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

NCT ID: NCT02540226

Last Updated: 2020-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-19
• Study Completion Date: 2019-12-31

Brief Summary

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intravenous tranexamic acid

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.

Group Type: ACTIVE_COMPARATOR

Intravenous tranexamic acid

Intervention Type: DRUG

Topical saline

Intervention Type: DRUG

Topical tranexamic acid

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.

Group Type: EXPERIMENTAL

Topical tranexamic acid

Intervention Type: DRUG

Intravenous saline

Intervention Type: DRUG

Interventions

Intravenous tranexamic acid

Intervention Type: DRUG

Topical tranexamic acid

Intervention Type: DRUG

Intravenous saline

Intervention Type: DRUG

Topical saline

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital for Special Surgery, New York

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kethy Jules-Elysee, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Locations

Hospital for Special Surgery

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2015-210

Identifier Type: -

Identifier Source: org_study_id