Phase 2
N=21
Tranexamic Acid Dosing for Major Joint Replacement Surgery
Arthroplasty, Replacement, Knee · Arthroplasty, Replacement, Hip
Bottom Line
View on ClinicalTrials.gov: NCT05075200 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Blood Plasma TXA Concentration - Total Body Clearance — 58.0; 116 mL/min
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Tranexamic acid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sunnybrook Health Sciences Centre
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Blood Plasma TXA Concentration - Total Body Clearance |
58.0; 116 | — |
| PRIMARY Blood Plasma TXA Concentration - Area Under the Concentration-time Curve |
31031; 15808 | — |
| PRIMARY Blood Plasma TXA Concentration - Elimination Rate Constant |
0.004; 0.007 | — |
| PRIMARY Blood Plasma TXA Concentration - Volume of Central Compartment |
13.8; 15.9 | — |
| PRIMARY Blood Plasma TXA Concentration - Steady State Volume of Distribution |
20.9; 25.4 | — |
| SECONDARY Intraoperative Blood Loss and Transfusion |
100; 100 | — |
| SECONDARY % Change in Pre- and Postoperative Hemoglobin |
-14.4; -15.1 | — |
| SECONDARY Postoperative Creatinine |
100; 82 | — |
| SECONDARY Postoperative eGFR |
51; 85 | — |
| SECONDARY In-hospital Mortality |
0; 0 | — |
| SECONDARY Hospital Length of Stay |
33.2; 29.6 | — |
Summary
Over 1.7 million hip and knee replacements are performed every year worldwide. These surgeries are associated with high blood loss and transfusion rates. In older patients, the high blood loss can result in postoperative anemia. Anemia is a condition where there is a lack of healthy red blood cells to carry oxygen around the body. This means, the patient may need a blood transfusion. This can result in different immune responses such as lung injury, fluid overload, and sepsis.
The purpose of this study is to find an optimal dose of tranexamic acid (TXA) to be given during a hip or knee replacement surgery. TXA is one of the drugs given during surgery because it lowers the amount of bleeding and the risk of a blood transfusion.
Individuals who are chosen to participate in the study will be split into two separate groups. After anesthesia is administered, study participant will be given the hospitals standard dose of TXA which is 20mg/kg. However, in patients with kidney problems and lower kidney functions, the dose will be lowered because TXA is filtered out of the body through the kidneys. Throughout the surgery and after it, patients will have about 30-50mL (3-5 tablespoons) of blood samples drawn at specific time points. This will be done through IV line which will stay in place during the surgery and post operation to minimize the amount of needle puncturing's.
This study will help to development a new dosing guideline for TXA in patients who are undergoing joint replacement surgery.
Eligibility Criteria
Inclusion Criteria
- Adults > 18 years of age
- Elective unilateral hip or knee joint replacement
Exclusion Criteria
- Contraindication to TXA (e.g., allergy, thrombophilia, tretinoin)
- Advanced liver disease (>2-fold rise in liver enzymes, as this may alter PK analysis)
- Anti-coagulant use within the last 1-4 days prior (depends on anticoagulant, prior to the day of surgery)
Data sourced from ClinicalTrials.gov (NCT05075200). 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.