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

• ClinicalTrials.gov Identifier: NCT02064959
• Recruitment Status: Terminated
• First Posted: February 17, 2014
• Results First Posted: October 19, 2020
• Last Update Posted: October 19, 2020
• Sponsor: The University of Texas Health Science Center, Houston
• 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: February 14, 2014
• First Posted Date: February 17, 2014
• Results First Submitted Date: September 21, 2020
• Results First Posted Date: October 19, 2020
• Last Update Posted Date: October 19, 2020
• Actual Study Start Date: March 22, 2014
• Actual Primary Completion Date: February 7, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: February 14, 2014)

Extended Outcome Glasgow Scale [ Time Frame: 6 months ]

GOSE at 6 months

Current Secondary Outcome Measures (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: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: To Study the Effect of Early Cooling in Acute Subdural Hematoma Patients
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Subdural Hematoma, Traumatic
• Intervention: Device: Temperature management Zoll Intravascular Temperature Management device

Study Arms

• 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 *: Hergenroeder GW, Yokobori S, Choi HA, Schmitt K, Detry MA, Schmitt LH, McGlothlin A, Puccio AM, Jagid J, Kuroda Y, Nakamura Y, Suehiro E, Ahmad F, Viele K, Wilde EA, McCauley SR, Kitagawa RS, Temkin NR, Timmons SD, Diringer MN, Dash PK, Bullock R, Okonkwo DO, Berry DA, Kim DH. Hypothermia for Patients Requiring Evacuation of Subdural Hematoma: A Multicenter Randomized Clinical Trial. Neurocrit Care. 2022 Apr;36(2):560-572. doi: 10.1007/s12028-021-01334-w. Epub 2021 Sep 13.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: September 5, 2018): 32
• Original Estimated Enrollment (submitted: February 14, 2014): 350
• Actual Study Completion Date: February 7, 2019
• Actual Primary Completion Date: February 7, 2019 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 22 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan, United States

Administrative Information

• NCT Number: NCT02064959
• Other Study ID Numbers: 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

• Plan to Share IPD: No
• Plan Description: There is no plan to make individual participant data available.

• Current Responsible Party: Dong Kim, The University of Texas Health Science Center, Houston
• Original Responsible Party: Lisa Hollan Schmitt, The University of Texas Health Science Center, Houston, Senior Research Nurse
• Current Study Sponsor: The University of Texas Health Science Center, Houston
• Original Study Sponsor: Same as current

Collaborators

• Vivian L. Smith Foundation for Neurologic Research
• Zoll Medical Corporation

Investigators

• 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