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interim analysis revealed it was futile, we would not reach an answer at N=60.
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| Name | Class |
|---|---|
| The Vivian L. Smith Center for Neurologic Research | OTHER |
| Zoll Medical Corporation | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypothermia | Experimental | Hypothermia to 33°C |
|
| Normothermia | Active Comparator | standard care - normothermia (37°C) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temperature management Zoll Intravascular Temperature Management device | Device |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dong H. Kim, MD | The University of Texas Health Science Center, Houston | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University off Miami and Ryder Trauma Center, Jackson Memorial Hospital | Miami | Florida | 33136 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34518968 | Derived | 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. |
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There is no plan to make individual participant data available.
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Subjects were randomized and enrolled prior to evacuation of Subdural hematoma
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| ID | Title | Description |
|---|---|---|
| FG000 | Normothermia | Control, temperature maintained at 37°C |
| FG001 | Hypothermia | treatment group, temperature at 35°C at dura opening then 33°C > 48 hours |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 12, 2018 |
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| 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 |
| Emory University |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| University of Cincinnati | Cincinnati | Ohio | 45219 | United States |
| The University of Pittsburgh Medical Center and UPMC Presbyterian | Pittsburgh | Pennsylvania | 15213 | United States |
| The University of Texas at Houston Medical School and Memorial Hermann Hospital | Houston | Texas | 77030 | United States |
| 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 | Japan |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Normothermia | Control, temperature maintained at 37 degrees C |
| BG001 | Hypothermia | treatment group, temperature at 35 degrees C at dura opening then 33 degrees C > 48 hours |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | under 18 years, between 18 and 65 years and greater than 65 years | Mean | Standard Deviation | years |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Two regions enrolled subjects in this study | Number | participants |
| |||||||||||||||||
| Subdural hematoma present | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 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. | Posted | Median | Inter-Quartile Range | number of adverse events per participant | 6 months post injury |
|
| ||||||||||||||||||||||||||||||
| Secondary | Intensive Care Unit (ICU) Length of Stay | Data was not collected for one participant in the normothermia arm. | Posted | Median | Inter-Quartile Range | days | from ICU admission to ICU discharge (median of about 11 to 13 days) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Hospital Length of Stay | Data was not collected for one participant in the normothermia arm. | Posted | Median | Inter-Quartile Range | days | from hospital admission to hospital discharge (median of about 18 to 21 days) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Incidence of Cortical Spreading Depolarization | Data was not collected for this outcome measure. | Posted | 6 months |
|
|
6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Normothermia | Control, temperature maintained at 37°C | 5 | 16 | 10 | 16 | 10 | 16 |
| EG001 | Hypothermia | treatment group, temperature at 35°C at dura opening then 33°C > 48 hours | 3 | 16 | 11 | 16 | 12 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Elevated white blood cell count | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sinus Bradycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tachycardia,agitation | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infection | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mesenteric ischemia with lactic acid disorder (elevated) | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cholecystitis, acute | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Death | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Epidural hematoma | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| hospital readmission,facial droop | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Elevated intracranial pressure | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Intracranial Hemorrhage | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Muscle weakness upper limb | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neurological worsening | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Stroke | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Swelling and Hemorrhage during surgery | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Worsening contusion | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary Tract infection | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Laryngeal edema | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hospital readmission/chest wall hematoma | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sepsis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vascular Access Complication | Surgical and medical procedures | CTCAE (4.0) | Systematic Assessment |
| |
| hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| CPK Increased | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Lymphocyte decreased | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sinus Bradycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Blood Bilirubin increased | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Liver dysfunction | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| lipase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Alkalosis | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Wound Infection | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cranioplasty | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| seizure | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Brain abscess | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Meningitis | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neurological worsening | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Laryngeal edema | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| scalp wound/infection | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Wound drainage | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Replacement of catheter | Surgical and medical procedures | CTCAE (4.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Thrombus(superficial) | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
Early termination leading to small numbers of subjects analyzed.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Georgene W. Hergenroeder, Ph.D., Associate Professor | The University of Texas Health Science Center at Houston | 713-500-6230 | lisa.h.schmitt@uth.tmc.edu |
| Sep 17, 2020 |
| Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D006408 | Hematoma, Subdural |
| D000070642 | Brain Injuries, Traumatic |
| D007035 | Hypothermia |
| ID | Term |
|---|---|
| D020198 | Intracranial Hemorrhage, Traumatic |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006406 | Hematoma |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
| D001930 | Brain Injuries |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
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| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Japan |
|
|
|
|