Investigation of Intravenous Tranexamic Acid With Anatomic and Reverse Total Shoulder Arthroplasty
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| ClinicalTrials.gov Identifier: NCT02569658 |
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Recruitment Status :
Completed
First Posted : October 7, 2015
Results First Posted : May 24, 2017
Last Update Posted : November 2, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Blood Loss Anatomic Total Shoulder Arthroplasty Reverse Total Shoulder Arthroplasty Transfusion Tranexamic Acid | Drug: Tranexamic Acid Drug: Placebo | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 110 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Investigation of the Blood Sparing Properties of Intravenous Tranexamic Acid With Anatomic and Reverse Total Shoulder Arthroplasty |
| Study Start Date : | September 2015 |
| Actual Primary Completion Date : | April 2017 |
| Actual Study Completion Date : | April 2017 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Tranexamic Acid Group
Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.
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Drug: Tranexamic Acid |
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Placebo Comparator: Placebo Group
Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision
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Drug: Placebo |
- Post-operative Blood Loss [ 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.
- Number of Units Transfused [ Time Frame: Average of 3 days post-operatively ]Units of pack red blood cells that the patients recieved
- Number of Patients Transfused [ Time Frame: 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 [ Time Frame: 30 days post-operative ]Must be diagnosed via ultrasound duplex
- Number of Participants With Pulmonary Embolism [ Time Frame: 30 days post-operative ]Must be diagnosed via CT chest or V/Q lung scan
- Number of Participants With Stroke [ Time Frame: 30 days post-operative ]Must be diagnosed via CT scan or MRI
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02569658
| United States, Illinois | |
| Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| Principal Investigator: | Gregory Cvetanovich, MD | Rush University Medical Center |
Documents provided by Rush University Medical Center:
| Responsible Party: | Rush University Medical Center |
| ClinicalTrials.gov Identifier: | NCT02569658 |
| Other Study ID Numbers: |
Rush TXA TSA |
| First Posted: | October 7, 2015 Key Record Dates |
| Results First Posted: | May 24, 2017 |
| Last Update Posted: | November 2, 2021 |
| Last Verified: | October 2021 |
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Hemorrhage Pathologic Processes Tranexamic Acid Antifibrinolytic Agents |
Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants |