UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031763 |
|---|---|
| Receipt number | R000036242 |
| Scientific Title | Establishment of prevention method for head injury-related venous thromboembolism using anticoagulant. |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2018/03/15 11:00:50 |
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Basic information
Public title
Establishment of prevention method for head injury-related venous thromboembolism using anticoagulant.
Acronym
The new protocol of prophylaxis for head injury-related venous thromboembolism by anticoagulation.
Scientific Title
Establishment of prevention method for head injury-related venous thromboembolism using anticoagulant.
Scientific Title:Acronym
The new protocol of prophylaxis for head injury-related venous thromboembolism by anticoagulation.
Region
| Japan |
Condition
Condition
head injury
Classification by specialty
| Cardiology | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Head injury patients who are at high risk of the venous thromboembolism(VTE) undergo prophylactic anticoagulation with unfractionated heparin in addition to intermittent pneumatic compression. We compare incidence of VTE in those patients with historical control of patients treated with only intermittent pneumatic compression.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of venous thromboembolism( VTE) during the hospitalization
Key secondary outcomes
Incidence of hemorrhagic adverse event
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
We perform intravenous administration of unfractionated heparin(10000 unit/day) for 14 days.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Head injury patients with 5 or more points of RAP score.
Key exclusion criteria
The patients that hemostasis is not obtained.
The patients with serious liver dysfunction or renal dysfunction.
The patients with a history of Heparin-induced thrombocytopenia (HIT).
The patients of the drug irritable diathesis such as allergies.
The patients who may be pregnant and breast feeding.
The patients whom a primary investigator judged to be inadequate for the study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomohito Hirao |
Organization
Nagasaki University Hospital
Division name
Emergency Medical Center
Zip code
Address
1-7-1, Sakamoto, Nagasaki City, Nagasaki
TEL
095-819-7200
thirao56513@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keita Iyama |
Organization
Nagasaki University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-7-1, Sakamoto, Nagasaki City, Nagasaki
TEL
095-819-7200
Homepage URL
keita.i0829@gmail.com
Sponsor or person
Institute
Nagasaki University Hospital
Emergency Medical Center
Institute
Department
Personal name
Funding Source
Organization
ZENKYOREN
(National Mutual Insurance Federation of Agricultural Cooperatives)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
長崎大学病院（長崎県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 03 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 16 | Day |
Last modified on
| 2018 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036242
