Osteoarthritic patients who require hip or knee arthroplasty
Conditions
Interventions
Product Name: Tranexamic acid
Pharmaceutical Form: Tablet
INN or Proposed INN: Tranexamic Acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Product Name: T
Sponsors
Belfast Health and Social Care Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients awaiting primary elective hip or knee replacement in the Primary Joint Unit at Musgrave Park Hospital. 2. Patients greater than or equal to 18 years of age. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 583 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 583
Exclusion criteria
Exclusion criteria: 1.Patients who do not pass a pre-operative assessment for elective total hip or knee arthroplasty (THA/TKA) 2.Fractured neck of femur 3.Haemophiliac or coagulation disorders that require TXA 4.Allergy to tranexamic acid or any of its excipients 5.Platelets less than 75,000/mm3 at pre-operative assessment* 6.Patients on active treatment for venous thromboembolism (VTE) (deep vein thrombosis (DVT), pulmonary embolisms (PE)) within 6 months of surgery* 7.History of VTE within 6 months of surgery* 8.Patients who have had a myocardial infarction (MI) within 12 months* 9.Cardiac stent within 12 months of surgery* 10.Patients who have had a stroke (cerebrovascular accident (CVA)) or transient ischemic attack (TIA) within 9 months of surgery* 11.Anticoagulant use within 7 days of surgery (thienopyridines, clopidogrel etc.* 12.Direct thrombin inhibitors within 2 days of surgery* 13.Xa inhibitors within 2 weeks of surgery* 14.Patients who have stopped Warfarin in preparation for surgery but have an INR level greater than or equal to 1.5* 15.Hepatic failure* 16.Patients with epilepsy 17.Patients requiring therapeutic anticoagulation post-operatively eg. metallic heart valves. 18.Pregnant women, women who have not yet reached the menopause (no menses for = 12 months without an alternative medical cause) who test positive for pregnancy, are unwilling to take a pregnancy test prior to trial entry 19.Patients who have taken the combined oral contraceptive pill within 4 weeks of surgery* 20.Female patients who are breastfeeding 21.Treated with any other investigational medication or device within 60 days 22.Patients unable to provide informed consent 23.Patients who are unable or unwilling to commit to the study schedule of events *These are patients with contra-indications to primary hip or knee replacement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to determine if the use of oral tranexamic acid post-operatively for up to 24h hours will confer a reduction in calculated blood loss at 48 hours beyond an intra-operative intravenous bolus alone for patients undergoing unilateral primary total hip or knee replacement.;Secondary Objective: To determine whether there is any difference between each of the three groups in the study for the following parameters: • Incidence of post-operative haemoglobin falling below the transfusion trigger (irrespective of whether or not the patient was transfusion) prior to discharge • Effect of body mass index (BMI) on the volume of indirect blood loss at 48 hours post-surgery • Change in c-reactive protein from pre-surgery to 48 hours post-surgery • Change in creatinine level from pre-surgery to 48 hours post-surgery • 90 day mortality • 1 year mortality ;Primary end point(s): The primary outcome measure is total indirect blood loss volume in millilitres at 48 hours. This is calculated from the following parameters: Height (m) Weight (kg) Patient sex Pre-operative haematocrit Post-operative haematocrit at 48 hours Volume of blood transfused;Timepoint(s) of evaluation of this end point: 48 hours following knife to skin at the start of a patient's hip or knee replacement. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Incidence of post-operative haemoglobin falling below the transfusion trigger before discharge irrespective of whether or not the patient was transfused •Effect of body mass index on volume of indirect blood loss at 48 hours post-surgery •Change in c-reactive protein from pre-surgery to 48 hours post-surgery •Change in creatinine level from pre-surgery to 48 hours post-surgery •90 day mortality •1 year mortality ;Timepoint(s) of evaluation of this end point: 48 hours post knife to skin: Effect of body mass index on percentage of blood loss, change in c-reactive protein from pre-operative levels, change in creatinine level from pre-operative levels, Discharge from hospital: Incidence of post-operative haemoglobin falling below the transfusion trigger 90 days post surgery: mortality 1 year post surgery: mortality | — |
Countries
United Kingdom
Contacts
Public ContactDavid Beverland
Belfast HSC Trust
Outcome results
None listed