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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000037283
Receipt No. 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 2021/07/06

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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 Michiyasu
Middle name
Last name Suzuki
Organization Yamaguchi University School of Medicine
Division name Neurosurgery
Zip code 755-8505
Address 1-1-1 Minamikogushi, Ube, Yamaguchi
TEL 0836-22-2295
Email michi@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
Email suehiro-nsu@umin.ac.jp

Sponsor
Institute The Japan Society of Neurotraumatology
Institute
Department

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
Email 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
Publication of results Unpublished

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 No longer recruiting
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 02 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
2021 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041737

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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