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

Hospital for Special Surgery (HSS)

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis, Knee

Treatments: Drug: Intravenous saline; Drug: Topical saline; Drug: Topical tranexamic acid; Drug: Intravenous tranexamic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT02540226

2015-210

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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76 participants in 2 patient groups

Intravenous tranexamic acid

Active Comparator group

Description:

Patients will receive 1g tranexamic acid in 100mL solution intravenously in the operating room before inflation of the tourniquet. They will again receive the same IV solution in the post-anesthesia care unit, approximately 3 hours after the first solution was given. They will also receive a 75cc topical saline solution approximately 5 minutes before the tourniquet is released.

Treatment:

Drug: Topical saline

Drug: Intravenous tranexamic acid

Topical tranexamic acid

Experimental group

Description:

Patients will receive 3g tranexamic acid in 75mL solution topically in the operating room, approximately 5 minutes before the tourniquet is released. It will sit for 5 minutes before the solution is suctioned off by the surgeon. They will also receive 2 intravenous saline solutions: one in the operating room before inflation of the tourniquet, and one in the post-anesthesia care unit 3 hours after the first solution was given.

Treatment:

Drug: Topical tranexamic acid

Drug: Intravenous saline