search
Back to results

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

Primary Purpose

Subdural Hematoma, Traumatic

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Temperature management Zoll Intravascular Temperature Management device
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subdural Hematoma, Traumatic focused on measuring Subdural Hematoma, Traumatic Brain Injury, Hypothermia

Eligibility Criteria

22 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The University off Miami and Ryder Trauma Center, Jackson Memorial Hospital
  • Emory University
  • University of Cincinnati
  • The University of Pittsburgh Medical Center and UPMC Presbyterian
  • The University of Texas at Houston Medical School and Memorial Hermann Hospital
  • Kurume University Hospital
  • Saiseikai Fukuoka General Hospital
  • Kagawa University Hospital
  • Nagasaki University Hospital
  • Osaka Mishima Emergency Critical Care Center
  • National Disaster Medical Center
  • Nippon Medical School Hospital
  • Nippon Medical School Tamanagayama Hospital
  • Yamaguchi University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hypothermia

Normothermia

Arm Description

Hypothermia to 33°C

standard care - normothermia (37°C)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Intensive Care Unit (ICU) Length of Stay
Hospital Length of Stay
Incidence of Cortical Spreading Depolarization

Full Information

First Posted
February 14, 2014
Last Updated
October 14, 2020
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Vivian L. Smith Foundation for Neurologic Research, Zoll Medical Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT02064959
Brief Title
To Study the Effect of Early Cooling in Acute Subdural Hematoma Patients
Acronym
HOPES
Official Title
HypOthermia for Patients Requiring Evacuation of Subdural Hematoma: a Multicenter, Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
interim analysis revealed it was futile, we would not reach an answer at N=60.
Study Start Date
March 22, 2014 (Actual)
Primary Completion Date
February 7, 2019 (Actual)
Study Completion Date
February 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Vivian L. Smith Foundation for Neurologic Research, Zoll Medical Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subdural Hematoma, Traumatic
Keywords
Subdural Hematoma, Traumatic Brain Injury, Hypothermia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hypothermia
Arm Type
Experimental
Arm Description
Hypothermia to 33°C
Arm Title
Normothermia
Arm Type
Active Comparator
Arm Description
standard care - normothermia (37°C)
Intervention Type
Device
Intervention Name(s)
Temperature management Zoll Intravascular Temperature Management device
Primary Outcome Measure Information:
Title
Number of Participants With Favorable Glasgow Outcome Score-Extended (GOS-E) at 6 Months Post Injury
Description
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.
Time Frame
6 months post injury
Secondary Outcome Measure Information:
Title
Safety as Assessed by Number of Adverse Events Reported Per Participant
Description
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.
Time Frame
6 months post injury
Title
Intensive Care Unit (ICU) Length of Stay
Time Frame
from ICU admission to ICU discharge (median of about 11 to 13 days)
Title
Hospital Length of Stay
Time Frame
from hospital admission to hospital discharge (median of about 18 to 21 days)
Title
Incidence of Cortical Spreading Depolarization
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong H. Kim, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Study Chair
Facility Information:
Facility Name
The University off Miami and Ryder Trauma Center, Jackson Memorial Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
The University of Pittsburgh Medical Center and UPMC Presbyterian
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
The University of Texas at Houston Medical School and Memorial Hermann Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Kurume University Hospital
City
Fukuoka
Country
Japan
Facility Name
Saiseikai Fukuoka General Hospital
City
Fukuoka
Country
Japan
Facility Name
Kagawa University Hospital
City
Kagawa
Country
Japan
Facility Name
Nagasaki University Hospital
City
Nagasaki
Country
Japan
Facility Name
Osaka Mishima Emergency Critical Care Center
City
Osaka
Country
Japan
Facility Name
National Disaster Medical Center
City
Tokyo
Country
Japan
Facility Name
Nippon Medical School Hospital
City
Tokyo
Country
Japan
Facility Name
Nippon Medical School Tamanagayama Hospital
City
Tokyo
Country
Japan
Facility Name
Yamaguchi University Hospital
City
Yamaguchi
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data available.
Citations:
PubMed Identifier
34518968
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs