UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036687 |
|---|---|
| Receipt number | 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 23:28:10 |
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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
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
tgoyagi@doc.med.akita-u.ac.jp
Sponsor or person
Institute
Akita University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041795
