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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

Tracking Information
First Submitted Date  ICMJE February 14, 2014
First Posted Date  ICMJE February 17, 2014
Results First Submitted Date  ICMJE September 21, 2020
Results First Posted Date  ICMJE October 19, 2020
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE March 22, 2014
Actual Primary Completion Date February 7, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 14, 2014)
Extended Outcome Glasgow Scale [ Time Frame: 6 months ]
GOSE at 6 months
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2020)
  • 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.
  • Intensive Care Unit (ICU) Length of Stay [ Time Frame: from ICU admission to ICU discharge (median of about 11 to 13 days) ]
  • Hospital Length of Stay [ Time Frame: from hospital admission to hospital discharge (median of about 18 to 21 days) ]
  • Incidence of Cortical Spreading Depolarization [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Study the Effect of Early Cooling in Acute Subdural Hematoma Patients
Official Title  ICMJE HypOthermia for Patients Requiring Evacuation of Subdural Hematoma: a Multicenter, Randomized Clinical Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Subdural Hematoma, Traumatic
Intervention  ICMJE Device: Temperature management Zoll Intravascular Temperature Management device
Study Arms  ICMJE
  • Experimental: Hypothermia
    Hypothermia to 33°C
    Intervention: Device: Temperature management Zoll Intravascular Temperature Management device
  • Active Comparator: Normothermia
    standard care - normothermia (37°C)
    Intervention: Device: Temperature management Zoll Intravascular Temperature Management device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 5, 2018)
32
Original Estimated Enrollment  ICMJE
 (submitted: February 14, 2014)
350
Actual Study Completion Date  ICMJE February 7, 2019
Actual Primary Completion Date February 7, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02064959
Other Study ID Numbers  ICMJE HSC-MS-12-0762
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data available.
Responsible Party Dong Kim, The University of Texas Health Science Center, Houston
Study Sponsor  ICMJE The University of Texas Health Science Center, Houston
Collaborators  ICMJE
  • Vivian L. Smith Foundation for Neurologic Research
  • Zoll Medical Corporation
Investigators  ICMJE
Study Chair: Dong H. Kim, MD The University of Texas Health Science Center, Houston
PRS Account The University of Texas Health Science Center, Houston
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP