded according to the USDHHS Common Terminology Criteria for Adverse Events V4.0. Serious adverse events and pre-defined adverse events of interest that historically were known to be of concern with hypothermia treatment were selected to be monitored and reported regardless of grade. These included cardiac arrhythmias, thromboembolic events, pneumonia, bleeding or hemorrhage, intraoperative hemorrhage, infection (culture positive, e.g., blood stream infection, urinary tract infection, ventriculitis), device-related infection, and death. The number of adverse events per participant were compared between groups. | 6 months post injury | 
| Intensive Care Unit (ICU) Length of Stay |  | from ICU admission to ICU discharge (median of about 11 to 13 days) | 
| Hospital Length of Stay |  | from hospital admission to hospital discharge (median of about 18 to 21 days) | 
| Incidence of Cortical Spreading Depolarization |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Subdural Hematoma, Traumatic Brain Injury, Hypothermia