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The investigators propose a double-blinded randomized study evaluating the effectiveness of tranexamic acid in reducing postoperative swelling and haematoma formation after the Latarjet procedure.
The purpose of this study is to assess the efficacy of tranexamic acid (TXA), given via intra-articular injection at the time of surgery in patients undergoing the Latarjet procedure for shoulder instability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Tranexamic Acid 1g IV |
|
| Group B | Placebo Comparator | Saline injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | 1g Tranexamic acid prior to skin incision |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Hematoma Formation | Patients hematoma formation will be evaluated using the Pauzenberger criteria (Grade 1-4) | Postoperative day-1 |
| Visual Analogue Scale | Postoperative day-1 | |
| Total Drain output | The total drain output of blood post-operatively | Postoperative day-1 |
| Opioid consumption | Postoperative day-1 |
| Measure | Description | Time Frame |
|---|---|---|
| Wound complications | Postoperative week-2 | |
| Total complications | Postoperative month-4 | |
| Haematoma Formation |
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Inclusion Criteria:
• Anterior shoulder instability, warranting the Latarjet procedure
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hannan Mullett, FRCSI | Sports Surgery Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sports Surgery Clinic | Santry | Dublin | 9 | Ireland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26480877 | Background | Gillespie R, Shishani Y, Joseph S, Streit JJ, Gobezie R. Neer Award 2015: A randomized, prospective evaluation on the effectiveness of tranexamic acid in reducing blood loss after total shoulder arthroplasty. J Shoulder Elbow Surg. 2015 Nov;24(11):1679-84. doi: 10.1016/j.jse.2015.07.029. | |
| 28768785 | Background |
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| ID | Term |
|---|---|
| D006406 | Hematoma |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Double-blinded randomized
| Saline |
| Drug |
Equivalent volume of saline prior to skin incision |
|
| Postoperative week-2 |
| Pauzenberger L, Domej MA, Heuberer PR, Hexel M, Grieb A, Laky B, Blasl J, Anderl W. The effect of intravenous tranexamic acid on blood loss and early post-operative pain in total shoulder arthroplasty. Bone Joint J. 2017 Aug;99-B(8):1073-1079. doi: 10.1302/0301-620X.99B8.BJJ-2016-1205.R1. |
| 28162887 | Background | Vara AD, Koueiter DM, Pinkas DE, Gowda A, Wiater BP, Wiater JM. Intravenous tranexamic acid reduces total blood loss in reverse total shoulder arthroplasty: a prospective, double-blinded, randomized, controlled trial. J Shoulder Elbow Surg. 2017 Aug;26(8):1383-1389. doi: 10.1016/j.jse.2017.01.005. Epub 2017 Feb 3. |
| 28902659 | Background | Kirsch JM, Bedi A, Horner N, Wiater JM, Pauzenberger L, Koueiter DM, Miller BS, Bhandari M, Khan M. Tranexamic Acid in Shoulder Arthroplasty: A Systematic Review and Meta-Analysis. JBJS Rev. 2017 Sep;5(9):e3. doi: 10.2106/JBJS.RVW.17.00021. |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |