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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.
 
ClinicalTrials.gov Identifier: NCT02064959
Recruitment Status : Terminated (interim analysis revealed it was futile, we would not reach an answer at N=60.)
First Posted : February 17, 2014
Results First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Collaborators:
Vivian L. Smith Foundation for Neurologic Research
Zoll Medical Corporation
Information provided by (Responsible Party):
Dong Kim, The University of Texas Health Science Center, Houston

Study Description
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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 Device: Temperature management Zoll Intravascular Temperature Management device Not Applicable

Study Design
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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
Actual Study Start Date : March 22, 2014
Actual Primary Completion Date : February 7, 2019
Actual Study Completion Date : February 7, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Hypothermia
Hypothermia to 33°C
 Device: Temperature management Zoll Intravascular Temperature Management device
Active Comparator: Normothermia
standard care - normothermia (37°C)
 Device: Temperature management Zoll Intravascular Temperature Management device


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Favorable Glasgow Outcome Score-Extended (GOS-E) at 6 Months Post Injury [ Time Frame: 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.


Secondary Outcome Measures :
  1. Safety as Assessed by Number of Adverse Events Reported Per Participant [ Time Frame: 6 months post injury ]
    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.

  2. Intensive Care Unit (ICU) Length of Stay [ Time Frame: from ICU admission to ICU discharge (median of about 11 to 13 days) ]
  3. Hospital Length of Stay [ Time Frame: from hospital admission to hospital discharge (median of about 18 to 21 days) ]
  4. Incidence of Cortical Spreading Depolarization [ Time Frame: 6 months ]

Eligibility Criteria
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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
Criteria

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.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT02064959


Locations
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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, 30322
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45219
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
Japan
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
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Vivian L. Smith Foundation for Neurologic Research
Zoll Medical Corporation
Investigators
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Study Chair: Dong H. Kim, MD The University of Texas Health Science Center, Houston
  Study Documents (Full-Text)

Documents provided by Dong Kim, The University of Texas Health Science Center, Houston:
Study Protocol and Statistical Analysis Plan  [PDF] March 12, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dong Kim, Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02064959    
Other Study ID Numbers: HSC-MS-12-0762
First Posted: February 17, 2014    Key Record Dates
Results First Posted: October 19, 2020
Last Update Posted: October 19, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Dong Kim, The University of Texas Health Science Center, Houston:
Subdural Hematoma
Traumatic Brain Injury
Hypothermia
Additional relevant MeSH terms:
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Hematoma, Subdural
Hematoma
Hemorrhage
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