Phase 3
Completed N=65
Weighted Versus Uniform Dose of Tranexamic Acid in Patients Undergoing Primary, Knee Arthroplasty
Osteoarthritis · Intraoperative Bleeding
Source: ClinicalTrials.gov NCT01651806 ↗
Enrolled (actual)
65
Serious AEs
3.1%
Results posted
Dec 2017
Primary outcomePrimary: Primary Intra-operative Blood Loss — 100.00; 65.00; 142.80; 100.00 mL
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Hypotheses: Primary - A weighted dose of 20 mg/kg of tranexamic acid will be more efficacious than a single uniform dose of 1 gram in primary total knee arthroplasty (TKA) cases. This includes having a greater impact on decreasing blood loss without increasing the occurrence of adverse thromboembolic events in patients undergoing primary, elective total knee arthroplasty.
Secondary - TA will decrease blood loss more effectively in women than in men undergoing this procedure.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Intra-operative Blood Loss |
100.00; 65.00; 142.80; 100.00; 65.00 | — |
| PRIMARY Document Incidences of DVT and Other Thromboembolic Events. |
1; 1; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must be male or female of any race
- Ages 18-80 years old
- Patients must be undergoing an elective, primary knee arthroplasty
- Patients must be able to understand and willing to cooperate with study procedures
- Patients must be able to provide written and verbal informed consent
Exclusion Criteria
- Allergy or intolerance to the study materials
- History of a venous thromboembolic event being treated with life-long anticoagulation
- Patients with a known congenital thrombophilia
- Patients who have had a venous thromboembolic event within the 12 months preceding surgery
- History of any substance abuse or dependence within the last 6 months
- Failure in collecting a required data point during study
- Those patients not indicated for knee replacement surgery including, pregnant women, those not cleared medically for the procedure and patients without significant radiographic evidence of degenerative joint disease.
- Patient using autologous blood transfusion
Data sourced from ClinicalTrials.gov (NCT01651806). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.