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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000015319 |
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Date of registration:
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12/10/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The efficacy of dabigatran for portal vein thrombosis/Budd-Chiari syndrome
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Scientific title:
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The efficacy of dabigatran for portal vein thrombosis/Budd-Chiari syndrome - The efficacy of dabigatran for portal vein thrombosis/Budd-Chiari syndrome |
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Date of first enrolment:
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2012/06/01 |
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Target sample size:
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20 |
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Recruitment status: |
Recruiting |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017767 |
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Study type:
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Interventional,observational |
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Study design:
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Single arm Non-randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Hitoshi Maruyama |
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Address:
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1-8-1, Inohana, Chuou-ku, Chiba, Japan
Japan |
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Telephone:
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043-222-7171 |
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Email:
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maru-cib@umin.ac.jp |
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Affiliation:
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Chiba University Graduate School of Medicine Gastroenterology and Nephrology |
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Name:
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Hitoshi Maruyama |
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Address:
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1-8-1, Inohana, Chuou-ku, Chiba, Japan
Japan |
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Telephone:
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043-222-7171 |
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Email:
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maru-cib@umin.ac.jp |
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Affiliation:
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Chiba University Graduate School of Medicine Gastroenterology and Nephrology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1) patients with Child-Pugh classification C 2) patients with severe cardiac or pulmonary dysfunction 3) patients with hemoglobin A1c > 6.5 4) patients with treatment history of dabigatran 5) patients who need treatment of dabigatran combined with other anticoagulant or antiplatelet agent 6) patients with creatinine clearance < 50 ml/min 7) patients who have bleeding symptom or hemophliac 8) patients with peptic ulcers 9) patients with history of cerebral bleeding within 6 months 10) patients with epidural catheter 11) patients with use of non-steroidal anti-inflammatory drugs 12) patients with use of P-glycoprotein repressor 13) patients with use of itoraconazole 14) patients using cardiac pacemaker 15) pregnant woman
Age minimum:
20years-old
Age maximum:
70years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Portal vein thrombosis or Budd-Chiari syndrome
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Intervention(s)
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dabigatran
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Primary Outcome(s)
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Therapeutic effect of dabigatran on portal vein thrombosis or Budd-Chiari syndrome
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Secondary Outcome(s)
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1) Safety of dabigatran for portal vein thrombosis or Budd-Chiari syndrome 2) Predictive factors for the therapeutic effect of dabigatran on portal vein thrombosis or Budd-Chiari syndrome 3) Comparison of therapeutic effect between warfarin and dabigatran for portal vein thrombosis or Buddd-Chiari syndrome
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Source(s) of Monetary Support
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Chiba University Graduate School of Medicine, Department of Gastroenterology and Nephrology
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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