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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024736
Receipt No. R000027767
Scientific Title Warfarin versus Edoxaban for Treatment of Deep Vein Thrombosis (DVT) in Patients with Severe Motor Intellectual Disabilities (SMID)
Date of disclosure of the study information 2016/11/14
Last modified on 2019/01/23

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Basic information
Public title Warfarin versus Edoxaban for Treatment of Deep Vein Thrombosis (DVT) in Patients with Severe Motor Intellectual Disabilities (SMID)
Acronym NHOJ-DVT
Scientific Title Warfarin versus Edoxaban for Treatment of Deep Vein Thrombosis (DVT) in Patients with Severe Motor Intellectual Disabilities (SMID)
Scientific Title:Acronym NHOJ-DVT
Region
Japan

Condition
Condition Severe Motor and Intellectual Disabilities
Classification by specialty
Cardiology Vascular surgery Pediatrics
Laboratory medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Most patients with severe motor and intellectual disabilities (SMID) have restricted mobility capability and have been bedridden for long periods because of paralysis of the extremities caused by abnormal muscular tonicity due to cerebral palsy and developmental disabilities, and such patients thought to be associated with a high risk for the complications of deep vein thrombosis (DVT). In cross sectional study, we examine the incidence and risk factors of DVT in patients with SMID. In an open-label randomized non-inferiority study, we randomly assigned patients with DVT, who have initially received warfarin or edoxaban. As a result, we evaluate the primary safety outcome for major or clinically relevant nonmajor bleeding.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 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
Key secondary outcomes 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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Warfarin group: After diagnosis of DVT, start administration of Warfarin orally.
Interventions/Control_2 Edoxaban group: After diagnosis of DVT, start administration of Edoxaban orally.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key 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
Key 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.
Target sample size 76

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiromitsu Ohmori
Organization National Hospital Organization Yanai Medical Center
Division name Pediatrics
Zip code
Address 95 Ihonosho, Yanai,Yamaguchi, 742-1352, JAPAN
TEL 0820-27-0211
Email h-h.ohmori@sound.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiromitsu Ohmori
Organization National Hospital Organization Yanai Medical Center
Division name Pediatrics
Zip code
Address 95 Ihonosho, Yanai,Yamaguchi, 742-1352, JAPAN
TEL 0820-27-0211
Homepage URL
Email h-h.ohmori@sound.ocn.ne.jp

Sponsor
Institute National Hospital Organization Yanai Medical Center
Institute
Department

Funding Source
Organization National Hospital Organization
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 14 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Target population in the cross sectional study is 200 patients.

Management information
Registered date
2016 Year 11 Month 07 Day
Last modified on
2019 Year 01 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027767

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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