RecruitingPhase 4ACTRN12617000918325

In patients having shoulder replacement surgeries, is there any difference in giving tranexamic acid orally or intravenously for minimising bleeding during surgery?

A Prospective Randomised Blinded Controlled Trial Comparing Oral vs Intravenous Administration of Tranexamic Acid in Total Anatomic and Reverse Shoulder Arthroplasty.

Sponsor

Whangarei Hospital

Enrollment

80 participants

Start Date

Aug 29, 2017

Study Type

Interventional

Conditions

Osteoarthritis Shoulder Arthritis

Summary

Tranexamic acid (TXA) functions to decrease blood loss by affecting the blood clotting system within the body. Perioperative administration of TXA in the context of shoulder arthroplasty has been shown to decrease perioperative blood loss compared to placebo in four studies. One prospective, randomised, controlled study (Vara et al, 2017) and two retrospective studies (Abildgaard et al, 2016; Friedman et al, 2016) demonstrated efficacy of intravenous TXA compared with placebo in reducing blood loss in shoulder arthroplasty. Furthermore, another prospective, randomised, controlled study showed efficacy of topical administration of 2g of TXA at the completion of the case compared with placebo (Gillespie et al, 2015). Recently, oral administration of TXA has been shown to be equally as effective for minimising blood loss following total hip arthroplasty (Kayupov et al, 2017). However, to our knowledge, there is no information in the literature comparing the difference in the route of administration of TXA in reducing blood loss following total shoulder arthroplasty. The aim of this study is to compare the efficacy of intravenous administration of TXA with oral infiltration of TXA in decreasing blood loss following total anatomic and reverse shoulder arthroplasties.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing two ways of giving a blood-clot-prevention medicine called tranexamic acid (TXA) before shoulder replacement surgery — one given as a pill by mouth and one given through a vein (intravenously). TXA helps reduce blood loss during surgery. This approach has been shown to work well for hip replacement surgery, but no one has compared pill versus IV forms specifically for shoulder replacement surgery. You may be eligible if: - You are 18 years old or older - You are scheduled for a planned (elective) shoulder replacement for osteoarthritis You may NOT be eligible if: - You are under 18 years old - You are having revision (repeat) shoulder surgery - You have a history of joint infection - You have a bleeding disorder or metabolic condition - You have kidney failure or have had a kidney transplant - You had a heart attack or stroke within the past year - You had an arterial stent placed within the past year - Your blood count (haemoglobin) is below 115 g/L before surgery - You have had deep vein thrombosis (DVT) or pulmonary embolism (PE) - You refuse blood transfusion - You are allergic to TXA Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Intervention: Tranexamic Acid (TXA) Intravenous TXA group: 1. Two hours prior to the surgical procedure, four placebo tablets (vitamin tablet) is given orally to the patient. 2. Following induction

Intervention: Tranexamic Acid (TXA) Intravenous TXA group: 1. Two hours prior to the surgical procedure, four placebo tablets (vitamin tablet) is given orally to the patient. 2. Following induction of anaesthesia, 1.5g of TXA is given intravenously with 10mLs of normal saline solution as a bolus. The half life of TXA is 2 hours. Therefore, repeated dosing during surgery is not required. Oral TXA group: 1. Two hours prior to the surgical procedure, 2g of TXA (4 tablets of 500mg each) is given orally to the patient. 2. Following induction of anaesthesia, 10mL of normal saline is injected intravenously as a bolus. Adherence: The intravenous drug/saline will be administered while the patient is asleep under anaesthesia. Therefore adherence will be 100%. The oral drug/placebo will be administered by a nurse 2 hours prior to the procedure and the nurse will ensure the medications are taken by the patient.