Effect of Topical and Intravenous Tranexamic Acid (TXA) on Thrombogenic Markers in Patients Undergoing Knee Replacement

Completed · Phase 4

Conditions studied: Osteoarthritis, Knee

In brief

Tranexamic acid (TXA) is a drug that is being used more frequently at the Hospital for Special Surgery to lessen the amount of blood loss after total knee replacement (TKR). It is an anti-fibrinolytic agent, which means that it promotes the formation of blood clots. TXA can be given either intravenously or topically (placed directly on the open wound) before wound closure. Patients with certain medical conditions have been found to have a high risk of thrombosis after being given intravenous TXA, which may lead to serious complications. However, to date, no high-risk patients have been identified for use of topical TXA. This study will look at thrombogenic markers (proteins found in blood that promote clot formation) after TXA is given either intravenously or topically. If the effect on these markers is similar between intravenous and topical use of TXA, then the safety of topical TXA should be questioned. Of note, these markers have never been measured after TXA has been given topically. As a result, this information would be important for the medical community.

Key facts

Study ID

NCT02540226

Run by

Hospital for Special Surgery, New York

People needed

76

Starts

2015-11-19

Expected to finish

2019-12-01

Last updated by the study team

2020-03-25

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients undergoing primary unilateral total knee replacement with a participating surgeon
• Patients aged 18-80

You may not qualify if…

• All patients on steroid therapy regardless of dose, duration, or treatment or those requiring stress-dose steroids preoperatively
• Patients who will require postoperative use of Coumadin, Xarelto, or Plavix
• Use of non-steroidal anti-inflammatory drugs (NSAIDs) within 1 week of surgery
• Hypersensitivity to tranexamic acid
• Renal dysfunction (Creatinine clearance < 40 ml/min)
• Hepatic dysfunction (AST or ALT 2x upper limit of normal)
• Cardiac exclusions: coronary stent, history of myocardial infarction, positive stress test, atrial fibrillation, advanced coronary artery disease
• Advanced chronic obstructive pulmonary disease or advanced interstitial lung disease
• History of venous thromboembolism
• Hypercoagulability (e.g. antiphospholipid syndrome, genetic hypercoagulability with or without prior venous thromboembolism)
• History of stroke or transient ischemic attack

Where it is running

• Hospital for Special Surgery — New York, New York, United States

Full record on ClinicalTrials.gov

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