UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050341 |
|---|---|
| Receipt number | R000057322 |
| Scientific Title | Development of an informative manual on venous thromboembolism |
| Date of disclosure of the study information | 2023/03/01 |
| Last modified on | 2023/02/14 17:59:42 |
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Basic information
Public title
Development of an informative manual on venous thromboembolism
Acronym
Development of an informative manual on venous thromboembolism
Scientific Title
Development of an informative manual on venous thromboembolism
Scientific Title:Acronym
Development of an informative manual on venous thromboembolism
Region
| Japan |
Condition
Condition
Patients admitted to Yokohama City University Hospital
Classification by specialty
| Medicine in general | Cardiology | Nephrology |
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the use of the manual for prevention of venous thromboembolism among inpatients of Yokohama City University Hospital, and to verify the effectiveness of the manual from the perspective of medical safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To examine the utilization rate of the new manual in each department, the number of cases of PTE and the number of bleeding cases and evaluate whether the manual contributes to improving medical safety.
1.Number of cases of PTE
2.Number of bleeding cases
Systemic search is performed on the names of diseases in the electronic medical record, and hand search is also performed.
For the number of bleeding cases, the criteria proposed by BARC (Bleeding Academic Research Consortium) will be used.
Key secondary outcomes
To evaluate the cost-effectiveness of implementing the new manual; compare the number of PTEs and bleeding cases with previous reports to verify if PTEs are reduced and bleeding risk is controlled.
To examine the differences between the groups using and not using the template and collect information on the types and frequency of tests, procedures, and medications used to prevent VTE.
The effects on hospital management will be verified in conjunction with an examination of the status of various additional fees.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria will be considered
1. hospitalized patients who underwent surgery in the operating room.
2. patients with malignant tumors who have a Khorana risk score of 1 or higher and who received chemotherapy during hospitalization
3. stroke inpatients with paralysis in the lower extremities or a Padua prediction score of 4 or higher.
Key exclusion criteria
Patients who are in conflict with any of the following will not be included in this study:
1. Patients undergoing local anesthesia surgery with no ADL restrictions before or after surgery.
2. Patients who have already been anticoagulated preoperatively.
3. Patients in the obstetric field who are pregnant, in labor, or in the postpartum period.
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Shintaro |
| Middle name | |
| Last name | Minegishi |
Organization
Yokohama City University Hospital
Division name
Cardiovascular Medicine
Zip code
236-0004
Address
3-9, Kanazawa, Fukuura, Yokohama
TEL
045-787-2635
minegishi.shi.fb@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Shintaro |
| Middle name | |
| Last name | Minegishi |
Organization
Yokohama City University Hospital
Division name
Cardiovascular Medicine
Zip code
236-0004
Address
3-9, Kanazawa, Fukuura, Yokohama
TEL
045-787-2635
Homepage URL
minegishi.shi.fb@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Hospital
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
Yokohama City University Hospital
Address
3-9, Kanazawa, Fukuura, Yokohama
Tel
045-787-2635
minegishi.shi.fb@yokohama-cu.ac.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
| 2023 | Year | 03 | Month | 01 | 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
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
Preinitiation
Date of protocol fixation
| 2022 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Analysis of the primary endpoint
The rates of PTE occurrence and hemorrhage in eligible hospitalized patients will be calculated. Chi-square test will be used for comparisons among the three groups: surgical cases, malignancy cases, and stroke cases.
Analysis of secondary endpoints
Pearson's chi-square test will be used to examine differences between the template use and non-use groups and to compare proportions between the two groups, including the presence of complications. Logistic regression analysis will be used to adjust for covariates. A t-test will be used to compare means between the two groups, such as length of hospital stay. Analysis of covariance is used to adjust for covariates.
Management information
Registered date
| 2023 | Year | 02 | Month | 14 | Day |
Last modified on
| 2023 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057322
