UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter prospective intervention study to evaluate the efficacy of prophylaxis for venous thromboembolism with antithrombotic drugs in Japanese inflammatory bowel disease inpatients.
Title of the study (Brief title)	Efficacy of prophylaxis for venous thromboembolism with antithrombotic drugs in Japanese IBD inpatients.
Region	Japan

Condition
Condition	Inflammatory bowel disease
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To reveal the efficacy of prophylaxis for venous thromboembolism(VTE) with antithrombotic drugs in Japanese inpatients with inflammatory bowel disease(IBD).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The incidence of VTE at 2 weeks after starting administration of unfractionated heparin(UFH) for prophylaxis to inpatients with IBD.
Key secondary outcomes	1, The incidence of VTE on admission. (within 48 hours after admission) 2, The incidence of VTE at 2 to 6 months after admission. 3, The duration of administration of UFH for prophylaxis (days). 4, The incidence of hemorrhagic complication (bleeding from intestine or extra- intestine). 5, The incidence of VTE on each number of the risk factors. 6, The transition of coagulation/fibrinolytic-associated laboratory data. 7, Site, treatment and outcome in VTE patients.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	UFH is administrated with a subcutaneous injection of 5000 units every 12 hours or intravenous drip infusion of 10000 units for 24 hours. UFH is administered for at least 3 days, and a continuation or completion of administration of UFH since fourth days is judged by doctor in charge, consdering disease activity, reduction of other risks against VTE and so on.
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	1) Patients who are both Male and Female 2) Patients who are Age 20 years and over. 3) Patients who agree with participation of this study by explanation and consent forms 4) To be inpatient
Key exclusion criteria	1) Patients who have 2 or more decrease of hemoglobin concentration within 1 week, or active intestinal bleeding defined as Mayo bleeding score 3 (Intestinal bleeding in Crohn disease is assessed based on Mayo score). Patients with active phase who are assessed as unqualified for antithrombotic therapy by doctor in charge in spite of unmatched above criteria. 2) Patients who are bleeding or have possibility of bleeding, such as peptic ulcer in gastrointestinal tract and hematological disorder having the tendency of bleeding (disseminated intravascular coagulation, idiopathic thrombocytopenic purpura, hemophilia). 3) Patients who have severe hepatic and/or renal dysfunction. 4) Patients who have allergy against UFH. 5) Patients who have the past histories of heparin-induced thromobocytopenia. 6) Patients who take antithrombotic therapy other than UFH, such as antiplatelet drugs, direct oral anticoagulant and low molecular weight heparin. 7) Patients who do not have been diagnosed to be IBD, such as IBD unclassified. 8) Patients who do not agree with participation of this study regardless of explanation and consent forms.
Target sample size	170

Research contact person
Name of lead principal investigator	Mikihiro Fujiya
Organization	Asahikawa Medical University
Division name	Department of medicine, Division of gastroenterology and hematology/oncology
Address	2-1-1-1-, Midorigaoka-Higashi, Asahikawa, Hokkaido, Japan
TEL	0166-68-2462
Email	fjym@asahikawa-med.ac.jp

Public contact
Name of contact person	Katsuyoshi Ando
Organization	Asahikawa Medical University
Division name	Department of Community Medicine Management
Address	2-1-1-1-, Midorigaoka-Higashi, Asahikawa, Hokkaido, Japan
TEL	0166-68-2462
Homepage URL
Email	k-ando@asahikawa-med.ac.jp

Sponsor
Institute	Asahikawa Medical Universtity
Institute
Department

Funding Source
Organization	Asahikawa Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Asahikawa Welfare Hospital Asahikawa City Hospital The participation institute of Intractable Disease Health and Labour Sciences Research, the Ministry of Health, Labour and Welfare
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

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 10 Month 06 Day
Anticipated trial start date	2017 Year 12 Month 01 Day
Last follow-up date	2020 Year 12 Month 31 Day
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	2017 Year 11 Month 05 Day
Last modified on	2017 Year 11 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034075