Topical Tranexamic Acid (TXA) in Joint Arthroplasty
NCT01937559 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 188
Last updated 2020-05-05
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.
Conditions
- Osteoarthritis
- Hip Arthropathy
- Shoulder Arthropathy
Interventions
- BIOLOGICAL
-
Tranexamic acid (TXA)
1.5g of TXA in 100ml normal saline solution
- DRUG
-
Normal saline
Sponsors & Collaborators
-
The Hawkins Foundation
lead OTHER
Principal Investigators
-
Brian Burnikel, MD · Steadman Hawkins Clinic of the Carolinas - Greenville Health System
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-04-30
- Primary Completion
- 2018-06-30
- Completion
- 2018-11-30
Countries
- United States
Study Locations
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