Topical Tranexamic Acid (TXA) in Joint Arthroplasty

The Hawkins Foundation

Status and phase: Completed; Phase 4

Conditions: Hip Arthropathy; Osteoarthritis; Shoulder Arthropathy

Treatments: Drug: Normal saline; Biological: Tranexamic acid (TXA)

Study type: Interventional

Funder types: Other

Identifiers

NCT01937559

Pro00021253

Details and patient eligibility

About

The objective of this study is to evaluate the efficacy of topical tranexamic acid (TXA) in decreasing blood loss following both shoulder arthroplasty and primary total hip arthroplasty. TXA functions to decrease blood loss by affecting the blood clotting system within the body. The investigators hypothesize that topical application of TXA prior to closure reduces postoperative bleeding as measured by absolute changes in postoperative hemoglobin levels and surgical drain output. In addition, use of topically applied tranexamic acid may reduce the need for transfusions, the rates of hematomas, infections, and length of hospital stay.

Enrollment: 188 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Shoulders: All adult patients over the age of 18 scheduled for a primary total arthroplasty or a primary reverse shoulder arthroplasty will be eligible for inclusion in the study.

Hips: All adult patients over the age of 18 scheduled for a primary total hip arthroplasty will be eligible for inclusion in the study.

Exclusion criteria

• allergy to TXA, refusal of blood products, preoperative use of anticoagulant therapy within 5 days of surgery, history of seizures, renal failure (creatine clearance <30ml/min), bleeding disorders, venous thromboembolism (deep vein thrombosis and/or pulmonary embolism), significant cardiac history (myocardial infarction, angina, stroke, lower limb ischemia), or perioperative anemia (hemoglobin <11g/dl in females and < 12g/dl in males).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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188 participants in 3 patient groups, including a placebo group

Topical Tranexamic acid (TXA)

Experimental group

Description:

Tranexamic acid (TXA) applied topically

Treatment:

Biological: Tranexamic acid (TXA)

Saline

Placebo Comparator group

Description:

Normal saline

Treatment:

Drug: Normal saline

Tranexamic acid (TXA)

Active Comparator group

Description:

Tranexamic acid (TXA) administered intravenously

Treatment:

Biological: Tranexamic acid (TXA)