Tranexamic Acid in Reverse Total Shoulder Arthroplasty
Completed · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Shoulder Joint Disease, Complications; Arthroplasty, Intraoperative Complications, Blood Loss, Surgical
In brief
To the Investigators' knowledge, TXA has not been studied in the setting of reverse total shoulder arthroplasty. We propose a double-blinded, randomized, controlled trial comparing perioperative administration of TXA to placebo in the setting of RTSA. The purpose of this study is to examine the efficacy of TXA in reducing overall blood loss and transfusion rates in patients undergoing reverse total shoulder arthroplasty.
Key facts
- Study ID
- NCT02043132
- Run by
- Corewell Health East
- People needed
- 116
- Starts
- 2013-09-01
- Expected to finish
- 2016-02-01
- Last updated by the study team
- 2017-06-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients undergoing scheduled primary reverse total shoulder arthroplasty performed by J. Michael Wiater, MD.
- Patients age 18 and older
You may not qualify if…
- Pregnant* or breast-feeding women
- Allergy to tranexamic acid
- Acquired disturbances of color vision
- Use of estrogen containing medications (i.e. oral contraceptive pills)
- Hormone replacement therapy
- Preoperative anemia [Hemoglobin (Hb) < 11g/dL in females, Hb < 12 g/dL in males]
- Refusal of blood products
- Preoperative use of anticoagulant therapy within 5 days prior to surgery
- Coumadin
- Heparin
- Low molecular weight heparin
- Factor Xa inhibitors
- Thrombin inhibitors
- Coagulopathy
- Thrombophilia
- Antithrombin deficiency
- Factor V Leiden
- Antiphospholipid Syndrome
- Protein C and S deficiency
- History of heparin induced thrombocytopenia
- Sickle cell anemia
- Myeloproliferative disorders
- Platelet < 150,00 mm3
- International Normalized Ratio (INR) > 1.4
- Partial Thromboplastin Time (PTT) > 1.4 times normal
Where it is running
- William Beaumont Hospital — Royal Oak, Michigan, United States
Full record on ClinicalTrials.gov
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