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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic Acid Group | Experimental | Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision. |
|
| Placebo Group | Placebo Comparator | Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Blood Loss | Equated based on the patient's predicted blood volume and change in hemoglobin from the pre-operative level to the lowest post-operative level. | Average of 3 days post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Units Transfused | Units of pack red blood cells that the patients recieved | Average of 3 days post-operatively |
| Number of Patients Transfused | Patients who received a post-op transfusion of pack red blood cells |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory Cvetanovich, MD | Rush University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24986694 | Background | Saltzman BM, Chalmers PN, Gupta AK, Romeo AA, Nicholson GP. Complication rates comparing primary with revision reverse total shoulder arthroplasty. J Shoulder Elbow Surg. 2014 Nov;23(11):1647-54. doi: 10.1016/j.jse.2014.04.015. Epub 2014 Jun 28. | |
| 23927910 | Background | Chalmers PN, Gupta AK, Rahman Z, Bruce B, Romeo AA, Nicholson GP. Predictors of early complications of total shoulder arthroplasty. J Arthroplasty. 2014 Apr;29(4):856-60. doi: 10.1016/j.arth.2013.07.002. Epub 2013 Aug 6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tranexamic Acid Group | Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision. Tranexamic Acid |
| FG001 | Placebo Group | Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 16, 2015 |
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| Average of 3 days post-operatively |
| Number of Participants With Deep Vein Thrombosis | Must be diagnosed via ultrasound duplex | 30 days post-operative |
| Number of Participants With Pulmonary Embolism | Must be diagnosed via CT chest or V/Q lung scan | 30 days post-operative |
| Number of Participants With Stroke | Must be diagnosed via CT scan or MRI | 30 days post-operative |
| 24090984 | Background | Gupta AK, Chalmers PN, Rahman Z, Bruce B, Harris JD, McCormick F, Abrams GD, Nicholson GP. Reverse total shoulder arthroplasty in patients of varying body mass index. J Shoulder Elbow Surg. 2014 Jan;23(1):35-42. doi: 10.1016/j.jse.2013.07.043. Epub 2013 Sep 30. |
| 24751531 | Background | Shields E, Iannuzzi JC, Thorsness R, Noyes K, Voloshin I. Perioperative complications after hemiarthroplasty and total shoulder arthroplasty are equivalent. J Shoulder Elbow Surg. 2014 Oct;23(10):1449-53. doi: 10.1016/j.jse.2014.01.052. Epub 2014 Apr 18. |
| 22623147 | Background | Yang ZG, Chen WP, Wu LD. Effectiveness and safety of tranexamic acid in reducing blood loss in total knee arthroplasty: a meta-analysis. J Bone Joint Surg Am. 2012 Jul 3;94(13):1153-9. doi: 10.2106/JBJS.K.00873. |
| 23651507 | Background | Gandhi R, Evans HM, Mahomed SR, Mahomed NN. Tranexamic acid and the reduction of blood loss in total knee and hip arthroplasty: a meta-analysis. BMC Res Notes. 2013 May 7;6:184. doi: 10.1186/1756-0500-6-184. |
| 24196467 | Background | Alshryda S, Mason J, Sarda P, Nargol A, Cooke N, Ahmad H, Tang S, Logishetty R, Vaghela M, McPartlin L, Hungin AP. Topical (intra-articular) tranexamic acid reduces blood loss and transfusion rates following total hip replacement: a randomized controlled trial (TRANX-H). J Bone Joint Surg Am. 2013 Nov 6;95(21):1969-74. doi: 10.2106/JBJS.L.00908. |
| 24196466 | Background | Alshryda S, Mason J, Vaghela M, Sarda P, Nargol A, Maheswaran S, Tulloch C, Anand S, Logishetty R, Stothart B, Hungin AP. Topical (intra-articular) tranexamic acid reduces blood loss and transfusion rates following total knee replacement: a randomized controlled trial (TRANX-K). J Bone Joint Surg Am. 2013 Nov 6;95(21):1961-8. doi: 10.2106/JBJS.L.00907. |
| 23881695 | Background | Ker K, Beecher D, Roberts I. Topical application of tranexamic acid for the reduction of bleeding. Cochrane Database Syst Rev. 2013 Jul 23;2013(7):CD010562. doi: 10.1002/14651858.CD010562.pub2. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Tranexamic Acid Group | Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision. Tranexamic Acid |
| BG001 | Placebo Group | Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision Placebo |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| operative time | Mean | Standard Deviation | minutes |
| |||||||||||||||
| reverse total shoulder arthroplasty | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Post-operative Blood Loss | Equated based on the patient's predicted blood volume and change in hemoglobin from the pre-operative level to the lowest post-operative level. | Posted | Mean | Standard Deviation | mL | Average of 3 days post-operatively |
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| Secondary | Number of Units Transfused | Units of pack red blood cells that the patients recieved | Posted | Number | Units of PRBCs | Average of 3 days post-operatively |
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| Secondary | Number of Patients Transfused | Patients who received a post-op transfusion of pack red blood cells | Posted | Count of Participants | Participants | Average of 3 days post-operatively |
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| Secondary | Number of Participants With Deep Vein Thrombosis | Must be diagnosed via ultrasound duplex | Posted | Count of Participants | Participants | 30 days post-operative |
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| Secondary | Number of Participants With Pulmonary Embolism | Must be diagnosed via CT chest or V/Q lung scan | Posted | Count of Participants | Participants | 30 days post-operative |
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| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Stroke | Must be diagnosed via CT scan or MRI | Posted | Count of Participants | Participants | 30 days post-operative |
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30 days post-operative
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tranexamic Acid Group | Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision. Tranexamic Acid | 0 | 52 | 0 | 52 | 0 | 52 |
| EG001 | Placebo Group | Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision Placebo | 0 | 56 | 1 | 56 | 0 | 56 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DVT | Vascular disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yale Fillingham | Rush University Medical Center | 3095310220 | yale.fillingham@gmail.com |
| Oct 4, 2021 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 16, 2015 | Oct 4, 2021 | ICF_001.pdf |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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