|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT03044041 |
|
Date of registration:
|
29/01/2017 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Comparison Between Low Dose and High Dose Intra-articular Tranexamic Acid in Total Knee Arthroplasty
|
|
Scientific title:
|
Topical Intra-Articular High Doses Compared With Low Doses of Tranexamic Acid to Reduce Blood Loss in Primary Total Knee Arthroplasty: A Double-Blind Randomized Controlled Trial |
|
Date of first enrolment:
|
January 2016 |
|
Target sample size:
|
80 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT03044041 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Thailand
| | | | | | | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Osteoarthritic knee who underwent primary total knee arthroplasty
Exclusion Criteria:
- Abnormal coagulation or bleeding disorder
- Allergy to tranexamic acid
- History of thromboembolism or ischemic heart disease or cerebrovascular accident
- chronic kidney disease stage 3-4
Age minimum:
50 Years
Age maximum:
90 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Blood Loss, Surgical
|
|
Intervention(s)
|
|
Drug: Tranexamic Acid
|
|
Primary Outcome(s)
|
|
Total blood loss
[Time Frame: 72 hours after TKA]
|
|
Secondary Outcome(s)
|
|
Knee ROM
[Time Frame: At 2, 6 weeks after surgery]
|
|
Rate of participants with thromboembolism
[Time Frame: At 72 hours and 2 weeks after surgery]
|
|
Blood transfusion
[Time Frame: 0-72 hours after surgery]
|
|
Rate of participants with infection
[Time Frame: 0-3 months after surgery]
|
|
Functional score
[Time Frame: At 6 weeks after surgery]
|
|
Secondary ID(s)
|
|
OrthoTU08
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|