Clinical trial NCT02064959: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Subdural Hematoma, Traumatic
Keywords: Subdural Hematoma
Traumatic Brain Injury
Hypothermia
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: The Vivian L. Smith Center for Neurologic Research
name: Zoll Medical Corporation
First posted: 2014-02-17
Enrollment: 32
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Participants With Favorable Glasgow Outcome Score-Extended (GOS-E) at 6 Months Post Injury
timeFrame: 6 months post injury
Secondary outcomes:
measure: Safety as Assessed by Number of Adverse Events Reported Per Participant
timeFrame: 6 months post injury
measure: Intensive Care Unit (ICU) Length of Stay
timeFrame: from ICU admission to ICU discharge (median of about 11 to 13 days)
measure: Hospital Length of Stay
timeFrame: from hospital admission to hospital discharge (median of about 18 to 21 days)
measure: Incidence of Cortical Spreading Depolarization
timeFrame: 6 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: The University off Miami and Ryder Trauma Center, Jackson Memorial Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Pittsburgh
country: United States
facility: The University of Pittsburgh Medical Center and UPMC Presbyterian
state: Pennsylvania
city: Houston
country: United States
facility: The University of Texas at Houston Medical School and Memorial Hermann Hospital
state: Texas
city: Fukuoka
country: Japan
facility: Kurume University Hospital
city: Fukuoka
country: Japan
facility: Saiseikai Fukuoka General Hospital
city: Kagawa
country: Japan
facility: Kagawa University Hospital
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital
city: Osaka
country: Japan
facility: Osaka Mishima Emergency Critical Care Center
city: Tokyo
country: Japan
facility: National Disaster Medical Center
city: Tokyo
country: Japan
facility: Nippon Medical School Hospital
city: Tokyo
country: Japan
facility: Nippon Medical School Tamanagayama Hospital
city: Yamaguchi
country: Japan
facility: Yamaguchi University Hospital
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Dong H. Kim, MD
role: STUDY_CHAIR
References:
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.