Subdural Hematoma, Traumatic Clinical Trial
— HOPESOfficial title:
HypOthermia for Patients Requiring Evacuation of Subdural Hematoma: a Multicenter, Randomized Clinical Trial
| Verified date | September 2020 |
| Source | The University of Texas Health Science Center, Houston |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 32 |
| Est. completion date | February 7, 2019 |
| Est. primary completion date | February 7, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 22 Years to 65 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Kurume University Hospital | Fukuoka | |
| Japan | Saiseikai Fukuoka General Hospital | Fukuoka | |
| Japan | Kagawa University Hospital | Kagawa | |
| Japan | Nagasaki University Hospital | Nagasaki | |
| Japan | Osaka Mishima Emergency Critical Care Center | Osaka | |
| Japan | National Disaster Medical Center | Tokyo | |
| Japan | Nippon Medical School Hospital | Tokyo | |
| Japan | Nippon Medical School Tamanagayama Hospital | Tokyo | |
| Japan | Yamaguchi University Hospital | Yamaguchi | |
| United States | Emory University | Atlanta | Georgia |
| United States | University of Cincinnati | Cincinnati | Ohio |
| United States | The University of Texas at Houston Medical School and Memorial Hermann Hospital | Houston | Texas |
| United States | The University off Miami and Ryder Trauma Center, Jackson Memorial Hospital | Miami | Florida |
| United States | The University of Pittsburgh Medical Center and UPMC Presbyterian | Pittsburgh | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| The University of Texas Health Science Center, Houston | Vivian L. Smith Foundation for Neurologic Research, Zoll Medical Corporation |
United States, Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | Intensive Care Unit (ICU) Length of Stay | from ICU admission to ICU discharge (median of about 11 to 13 days) | ||
| Secondary | Hospital Length of Stay | from hospital admission to hospital discharge (median of about 18 to 21 days) | ||
| Secondary | Incidence of Cortical Spreading Depolarization | 6 months |