Phase 4
N=150
Tranexamic Acid in Knee Joint Surgery
Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT02278263 ↗Enrolled (actual)
150
Serious AEs
2.2%
Results posted
May 2020
Primary outcome: Primary: Blood Loss — 1090; 716; 746 mls — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tranexamic Acid (Drug); Normal saline (0.9% NaCl) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Andrew G Hill, MBChB, MD (Thesis), EdD, FACS, FRACS
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Blood Loss |
1090; 716; 746 | <0.05 sig |
| SECONDARY Number of Participants Experiencing Symptomatic Venothromboembolic (VTE) Disease |
0; 0; 0; 0; 2; 1 | — |
| SECONDARY Number of Participants Receiving Allogenic Blood Transfusion |
2; 1; 0 | — |
| SECONDARY Length of Stay (LOS) |
4; 4; 4 | — |
| SECONDARY Range of Passive Flexion |
65; 74; 68; 76; 81; 80 | — |
| SECONDARY Range of Active Flexion |
57; 65; 58; 71; 75; 72 | — |
| SECONDARY Perioperative Fluid Administration |
1765; 1613; 1807 | — |
Summary
Total knee joint replacement surgery can lead to significant blood loss, which can affect recovery after surgery. Tranexamic acid (TXA) is a medication which stops the breakdown of blood clots and therefore prevents blood loss. The optimal use of TXA remains a point of debate. Growing interest in the topical application of TXA (directly into the surgical wound) has been suggested as an alternative way of administering TXA, and may demonstrate similar effectiveness as when it is given intravenously. Therefore, this multicentred, randomized controlled trial, aims to investigate the safety and effectiveness of both topical and intravenous administrations of TXA in total knee joint surgery. The investigators predict that both routes of administration will demonstrate similar results when compared to placebo.
Eligibility Criteria
Inclusion Criteria
- All patients at the participating sites on the waiting list for a unilateral total knee joint replacement
Exclusion Criteria
- Patients with a history or risk of thrombosis
- Active thromboembolic disease such as deep vein thrombosis, pulmonary embolism and cerebral thrombosis
- Subarachnoid haemorrhage
- Hypersensitivity to tranexamic acid or any of its ingredients.
- Refusal of blood products
- Colour blindness
- Complex hematologic disorders requiring manipulation
- Coagulopathy
- Pregnant and Lactating Women
- Anti-coagulant therapy pre-operatively within 5 days of surgery (warfarin, dabigatran, heparin)
- Severe renal failure (eGFR <29)
Data sourced from ClinicalTrials.gov (NCT02278263). 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.