Warfarin versus Edoxaban for Treatment of Deep Vein Thrombosis (DVT) in Patients with Severe Motor Intellectual Disabilities (SMID)
- Conditions
- Severe Motor and Intellectual Disabilities
- Registration Number
- JPRN-UMIN000024736
- Lead Sponsor
- ational Hospital Organization Yanai Medical Center
- Brief Summary
To investigate the occurrence frequency of deep vein thrombosis (DVT) by the lower extremity venous ultrasonography and the occurrence factor of DVT for children with severe physical and mental disorders, and to investigate the cause of the occurrence of warts of oral anticoagulant warfarin or novel oral anti- The purpose of this study was to evaluate the efficacy and safety of coagulant (NOAC) edoxaban tosilicate hydrate formulation (Lixiana) administered. DVT cases were randomly assigned to two groups, warfarin group and NOAC group, and the occurrence frequency of hemorrhagic events was evaluated as efficacy and the adverse event expression rate was compared as safety evaluation items. Of the 171 total registered cases, 14 cases (8.4%) were DVT cases among 167 patients except DVT unevaluated cases and ineligible cases. Factors related to the presence of DVT were age (OR = 1.09, 95% CI = 1.03 - 1.15). Regarding DVT cases, we compared the warfarin-administered group and the NOAC-administered group, 4 cases in the NOAC group, 0.067 / person-month, 0.067 / person-month for the hemorrhagic event (major bleeding + clinically significant bleeding) which is the main endpoint, the warfarin group Three cases and 0.042 / person-month were not different between the two (p = 0.5383). Regarding the contents of hemorrhagic events (major bleeding + clinically important bleeding), no major bleeding was seen, most of the bleeding accompanying the treatment such as subcutaneous bleeding due to bruises, suction of sputum and so on.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 76
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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