Phase 4
N=640
Randomized Controlled Trial of Tranexamic Acid in Total Knee Arthroplasty: Intravenous vs. Topical
Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT01940523 ↗Enrolled (actual)
640
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Total Blood Loss — 323.59; 271.22 ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Topical Tranexamic Acid (Drug); Intravenous Tranexamic Acid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hospital for Special Surgery, New York
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Blood Loss |
323.59; 271.22 | — |
| SECONDARY Drain Output |
560.13; 456.22 | — |
| SECONDARY The Number Patients Requiring a Transfusion |
2; 6 | — |
Summary
The purpose of this study is to determine whether topical or intravenous administration of tranexamic acid during unilateral total knee replacement is more effective at reducing bleeding in the first 24 hours following surgery. Tranexamic acid is a synthetic drug that has been shown to reduce blood drain output and the need for blood transfusions in both its topical and intravenous forms and is commonly used in orthopedic surgery. We hypothesize that IV and topical administration of tranexamic acid will be equally good at reducing the loss of blood and the need for transfusion immediately following total knee replacement.
Eligibility Criteria
Inclusion Criteria
- Primary total knee replacmeent
- Osteoarthritis
- Unilateral
Exclusion Criteria
- Revision surgery
- Donated preoperative autologous blood
- On chronic anticoagulation medication such as Coumadin, Xarelto, Plavix, or Aspirin (other than 81mg)
- Preoperative hepatic or renal dysfunction
- Diagnosis of inflammatory disease
- Diagnosis of inflammatory arthritis
- Pregnant
- Breastfeeding
- Preoperative hemoglobin 1.4
- Abnormal Partial Thromboplastin Time
- Preoperative platelet count of 1.4
Data sourced from ClinicalTrials.gov (NCT01940523). 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.