Investigation of Intravenous Tranexamic Acid With Anatomic and Reverse Total Shoulder Arthroplasty

Not Applicable

Completed

• Conditions: Transfusion; Blood Loss; Anatomic Total Shoulder Arthroplasty; Reverse Total Shoulder Arthroplasty; Tranexamic Acid
• Interventions: Drug: Tranexamic Acid; Drug: Placebo

• Registration Number: NCT02569658
• Lead Sponsor: Rush University Medical Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-10-03
• Study First Submitted QC: 2015-10-05
• Study First Posted: 2015-10-07
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Results First Submitted: 2017-04-14
• Results First Submitted QC: 2017-05-20
• Results First Posted: 2017-05-24
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-04
• Last Update Posted: 2021-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Any patient scheduled for a primary anatomic or reverse TSA

Exclusion Criteria

• Allergy to TXA
• Acquired disturbances of color vision
• Pre-op use of anticoagulant therapy within five days before surgery
• History of arterial or venous thromboembolic disease; such as DVT, PE, CVA, TIA
• Pregnancy or breastfeeding
• Recent MI (within 6 months of surgery) or any placement of stent regardless of time since placement
• Renal impairment
• Refusal of blood products
• Any patient undergoing a revision TSA
• Patients who decline to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic Acid Group	Tranexamic Acid	Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.
Placebo Group	Placebo	Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision

Primary Outcome Measures

Name	Time	Method
Post-operative Blood Loss	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.

Secondary Outcome Measures

Name	Time	Method
Number of Units Transfused	Average of 3 days post-operatively	Units of pack red blood cells that the patients recieved
Number of Patients Transfused	Average of 3 days post-operatively	Patients who received a post-op transfusion of pack red blood cells
Number of Participants With Deep Vein Thrombosis	30 days post-operative	Must be diagnosed via ultrasound duplex
Number of Participants With Pulmonary Embolism	30 days post-operative	Must be diagnosed via CT chest or V/Q lung scan
Number of Participants With Stroke	30 days post-operative	Must be diagnosed via CT scan or MRI

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States