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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036687
Receipt No. R000041795
Scientific Title The effect of tranexamic acid on perioperative bleeding in patients undergoing total knee or hip arthroplasty
Date of disclosure of the study information 2019/05/09
Last modified on 2019/05/08

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Basic information
Public title The effect of tranexamic acid on perioperative bleeding in patients undergoing total knee or hip arthroplasty
Acronym The effect of tranexamic acid on perioperative bleeding in patients undergoing total knee or hip arthroplasty
Scientific Title The effect of tranexamic acid on perioperative bleeding in patients undergoing total knee or hip arthroplasty
Scientific Title:Acronym The effect of tranexamic acid on perioperative bleeding in patients undergoing total knee or hip arthroplasty
Region
Japan

Condition
Condition osteoarthritis of knee or hip
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Tranexamic acid (TXA) has been used to reduce perioperative bleeding in various surgery because of its antifibrinolytic effect. Recently, the patients undergoing orthopedic surgery in our hospital received a loading dose of TXA (1000 mg) before surgery followed by 100 mg/hour until the end of surgery. The purpose of this retrospective study is to evaluate the efficacy of TXA administration on the perioperative blood loss in patients undergoing knee arthroplasty or hip arthroplasty.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes amount of intraoperative blood loss, intraoperative infusion volume, intraoperative blood transfusion volume, postoperative blood transfusion volume, the changes of hemoglobin concentrations , and estimated blood loss.
Key secondary outcomes pulmonary embolism, deep vein thrombosis

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 patients who had total knee arthroplasty or total hip arthroplasty
Key exclusion criteria deep vein embolism
pulmonary embolism
Target sample size 135

Research contact person
Name of lead principal investigator
1st name Toru
Middle name
Last name Goyagi
Organization Akita University Graduate School of Medicine, Akita, Japan
Division name Department of Anesthesia and Intensive Care Medicine
Zip code 010-0843
Address 1-1-1, Hondo, Akita
TEL 018-884-6175
Email tgoyagi@doc.med.akita-u.ac.jp

Public contact
Name of contact person
1st name Toru
Middle name
Last name Goyagi
Organization Akita University Graduate School of Medicine, Akita, Japan
Division name Department of Anesthesia and Intensive Care Medicine
Zip code 010-0843
Address 1-1-1, Hondo, Akita
TEL 018-884-6175
Homepage URL
Email tgoyagi@doc.med.akita-u.ac.jp

Sponsor
Institute Akita University
Institute
Department

Funding Source
Organization nil
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 Akita University Graduate School of Medicine, Akita, Japan
Address 1-1-1, Hondo, Akita
Tel 018-833-1166
Email info@hos.akita-u.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
2019 Year 05 Month 09 Day

Related information
URL releasing protocol http://www2.hos.akita-u.ac.jp/chiken/info/pdf/20171120_1862.pdf
Publication of results Unpublished

Result
URL related to results and publications https://myesa.esahq.org/Public/Agenda/Calendar?event=2
Number of participants that the trial has enrolled 135
Results
A total of 135 patients were included during the study period. 63 patients for the control group and 72 patients for the TXA group. The demographic data were similar between the two groups. The intraoperative infusion, the postoperative transfusion, delta Hb, and estimated blood loss were significantly reduced in the TXA group, although there were no significant differences in the volumes of intraoperative transfusion and blood loss.
Results date posted
2019 Year 05 Month 08 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
patients who had total knee or hip arthroplasty
Participant flow
control group; patients who underwent surgery with no tnanexamic acid (from 1 January 2015 to 31 December 2015)
tranexamic acid group; patients who underwent surgery with TXA administration ( from 1 July 2016 to 30 June 2017)
Adverse events
nil
Outcome measures
amount of intraoperative blood loss, intraoperative infusion volume, intraoperative blood transfusion volume, postoperative blood transfusion volume, the changes of hemoglobin concentrations, and estimated blood loss.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 11 Month 01 Day
Date of IRB
2017 Year 11 Month 27 Day
Anticipated trial start date
2017 Year 12 Month 01 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A retrospective review was conducted for the records in patients who underwent surgery without TXA administration (control group, from 1 January 2015 to 31 December 2015) and patients who underwent surgery with TXA administration (TXA group, from 1 July 2016 to 30 June 2017).

Management information
Registered date
2019 Year 05 Month 08 Day
Last modified on
2019 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041795

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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