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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036146
Receipt No. R000041178
Scientific Title The hemostatic effect of local injection of tranexamic acid into peri-articular tissue in total knee arthroplasty
Date of disclosure of the study information 2019/03/10
Last modified on 2019/03/10

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Basic information
Public title The hemostatic effect of local injection of tranexamic acid into peri-articular tissue in total knee arthroplasty
Acronym The hemostatic effect of local injection of tranexamic acid into peri-articular tissue in total knee arthroplasty
Scientific Title The hemostatic effect of local injection of tranexamic acid into peri-articular tissue in total knee arthroplasty
Scientific Title:Acronym The hemostatic effect of local injection of tranexamic acid into peri-articular tissue in total knee arthroplasty
Region
Japan

Condition
Condition Osteoarthritis of the knee
Rheumatoid arthritis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to assess the postoperative blood loss and clinical course in the patients undegoing TKA using local injection of TXA by comparing the obtained results with those of drain clamping.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The volume of estimated total blood loss in postoperative day3.
Key secondary outcomes drainage blood volume
Postoperative around the knee circumference
postoperative serum D-dimer level
postoperative compliations

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 In the TXA local injection group, 25ml saline containing of 10 mg/kg TXA was injected into the area around medial,lateral,and posterior capsule, the quadriceps muscle tendon, and the infrapatellar fat pad just prior to incision closure.
Interventions/Control_2 In the drane clamping group,30ml saline containing of 10 mg/kg TXA was injected
was injected immediately after wound closure through a 3.2-mm diameter drain.This tube was clamped and closed completely
for 2 hours, then the clamp was released.
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 Patients undergoing TKA
Key exclusion criteria Patient with a history of thrombosis
Patient with a severe renal disfunction
Patients who need to restart internal anticoagulant as soon as possible postoperatively
Patients deemed inappropriate as research subjects
Target sample size 144

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryosuke Hishimura
Organization Department of Orthopaedic Surgery, Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Division name Orthopaedic Surgery
Zip code
Address North 15 West 7, Kita-Ku, Sapporo 060-8638, Japan
TEL 0117065936
Email ryosukehishimura@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasumitsu Ohkoshi
Organization Department of Orthopedic Surgery, Hakodate Orthopedic Clinic, Japan
Division name Orthopaedic Surgery
Zip code
Address 2-115 Ishikawa-cho, Hakodate, 041-0802, Japan
TEL 0138-34-5700
Homepage URL
Email youhoc1957mykd@gmail.com

Sponsor
Institute Department of Orthopedic Surgery, Hakodate Orthopedic Clinic, Japan
Institute
Department

Funding Source
Organization Department of Orthopedic Surgery, Hakodate Orthopedic Clinic, Japan
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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 函館整形外科クリニック(北海道)、北海道大学病院(北海道)

Other administrative information
Date of disclosure of the study information
2019 Year 03 Month 10 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 Enrolling by invitation
Date of protocol fixation
2019 Year 03 Month 07 Day
Date of IRB
Anticipated trial start date
2019 Year 03 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 03 Month 10 Day
Last modified on
2019 Year 03 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041178

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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