Topical Tranexamic Acid (TXA) in Joint Arthroplasty

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2018-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoarthritis Hip Arthropathy Shoulder Arthropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Topical Tranexamic acid (TXA)

Tranexamic acid (TXA) applied topically

Group Type EXPERIMENTAL

Tranexamic acid (TXA)

Intervention Type BIOLOGICAL

1.5g of TXA in 100ml normal saline solution

Saline

Normal saline

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

Tranexamic acid (TXA)

Tranexamic acid (TXA) administered intravenously

Group Type ACTIVE_COMPARATOR

Tranexamic acid (TXA)

Intervention Type BIOLOGICAL

1.5g of TXA in 100ml normal saline solution

Interventions

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Tranexamic acid (TXA)

1.5g of TXA in 100ml normal saline solution

Intervention Type BIOLOGICAL

Normal saline

Intervention Type DRUG

Other Intervention Names

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Cyklokapron

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No