Subdural Hematoma, TraumaticHOPESNCT02064959
To Study the Effect of Early Cooling in Acute Subdural Hematoma Patients
A study testing Temperature management Zoll Intravascular Temperature Management device in people with Subdural Hematoma, Traumatic, run by The University of Texas Health Science Center, Houston at 14 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Subdural Hematoma, Traumatic
- What is being tested?
- Temperature management Zoll Intravascular Temperature Management device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 22 Mar 2014to 7 Feb 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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.
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
Japan9 sites
Kurume University Hospital
Fukuoka
Saiseikai Fukuoka General Hospital
Fukuoka
Kagawa University Hospital
Kagawa
Nagasaki University Hospital
Nagasaki
Osaka Mishima Emergency Critical Care Center
Osaka
National Disaster Medical Center
Tokyo
Nippon Medical School Hospital
Tokyo
Nippon Medical School Tamanagayama Hospital
Tokyo
Yamaguchi University Hospital
Yamaguchi
United States5 sites
Emory University
Atlanta, Georgia, 30322
University of Cincinnati
Cincinnati, Ohio, 45219
The University of Texas at Houston Medical School and Memorial Hermann Hospital
Houston, Texas, 77030
The University off Miami and Ryder Trauma Center, Jackson Memorial Hospital
Miami, Florida, 33136
The University of Pittsburgh Medical Center and UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213
About this study
Official title: HypOthermia for Patients Requiring Evacuation of Subdural Hematoma: a Multicenter, Randomized Clinical Trial
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.
- Conditions
- Subdural Hematoma, Traumatic
- Being tested
- Temperature management Zoll Intravascular Temperature Management device
- Keywords
- Subdural Hematoma, Traumatic Brain Injury, Hypothermia
- Medical subject headings
- Hematoma, Subdural, Brain Injuries, Traumatic, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temperature management Zoll Intravascular Temperature Management deviceDevice
| Study group | Role | What they receive |
|---|---|---|
| Hypothermia | Experimental | Hypothermia to 33°C Receives: Device: Temperature management Zoll Intravascular Temperature Management device |
| Normothermia | Active comparator | standard care - normothermia (37°C) Receives: Device: Temperature management Zoll Intravascular Temperature Management device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months post injury
Secondary outcomes (4)
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.
Measured: 6 months post injury
Intensive Care Unit (ICU) Length of Stay
Measured: from ICU admission to ICU discharge (median of about 11 to 13 days)
Hospital Length of Stay
Measured: from hospital admission to hospital discharge (median of about 18 to 21 days)
Incidence of Cortical Spreading Depolarization
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study start22 Mar 2014
- Primary completion7 Feb 2019
- Study completion7 Feb 2019
Why it stopped: interim analysis revealed it was futile, we would not reach an answer at N=60.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subdural Hematoma, TraumaticStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Vivian L. Smith Center for Neurologic Research, Zoll Medical Corporation
- Responsible party
- Principal investigator, Dong Kim, The University of Texas Health Science Center, Houston
- Investigators
- Dong H. Kim, MD, Study chair, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02064959
- Sponsor's protocol ID
- HSC-MS-12-0762
- Acronym
- HOPES
- Status last verified
- Sep 2020
- First submitted
- 14 Feb 2014
- Last updated
- 19 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to make individual participant data available.
Publications
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.
PubMed 34518968
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HypOthermia for Patients Requiring Evacuation of Subdural Hematoma: a Multicenter, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02064959
- Acronym / sponsor ID
- HOPES / HSC-MS-12-0762
- Conditions
- Subdural Hematoma, Traumatic
- Keywords
- Subdural Hematoma, Traumatic Brain Injury, Hypothermia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: interim analysis revealed it was futile, we would not reach an answer at N=60.
- Enrolment
- 32 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- The Vivian L. Smith Center for Neurologic Research, Zoll Medical Corporation
- Study start
- 22 Mar 2014 (actual)
- Primary completion
- 7 Feb 2019 (actual)
- Study completion
- 7 Feb 2019 (actual)
- First posted
- 17 Feb 2014 (estimated)
- Results
- Posted 19 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypothermia | Experimental | Device: Temperature management Zoll Intravascular Temperature Management deviceHypothermia to 33°C |
| Normothermia | Active comparator | Device: Temperature management Zoll Intravascular Temperature Management devicestandard care - normothermia (37°C) |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temperature management Zoll Intravascular Temperature Management device | Device | Hypothermia, Normothermia |
Primary outcome
Number of Participants With Favorable Glasgow Outcome Score-Extended (GOS-E) at 6 Months Post Injury
Time frame: 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.
4 secondary outcomes
Safety as Assessed by Number of Adverse Events Reported Per Participant
Time frame: 6 months post injury
Intensive Care Unit (ICU) Length of Stay
Time frame: from ICU admission to ICU discharge (median of about 11 to 13 days)
Hospital Length of Stay
Time frame: from hospital admission to hospital discharge (median of about 18 to 21 days)
Incidence of Cortical Spreading Depolarization
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34518968Hergenroeder 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.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dong H. Kim, MD study chair
The University of Texas Health Science Center, Houston
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temperature management Zoll Intravascular Temperature Management device in people with Subdural Hematoma, Traumatic, run by The University of Texas Health Science Center, Houston at 14 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Japan, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Favorable Glasgow Outcome Score-Extended (GOS-E) at 6 Months Post Injury (time frame: 6 months post injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02064959, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.