Clinical trial NCT01937559: Topical Tranexamic Acid (TXA) in Joint Arthroplasty
Official title: Topical Application of Tranexamic Acid in Joint Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Hip Arthropathy
Shoulder Arthropathy
Keywords: tranexamic acid (TXA)
Lead sponsor: The Hawkins Foundation
Sponsor class: OTHER
First posted: 2013-09-09
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Post-operative Blood Loss
timeFrame: Duration of hospital stay, up to 4 days
Secondary outcomes:
measure: Number of Participants With Perioperative Blood Transfusions
timeFrame: Duration of hospital stay, up to 4 days
measure: Number of Blood Units Transfused
timeFrame: Duration of hospital stay, up to 4 days
measure: Rate of Surgical Infections
timeFrame: Duration of hospital stay, up to 4 days
measure: Length of Hospital Stay
timeFrame: Duration of hospital stay
measure: Patient-reported Outcomes Scores, Including Euroqol-5D (EQ-5D), Global Rating of Change Scale (GRoC), and Single Alpha Numeric Evaluation (SANE).
timeFrame: 6 months post-surgery
measure: Patient-reported Outcome Scores Including the Harris Hip Score and Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: 6 months after surgery
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Steadman Hawkins Clinic of the Carolinas - Greenville Health System
state: South Carolina
Study officials:
affiliation: Steadman Hawkins Clinic of the Carolinas - Greenville Health System
name: Brian Burnikel, MD
role: PRINCIPAL_INVESTIGATOR
References: