Multicenter prospective intervention study to evaluate the efficacy of prophylaxis for venous thromboembolism with antithrombotic drugs in Japanese inflammatory bowel disease 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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000029828

Enrollment

170

Registered

2017-12-01

Start date

2017-12-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory bowel disease

Interventions

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 o

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
The incidence of VTE at 2 weeks after starting administration of unfractionated heparin(UFH) for prophylaxis to inpatients with IBD.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Japan

Contacts

Public ContactKatsuyoshi Ando

Asahikawa Medical University Department of Community Medicine Management

k-ando@asahikawa-med.ac.jp0166-68-2462

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026