UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058729 |
|---|---|
| Receipt number | R000067143 |
| Scientific Title | Evaluation of the Predictive Ability and Clinical Utility of D-dimer for Screening Proximal Deep Vein Thrombosis |
| Date of disclosure of the study information | 2025/08/08 |
| Last modified on | 2025/08/07 23:42:59 |
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Basic information
Public title
Evaluation of the Predictive Ability and Clinical Utility of D-dimer for Screening Proximal Deep Vein Thrombosis
Acronym
Screening for Proximal Deep Vein Thrombosis Using D-dimer
Scientific Title
Evaluation of the Predictive Ability and Clinical Utility of D-dimer for Screening Proximal Deep Vein Thrombosis
Scientific Title:Acronym
Screening for Proximal Deep Vein Thrombosis Using D-dimer
Region
| Japan |
Condition
Condition
proximal deep vein thrombosis
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the predictive ability and clinical utility of a screening method using D-dimer for the safe and efficient diagnosis of central (proximal) deep vein thrombosis at the time of hospital admission.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Net benefit in Decision Curve Analysis
Key secondary outcomes
AUC of ROC curve
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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) Patients who were hospitalized at our institution and underwent lower limb venous ultrasonography ordered by the Department of Rehabilitation between October 1, 2019, and September 30, 2023.
2) Patients who had D-dimer levels measured within one week before or after the lower limb venous ultrasonography.
Key exclusion criteria
1) Patients under 20 years of age
2) Patients who declined, or whose family declined, to participate in the study
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Tomioka |
Organization
National Hospital Organization Murayama Medical Center
Division name
Department of Rehabilitation
Zip code
2080011
Address
2-37-1 Gakuen, Musashimurayama-shi, Tokyo, Japan
TEL
042-561-1221
topazshine1124@gmail.com
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Tomioka |
Organization
National Hospital Organization Murayama Medical Center
Division name
Clinical Research Department
Zip code
2080011
Address
2-37-1 Gakuen, Musashimurayama-shi, Tokyo, Japan
TEL
042-561-1221
Homepage URL
topazshine1124@gmail.com
Sponsor or person
Institute
National Hospital Organization Murayama Medical Center (Clinical Research Department)
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Murayama Medical Center (Clinical Research Department)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Murayama Medical Center Institutional Review Board
Address
2-37-1 Gakuen, Musashimurayama-shi, Tokyo, Japan
Tel
042-561-1221
tbonezjp@keio.jp
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
| 2025 | Year | 08 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
273
Results
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
| 2023 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 14 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1) Existing information recorded in inpatient and outpatient electronic medical records (including imaging data) will be extracted, including age, sex, social and lifestyle history, clinical information (past medical history, clinical symptoms, laboratory data, medications, physical findings, imaging findings, presence or absence of surgery, surgical procedures, etc.), rehabilitation details, and activities of daily living (ADL) status.
2) D-dimer values will be extracted from laboratory data.
3) Lower limb venous ultrasound results obtained within 7 days of D-dimer measurement will be recorded.
4)The extracted D-dimer values will be linked with the corresponding lower limb venous ultrasound results.
5)Using spreadsheet or statistical software, the number of true positives, false positives, true negatives, and false negatives for each D-dimer cut-off value, as well as sensitivity and specificity, will be calculated. Analyses such as receiver operating characteristic (ROC) curve and decision curve analysis will be performed.
6) As a secondary analysis, associations between the extracted clinical information, D-dimer values, and lower limb venous ultrasound results will be examined.
Management information
Registered date
| 2025 | Year | 08 | Month | 07 | Day |
Last modified on
| 2025 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067143
