UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037283 |
|---|---|
| Receipt number | R000041737 |
| Scientific Title | An epidemiological study of head trauma patients receiving antithrombotic drugs |
| Date of disclosure of the study information | 2019/10/01 |
| Last modified on | 2023/08/03 22:24:36 |
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Basic information
Public title
An epidemiological study of head trauma patients receiving antithrombotic drugs
Acronym
An epidemiological study of head trauma patients receiving antithrombotic drugs
Scientific Title
An epidemiological study of head trauma patients receiving antithrombotic drugs
Scientific Title:Acronym
An epidemiological study of head trauma patients receiving antithrombotic drugs
Region
| Japan |
Condition
Condition
traumatic brain injury
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This is an epidemiological study involving head trauma patients receiving antithrombotic drugs in Japan. Its purpose is to epidemiologically examine the age, sex, injury mechanism, diagnosis, compliance with antithrombotic drugs, neutralization of these drugs, and outcomes in these patients. The prognosis of elderly patients with head trauma, most of whom currently show unfavorable outcomes, may be improved by clarifying therapeutic effects related to the neutralization of antithrombotic drugs.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
A national survey regarding age/sex/injury mechanism/diagnosis/compliance with antithrombotic drugs/neutralization of these drugs/outcomes involving patients with head trauma will be conducted. Furthermore, whether the contents of treatment influence the outcome will be investigated.In registered patients with head trauma, the status/treatment during the admission period will be examined. Approximately 90 items will be observed.
The outcome will be assessed on discharge and 6 months after injury. The observation period is 6 months after injury at maximum.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The subjects of this study will consist of patients with head trauma, aged over 65 years, requiring admission.
Key exclusion criteria
(1) Chronic subdural hematoma
(2) Patients with cardiopulmonary arrest on arrival
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Eiichi |
| Middle name | |
| Last name | Suehiro |
Organization
Yamaguchi University School of Medicine
Division name
Neurosurgery
Zip code
755-8505
Address
1-1-1 Minamikogushi, Ube, Yamaguchi
TEL
0836-22-2295
suehiro-nsu@umin.ac.jp
Public contact
Name of contact person
| 1st name | Eiichi |
| Middle name | |
| Last name | Suehiro |
Organization
International University of Health and Welfare, School of Medicine
Division name
Neurosurgery
Zip code
286-8520
Address
852 Hatakeda, Narita, Chiba
TEL
0476-35-5600
Homepage URL
suehiro-nsu@umin.ac.jp
Sponsor or person
Institute
The Japan Society of Neurotraumatology
Institute
Department
Personal name
Funding Source
Organization
CSL Behring Co.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Yamaguchi University Hospital
Address
1-1-1 Minamikogushi Ube Yamaguchi
Tel
0836-22-2428
me223@yamaguchi-u.ac.jp
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
山口大学病院（山口県）、日本医科大学病院（東京都）、済生会滋賀県病院（滋賀県）、千葉県救急医療センター（千葉県）、香川大学病院（香川県）、聖マリアンナ医科大学病院（神奈川県）、日本大学病院（東京都）、仙台市立病院（宮城県）、帝京大学病院（東京都）、岩手医科大学病院（岩手県）、熊本赤十字病院（熊本県）、東京医科歯科大学病院（東京都）、加古川医療センター（兵庫県）、土浦協同病院（茨城県）、国立病院機構災害医療センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
1
Publication of results
Partially published
Result
URL related to results and publications
1
Number of participants that the trial has enrolled
721
Results
[Results] In this study, 721 patients were examined. The rates of deterioration during the course were 9.8%, 15.8%, and 31.0% in groups A, B, and C, respectively, showing statistically significant differences. The favorable outcome rates were 57.1%, 52.5%, and 35.8%. The mortality rate was 14.5%, 18.0%. 24.5%. The time from injury to reversal therapy was significantly shorter in the patients without deterioration or in the favorable outcome group (405.9 vs. 880.8 minutes, 261.9 vs 543.4 minutes).
Results date posted
| 2022 | Year | 11 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
721 subjects were registered in this project. The mean age of the subjects (62.6% men) was 79.4 7.8 years. The main mechanisms of injury were tumble in 392 subjects (54.4%) and a traffic accident in 147 subjects (20.4%). The GCS on admission was 11.9 3.9, and the prevalence of pupillary abnormality was 11.0%. In head CT findings, 272 subjects (37.7%) had hematoma with mass effect. Antithrombotic therapy was administered to 253 subjects (35.1%), of which reversal therapy was administered to 53 subjects (20.9%). Acute exacerbation occurred in 84 subjects (11.7%). 143 subjects (19.8%) underwent craniotomy. The rate of favorable outcomes at 6 months after injury was 54.2% and the mortality was 16.2%.
Participant flow
1
Adverse events
nothing
Outcome measures
Although this study could not demonstrate the efficacy of reversal therapy in elderly head injury patients receiving antithrombotic drugs, early administration of reversal drugs improves patient outcomes.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 03 | Month | 09 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 28 | Day |
Date analysis concluded
| 2022 | Year | 09 | Month | 30 | Day |
Other
Other related information
1 age sex
2 mechanisms of injury
3 neurological findings at admission
4 worst neurological findings
5 PT-INR APTT platelet number at admission
6 carbazochrome sodium sulfonate hydrate Tranexamic Acid
7 Former doctor
8 antithrombotic drugs
9 Discontinuation of drug
10 neutralization of drug
11 deterioration
12 CT findings
13 findings of brain herniation
14 operation
15 resume of medicine
16 ischemic complication
17 GOS on admission and at the six months later
Management information
Registered date
| 2019 | Year | 07 | Month | 05 | Day |
Last modified on
| 2023 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041737
