None listed
Conditions
Brief 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.
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 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 o
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.
Sponsors
Whangarei Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients undergoing elective shoulder replacements for osteoarthritis
Exclusion criteria
Patients <18 years of age Revision surgery History of joint infection History of bleeding or metabolic disorder History of renal failure History of renal transplant History of myocardial infarction or stroke within the past year Placement of an arterial stent within the past year Preoperative haemoglobin level of <115g/L or haematocrit <35% History of deep venous thrombosis (DVT) or pulmonary embolism (PE) Patients unwilling to accept blood transfusion Patients with allergy to TXA
Outcome results
None listed