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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029828
Receipt No. R000034075
Scientific Title Multicenter prospective intervention study to evaluate the efficacy of prophylaxis for venous thromboembolism with antithrombotic drugs in Japanese inflammatory bowel disease inpatients.
Date of disclosure of the study information 2017/12/01
Last modified on 2017/11/05

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Basic information
Public title Multicenter prospective intervention study to evaluate the efficacy of prophylaxis for venous thromboembolism with antithrombotic drugs in Japanese inflammatory bowel disease inpatients.
Acronym Efficacy of prophylaxis for venous thromboembolism with antithrombotic drugs in Japanese IBD inpatients.
Scientific Title Multicenter prospective intervention study to evaluate the efficacy of prophylaxis for venous thromboembolism with antithrombotic drugs in Japanese inflammatory bowel disease inpatients.
Scientific Title:Acronym 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
1st name
Middle name
Last name Mikihiro Fujiya
Organization Asahikawa Medical University
Division name Department of medicine, Division of gastroenterology and hematology/oncology
Zip code
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
1st name
Middle name
Last name Katsuyoshi Ando
Organization Asahikawa Medical University
Division name Department of Community Medicine Management
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2017 Year 10 Month 06 Day
Date of IRB
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

Other
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

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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