Severe Motor and Intellectual Disabilities
Conditions
Interventions
Warfarin group: After diagnosis of DVT, start administration of Warfarin orally.
Edoxaban group: After diagnosis of DVT, start administration of Edoxaban orally.
Sponsors
National Hospital Organization Yanai Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult patients with SMID of Oshima's Classification grade 1-4 2) Possible patients undergoing assessment for venous sonography of lower extremities 3) Patients with agreement of legally acceptable guardian
Exclusion criteria
Exclusion criteria: 1) Patients with any condition that, as judged by the investigator, would place the subject at increased risk of harm if he/she participated in the study. 2) Patients with calculated creatinine clearance of less than 15 ml per minute 3)Patients receiving contraindicated agents for study drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Cross sectional Study Incidence of DVT,Risk factors of DVT 2) Open-label Randomaized Trial of DVT Primary End-point Safety Outcome during on-treatment : major or clinically relevant nonmajor bleeding | — |
Secondary
| Measure | Time frame |
|---|---|
| Thrombotic burden assessment including size, location and number of DVT on venous ultrasound -Changes of coagulation markers -Bleeding in routine care for SMID patients -Incidences of adverse event for the study period -Exploratory end point -Frequency of measurement of PT-INR in warfarin group -Frequency of dosage adjustments for warfarin -Time in therapeutic INR range in warfarin group | — |
Countries
Japan
Contacts
Public ContactHiromitsu Ohmori
National Hospital Organization Yanai Medical Center Pediatrics
Outcome results
None listed