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

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

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.

Study Overview

• Status: Terminated
• Conditions: Subdural Hematoma, Traumatic
• Intervention / Treatment: Device: Temperature management Zoll Intravascular Temperature Management device

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan
    • Kurume University Hospital
  • Fukuoka, Japan
    • Saiseikai Fukuoka General Hospital
  • Kagawa, Japan
    • Kagawa University Hospital
  • Nagasaki, Japan
    • Nagasaki University Hospital
  • Osaka, Japan
    • Osaka Mishima Emergency Critical Care Center
  • Tokyo, Japan
    • Nippon Medical School Hospital
  • Tokyo, Japan
    • National Disaster Medical Center
  • Tokyo, Japan
    • Nippon Medical School Tamanagayama Hospital
  • Yamaguchi, Japan
    • Yamaguchi University Hospital
• United States
  • Florida
    • Miami, Florida, United States, 33136
      • The University off Miami and Ryder Trauma Center, Jackson Memorial Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • The University of Pittsburgh Medical Center and UPMC Presbyterian
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas at Houston Medical School and Memorial Hermann Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Zoll Medical Corporation; Vivian L. Smith Foundation for Neurologic Research
• Investigators: Study Chair: Dong H. Kim, MD, The University of Texas Health Science Center, Houston

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2014
• Primary Completion (Actual): February 7, 2019
• Study Completion (Actual): February 7, 2019

Study Registration Dates

• First Submitted: February 14, 2014
• First Submitted That Met QC Criteria: February 14, 2014
• First Posted (Estimate): February 17, 2014

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 14, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Hypothermia; Traumatic Brain Injury; Subdural Hematoma
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Hematoma; Hematoma, Subdural
• Other Study ID Numbers: HSC-MS-12-0762

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make individual participant data available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes