Rush University Medical Center
Chicago, Illinois, 60612, United States
NCT Number: NCT02569658
To compare intravenous Tranexamic Acid (TXA) versus normal saline placebo to determine whether or not TXA administration reduces blood loss, decrease in hemoglobin, and rate of transfusions following anatomic and reverse total shoulder arthroplasty (TSA) surgeries.
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Interventional
Not applicable
Chicago, Illinois, 60612, United States
Anatomic and reverse total shoulder arthroplasty (TSA) is associated with the risk of moderate to significant blood loss that can lead to transfusions. Average estimated blood loss has been reported in the range of 354 to 361 mL intraoperatively, not accounting for additional postoperative blood loss postoperatively in surgical drains. Transfusion rates have been reported to range from 2.4% to 9.5% in recent studies, with rates over 30% for revision cases. Tranexamic acid (TXA) is a synthetic antifibrinolytic agent that is an established method of reducing blood loss and transfusion requirement for patients undergoing total hip and knee arthroplasty. TXA can be administered intravenously, topically (intraarticularly), or orally, with most available literature addressing intravenous and topical administration. Systematic reviews and meta-analyses of the total hip and knee arthroplasty literature demonstrate approximately a 30% decrease in blood loss and 50% decrease in transfusion rate with topical or intravenous administration of TXA compared to placebo. Moreover, the literature demonstrates no increased rate of thromboembolic or other complications associated with TXA administration for hip and knee arthroplasty.
Despite proven efficacy in the hip and knee arthroplasty literature, there have been no studies analyzing the ability of TXA to reduce blood loss and transfusion rate following TSA.
Purpose of the study is to compare intravenous Tranexamic Acid (TXA) versus normal saline placebo to determine whether or not TXA administration reduces blood loss, decrease in hemoglobin, and rate of transfusions following anatomic and reverse total shoulder arthroplasty (TSA) surgeries. With the hypothesis that intravenous TXA will reduce blood loss following TSA.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Average of 3 days post-operatively
Equated based on the patient's predicted blood volume and change in hemoglobin from the pre-operative level to the lowest post-operative level.
Time frame: Average of 3 days post-operatively
Units of pack red blood cells that the patients recieved
Time frame: Average of 3 days post-operatively
Patients who received a post-op transfusion of pack red blood cells
Time frame: 30 days post-operative
Must be diagnosed via ultrasound duplex
Time frame: 30 days post-operative
Must be diagnosed via CT chest or V/Q lung scan
Time frame: 30 days post-operative
Must be diagnosed via CT scan or MRI
Rush University Medical Center
Other
Investigation of the Blood Sparing Properties of Intravenous Tranexamic Acid With Anatomic and Reverse Total Shoulder Arthroplasty
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