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Topical Tranexamic Acid (TXA) in Joint Arthroplasty

T

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

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)

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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