UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014863 |
|---|---|
| Receipt number | R000017277 |
| Scientific Title | HypOthermia for Patients requiring Evacuation of Subdural Hematoma: a Multicenter, Randomized Clinical Trial |
| Date of disclosure of the study information | 2014/08/15 |
| Last modified on | 2016/08/16 07:33:36 |
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Basic information
Public title
HypOthermia for Patients requiring Evacuation of Subdural Hematoma:
a Multicenter, Randomized Clinical Trial
Acronym
HOPES trial
Scientific Title
HypOthermia for Patients requiring Evacuation of Subdural Hematoma:
a Multicenter, Randomized Clinical Trial
Scientific Title:Acronym
HOPES trial
Region
| Japan | North America |
Condition
Condition
Acute Subdural Hematoma
Classification by specialty
| Neurosurgery | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to test whether hypothermia improves outcome following TBI with subdural hema-toma requiring evacuation. The primary objective is to determine if rapid induction of hypothermia prior to emergent craniotomy for traumatic subdural hematoma (SDH) will improve outcome
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparing the ratio of good and poor outcome based on 6-month Glasgow Coma Scale Extended(GOSE)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Preoperatively rapid-induced hypothermia therapy
Interventions/Control_2
Normothermia
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 21 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key 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
Key exclusion criteria
1.Total GCS3 and bilateral fixed and dilated pupils
2.Following commands after an initial period of coma (GCS motor score of 6)
3.Known pre-existing neurological deficit (previous TBI, stroke)
4.Concomitant spinal cord injury
5.Arrival temperature is <35C
6.Hemodynamic instability (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 (heparin induced thrombocytopenia, PE/DVT)
12.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 INR>1.4)
13.Inability to obtain informed consent or utilize exception to informed consent for emer-gency research
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shoji Yokobori |
Organization
Graduated School of Medicine, Nippon Medical School
Division name
Department of Emergency and Critical Care Medicine
Zip code
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
03-3822-2131
shoji@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shoji Yokobori |
Organization
Graduated School of Medicine, Nippon Medical School
Division name
Department of Emergency and Critical Care Medicine
Zip code
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
03-3822-2131
Homepage URL
shoji@nms.ac.jp
Sponsor or person
Institute
Department of Emergency and Critical Care Medicine
Graduated School of Medicine, Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
KAKEN
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
日本医科大学付属病院高度救命救急センターおよびその関連施設,日本医科大学多摩永山病院(東京都)、山口大学附属病院（山口県）、香川大学付属病院（香川県）、大阪府三島救急医療センター（大阪府）、国立病院機構東京災害医療センター（東京都）、長崎大学医学部（長崎県）、久留米大学医学部（福岡県）、済生会福岡総合病院（福岡県）、University of Texas at Houston(TX, USA), University of Miami (FL, USA), University of Pittsburgh (PA, USA)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2015 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 14 | Day |
Last modified on
| 2016 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017277
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
