UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Establishment of prevention method for head injury-related venous thromboembolism using anticoagulant.
Title of the study (Brief title)	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	Tomohito Hirao
Organization	Nagasaki University Hospital
Division name	Emergency Medical Center
Address	1-7-1, Sakamoto, Nagasaki City, Nagasaki
TEL	095-819-7200
Email	thirao56513@gmail.com

Public contact
Name of contact person	Keita Iyama
Organization	Nagasaki University Hospital
Division name	Department of Cardiovascular Medicine
Address	1-7-1, Sakamoto, Nagasaki City, Nagasaki
TEL	095-819-7200
Homepage URL
Email	keita.i0829@gmail.com

Sponsor
Institute	Nagasaki University Hospital Emergency Medical Center
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 03 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036242