UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020845 |
|---|---|
| Receipt number | R000024059 |
| Scientific Title | Development of Monitoring Method to Reduce Bleeding Complication by New Anticoagulant Drugs in Orthopedic Surgery |
| Date of disclosure of the study information | 2016/02/02 |
| Last modified on | 2021/02/04 09:56:20 |
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Basic information
Public title
Development of Monitoring Method to Reduce Bleeding Complication by New Anticoagulant Drugs in Orthopedic Surgery
Acronym
A Cohort Study to Develop Monitoring Method to Reduce Bleeding Complication by New Anticoagulant Drugs in Orthopedic Surgery
Scientific Title
Development of Monitoring Method to Reduce Bleeding Complication by New Anticoagulant Drugs in Orthopedic Surgery
Scientific Title:Acronym
A Cohort Study to Develop Monitoring Method to Reduce Bleeding Complication by New Anticoagulant Drugs in Orthopedic Surgery
Region
| Japan |
Condition
Condition
High risk patients for deep vein thrombosis after orthopedic surgery
Classification by specialty
| Orthopedics | Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify laboratory parameters and patient characteristics to increase bleeding volume during orthopedic surgery with new anticoagulant drug.
Basic objectives2
Others
Basic objectives -Others
To assess correlation between bleeding volume and laboratory tests for blood coagulation.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Bleeding volume after orthopedic surgery
Key secondary outcomes
Thromboembolism 1 year after surgery
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) High risk patient for deep vein thrombosis after orthopedic surgery (a guideline by The Japanese Orthopedic Association).
2) The patient can provide informed consent to enroll the study.
Key exclusion criteria
1) Malignancy or suspected malignancy
2) Blood platelet count <= 100,000/microL
3) Congenital bleeding tendency
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tsukasa |
| Middle name | |
| Last name | Ohmori |
Organization
Jichi Medical University
Division name
Department of Biochemistry
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke, Tochigi, Japan
TEL
0285-58-7324
tohmori@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Tsukasa |
| Middle name | |
| Last name | Ohmori |
Organization
Jichi Medical University
Division name
Department of Biochemistry
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke, Tochigi, Japan
TEL
0285-58-7324
Homepage URL
tohmori@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Cardiovascular Research Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Yamanashi Prefectural Central Hospital
Name of secondary funder(s)
Jichi Medical University
IRB Contact (For public release)
Organization
Jichi Medical University
Address
3311-1 Yaskushiji, Shimotsuke, Tochigi, Japan
Tel
0285-44-2111
rinri@jichi.acjp
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
自治医科大学附属病院（栃木県）Jichi Medical University Hospital (Tochigi)，
山梨県立中央病院（山梨県）Yamanashi Prefectural Central Hospital (Yamanashi)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 02 | 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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 10 | Month | 23 | Day |
Date of IRB
| 2012 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2012 | Year | 10 | Month | 23 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, we measure several plasma markers for blood coagulation and fibrinolysis in orthopedic patients treated with anticoagulant therapy because of high-risk for venous thromboembolism. Bleeding is assessed by bleeding volume from drain, changes of hemoglobin, and need for transfusion. Further, the incidence of thromboembolism was assessed 1 year after the surgery. Correlations between bleeding (or thromboembolism) and laboratory tests are assessed to identify a new marker to predict complications.
Management information
Registered date
| 2016 | Year | 02 | Month | 02 | Day |
Last modified on
| 2021 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024059
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