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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02064959
Recruitment Status : Active, not recruiting
First Posted : February 17, 2014
Last Update Posted : January 17, 2019
Vivian L. Smith Foundation for Neurologic Research
Zoll Medical Corporation
Information provided by (Responsible Party):
Lisa Hollan Schmitt, The University of Texas Health Science Center, Houston

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Subdural Hematoma, Traumatic Other: Hypothermia Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: HypOthermia for Patients Requiring Evacuation of Subdural Hematoma: a Multicenter, Randomized Clinical Trial
Study Start Date : February 2014
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

Arm Intervention/treatment
Experimental: Hypothermia
Hypothermia to 33°C
Other: Hypothermia
rapid induction of hypothermia to 35°C followed by maintenance at 33°C
Other Name: Temperature will be managed using the Zoll Intravascular Temperature Management device

No Intervention: Normothermia
standard care - normothermia (37°C)

Primary Outcome Measures :
  1. Extended Outcome Glasgow Scale [ Time Frame: 6 months ]
    GOSE at 6 months

Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  1. Total GCS = 3 and bilateral fixed and dilated pupils
  2. Following commands after an initial period of coma (GSC motor score of 6)
  3. Known pre-existing neurological deficit (e.g., previous TBI, stroke)
  4. Concomitant spinal cord injury
  5. Arrival temperature is <35°C
  6. Hemodynamic instability (i.e., 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 (e.g., heparin induced thrombocytopenia, PE/DVT)
  12. Injury to other body organ where hypothermia would be precluded because of bleed-ing 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 emergency research.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02064959

United States, Florida
The University off Miami and Ryder Trauma Center, Jackson Memorial Hospital
Miami, Florida, United States, 33136
United States, Georgia
Emory University
Atlanta, Georgia, United States
United States, Pennsylvania
The University of Pittsburgh Medical Center and UPMC Presbyterian
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
The University of Texas at Houston Medical School and Memorial Hermann Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Vivian L. Smith Foundation for Neurologic Research
Zoll Medical Corporation
Study Chair: Dong H. Kim, MD The University of Texas Health Science Center, Houston

Responsible Party: Lisa Hollan Schmitt, Senior Research Nurse, The University of Texas Health Science Center, Houston Identifier: NCT02064959     History of Changes
Other Study ID Numbers: HSC-MS-12-0762
First Posted: February 17, 2014    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data available.

Keywords provided by Lisa Hollan Schmitt, The University of Texas Health Science Center, Houston:
Subdural Hematoma
Traumatic Brain Injury

Additional relevant MeSH terms:
Hematoma, Subdural
Pathologic Processes
Intracranial Hemorrhage, Traumatic
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Vascular Diseases
Cardiovascular Diseases
Wounds and Injuries