Unique ID issued by UMIN | UMIN000029828 |
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Receipt number | 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 10:46:57 |
Multicenter prospective intervention study to evaluate the efficacy of prophylaxis for venous thromboembolism with antithrombotic drugs in Japanese inflammatory bowel disease inpatients.
Efficacy of prophylaxis for venous thromboembolism with antithrombotic drugs in Japanese IBD inpatients.
Multicenter prospective intervention study to evaluate the efficacy of prophylaxis for venous thromboembolism with antithrombotic drugs in Japanese inflammatory bowel disease inpatients.
Efficacy of prophylaxis for venous thromboembolism with antithrombotic drugs in Japanese IBD inpatients.
Japan |
Inflammatory bowel disease
Gastroenterology |
Others
NO
To reveal the efficacy of prophylaxis for venous thromboembolism(VTE) with antithrombotic drugs in Japanese inpatients with inflammatory bowel disease(IBD).
Efficacy
Confirmatory
Pragmatic
Not applicable
The incidence of VTE at 2 weeks after starting administration of unfractionated heparin(UFH) for prophylaxis to inpatients with IBD.
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.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Medicine |
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.
20 | years-old | <= |
Not applicable |
Male and Female
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
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.
170
1st name | |
Middle name | |
Last name | Mikihiro Fujiya |
Asahikawa Medical University
Department of medicine, Division of gastroenterology and hematology/oncology
2-1-1-1-, Midorigaoka-Higashi, Asahikawa, Hokkaido, Japan
0166-68-2462
fjym@asahikawa-med.ac.jp
1st name | |
Middle name | |
Last name | Katsuyoshi Ando |
Asahikawa Medical University
Department of Community Medicine Management
2-1-1-1-, Midorigaoka-Higashi, Asahikawa, Hokkaido, Japan
0166-68-2462
k-ando@asahikawa-med.ac.jp
Asahikawa Medical Universtity
Asahikawa Medical University
Self funding
Asahikawa Welfare Hospital
Asahikawa City Hospital
The participation institute of Intractable Disease Health and Labour Sciences Research, the Ministry of Health, Labour and Welfare
NO
2017 | Year | 12 | Month | 01 | Day |
Unpublished
Preinitiation
2017 | Year | 10 | Month | 06 | Day |
2017 | Year | 12 | Month | 01 | Day |
2020 | Year | 12 | Month | 31 | Day |
2017 | Year | 11 | Month | 05 | Day |
2017 | Year | 11 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034075
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