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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by The University of Texas Health Science Center, Houston
Sponsor:
Collaborators:
Vivian L. Smith Foundation for Neurologic Research
Zoll Medical Corporation
Information provided by (Responsible Party):
Lisa Hollan Schmitt, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT02064959
First received: February 14, 2014
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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 Intervention
Subdural Hematoma, Traumatic
Other: Hypothermia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: HypOthermia for Patients Requiring Evacuation of Subdural Hematoma: a Multicenter, Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Extended Outcome Glasgow Scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    GOSE at 6 months


Estimated Enrollment: 350
Study Start Date: February 2014
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hypothermia
Hypothermia to 33°C
Other: Hypothermia
rapid induction of hypothermia to 35°C followed by maintenance at 33°C
Other Name: Temperature will be managed using the Zoll Intravascular Temperature Management device
No Intervention: Normothermia
standard care - normothermia (37°C)

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Non-penetrating traumatic brain injury
  2. GCS motor score ≤5 (not following commands)
  3. Estimated or known age 21-65 years
  4. Acute subdural hematoma requiring emergent craniotomy within 6 hours of initial injury
  5. Estimated time of injury to time to reach temp of 35°C<6 hrs

Exclusion Criteria:

  1. Total GCS = 3 and bilateral fixed and dilated pupils
  2. Following commands after an initial period of coma (GSC motor score of 6)
  3. Known pre-existing neurological deficit (e.g., previous TBI, stroke)
  4. Concomitant spinal cord injury
  5. Arrival temperature is <35°C
  6. Hemodynamic instability (i.e., MAP<60mmHg for 30 minutes)
  7. Active cardiac dysrhythmia resulting in hemodynamic instability
  8. Pregnancy
  9. Duret hemorrhage
  10. Prisoner or Ward of the State
  11. Known history of clotting disorder (e.g., heparin induced thrombocytopenia, PE/DVT)
  12. Injury to other body organ where hypothermia would be precluded because of bleed-ing risk (e.g., grade 3 liver laceration; bowel laceration; flail lung or INR>1.4)
  13. Inability to obtain informed consent or utilize exception to informed consent for emergency research.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02064959

Contacts
Contact: Lisa H Schmitt, BSN,RN 713-500-6230 Lisa.h.Schmitt@uth.tmc.edu

Locations
United States, Florida
The University off Miami and Ryder Trauma Center, Jackson Memorial Hospital Not yet recruiting
Miami, Florida, United States, 33136
Sub-Investigator: Ross Bullock, MD,PhD         
Principal Investigator: Jonathan Jagid, MD         
United States, Pennsylvania
The University of Pittsburgh Medical Center and UPMC Presbyterian Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Principal Investigator: David O Okonkwo, MD,PhD         
United States, Texas
The University of Texas at Houston Medical School and Memorial Hermann Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Lisa H Schmitt, BSN, RN    713-500-6230    Lisa.h.Schmitt@uth.tmc.edu   
Principal Investigator: Dong H. Kim, MD         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
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
  More Information

No publications provided

Responsible Party: Lisa Hollan Schmitt, Senior Research Nurse, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02064959     History of Changes
Other Study ID Numbers: HSC-MS-12-0762
Study First Received: February 14, 2014
Last Updated: March 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by The University of Texas Health Science Center, Houston:
Subdural Hematoma
Traumatic Brain Injury
Hypothermia

Additional relevant MeSH terms:
Hematoma
Hematoma, Subdural
Hematoma, Subdural, Acute
Hypothermia
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
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014