Phase 4
N=84
Tranexamic Acid Dosing for Total Joint Arthroplasty
Arthropathy of Hip · Arthropathy of Knee
Bottom Line
View on ClinicalTrials.gov: NCT02584725 ↗Enrolled (actual)
84
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Change in Hemoglobin From Baseline to the First Post-operative Day (POD#1) — 2.15; 2.06; 2.11 g/dl
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tranexamic Acid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hemoglobin From Baseline to the First Post-operative Day (POD#1) |
2.15; 2.06; 2.11 | — |
| SECONDARY Change in Hemoglobin From Baseline to POD#0 |
1.34; 1.30; 1.16 | — |
| SECONDARY Change in Hemoglobin From Baseline to POD#2 |
2.50; 2.59; 2.28 | — |
| SECONDARY Number of Participants Requiring Blood Transfusion From the Intra-operative Period Into the End of POD#2 |
1; 0; 0 | — |
| SECONDARY Total Estimated Intra-operative Blood Loss |
321.43; 322.32; 376.25 | — |
| SECONDARY Volume of Blood in the Surgical Suction Canister at the End of Surgery |
282.50; 283.93; 329.11 | — |
| SECONDARY Count of Participants Able to Sit on Post-Operative Day 1 (POD1) and Post-Operative Day 2 (POD2) |
26; 28; 28; 27; 28; 28 | — |
| SECONDARY Count of Participants Able to Stand on POD1 and POD2 |
25; 28; 27; 28; 28; 28 | — |
| SECONDARY Count of Participants Able to Walk on POD1 and POD2 |
26; 28; 25; 28; 28; 28 | — |
| SECONDARY Visual Analog Scale (VAS) Pain Scores on POD#1 and POD#2 |
5.18; 3.82; 4.36; 4.63; 3.89; 4.32 | — |
| SECONDARY Wellbeing Questionnaire Score on POD#1 and POD#2 |
6.54; 7.71; 7.04; 7.15; 8.04; 7.39 | — |
| SECONDARY Count of Seizure, Transient Ischemic Attack, Stroke, Myocardial Infarction, Deep Venous Thrombosis, and Pulmonary Embolus |
0; 0; 0; 0; 0; 0 | — |
Summary
The purpose of this study is to determine the effect of increasing doses of tranexamic acid (TXA) on limiting blood loss during total knee and total hip arthroplasty as defined by a change in hemoglobin from pre-operative baseline to the first post-operative day.
Eligibility Criteria
Inclusion Criteria
- Patients undergoing primary unilateral total knee arthroplasty or primary unilateral total hip arthroplasty under spinal anesthesia at Columbia University Medical Center/ New York Presbyterian Hospital.
Exclusion Criteria
- Non-English speaking.
- Patient refusal to participate.
- Weight exceeding 100kg.
- Baseline hemoglobin of less than 10.
- Repeat, revision, or bilateral surgery.
- Known sensitivity or allergy to Tranexamic Acid.
- Active intra-vascular clotting.
- History of coagulopathy or congenital thrombophilia.
- Thromboembolic event in the 12 months prior to enrollment.
- Percutaneous coronary intervention requiring a drug eluting stent in the 12 months prior to enrollment.
- History of anticoagulant medication use unless stopped prior to surgery as recommended by and in accordance with the American Society of Regional Anesthesia Guidelines.
- Use of a general anesthetic in the current anesthetic.
- Blood transfusion for a hemoglobin value which deviates from the study's transfusion protocol.
Data sourced from ClinicalTrials.gov (NCT02584725). 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.