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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000020845
Receipt No. 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 2016/02/02

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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
Middle name
Last name Tsukasa Ohmori
Organization Jichi Medical University
Division name Department of Biochemistry
Zip code
Address 3311-1 Yakushiji, Shimotsuke, Tochigi, Japan
TEL 0285-58-7324
Email tohmori@jichi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsukasa Ohmori
Organization Jichi Medical University
Division name Department of Biochemistry
Zip code
Address 3311-1 Yakushiji, Shimotsuke, Tochigi, Japan
TEL 0285-58-7324
Homepage URL
Email tohmori@jichi.ac.jp

Sponsor
Institute Jichi Medical University
Institute
Department

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
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 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
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
2016 Year 02 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024059

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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