Efficacy of Intravenous Versus Topical Tranexamic Acid in Primary Total Hip Arthroplasty

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Bleeding during and after total hip replacement surgery is a primary concern to the surgical and anaesthetic team. Tranexamic acid is a commonly-used drug that helps blood clotting and decreases surgical bleeding. The investigators commonly administer the drug intravenously prior to the procedure. Some patients are unable to receive the drug in this form, because of risks related to blood clotting. The investigators know, from studies in total knee replacement surgery, that the investigators can deliver tranexamic acid directly to the surgical site (topically), with similar benefits and less of the drug absorbed into the bloodstream, resulting in less risk to the patient. The investigators seek to find if similar benefit in terms of reducing blood loss is seen using topical tranexamic acid in hip replacement surgery. The investigators' hypothesis is that the topical form will be equivalent, but not better than the intravenous form for reducing intra- and postoperative bleeding. The investigators also expect to see decreased levels of tranexamic acid in the bloodstream when it is administered topically.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lawson Health Research Institute
• Collaborator: University of Western Ontario, Canada
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

• Primary elective total hip arthroplasty

• Cementless total hip implant system

• Candidate for administration of TEA (as per the LHSC Perioperative Blood Conservation Program Medical Directive titled Preoperative Written Order for Tranexamic Acid in Orthopaedic Surgery)

• Fitness for surgery confirmed after Pre-Admission Clinic appointment

• Consent for transfusion of blood or blood-related products obtained at time of Pre-Admission Clinic appointment.

• Ability to read and understand the English language

Exclusion Criteria:

• Not deemed medically fit for major orthopaedic surgery

• Revision total hip arthroplasty

• Non-elective indication for total hip arthroplasty

• History of thrombotic vascular event (VTE) in the previous 12 months, or requiring lifelong anticoagulation related to previous VTE. VTE is defined as cerebrovascular event (stroke, transient ischemic attack), deep vein thrombosis, and pulmonary embolism

• Consent for transfusion of blood or blood-related products not obtained

• History of developmental hip dysplasia in the operative hip

• History of Legg-Calve-Perthes disease in the operative hip

• Documented allergy to TEA, or to any of its constituent agents

• Unable to participate in scheduled follow-up appointments.