Role of Topical Tranexamic Acid in Total Hip Arthroplasty

Phase 2

Terminated

Brief Summary: Total hip arthroplasty (THA) is a procedure associated with perioperative blood loss, requiring blood transfusions in some patients. The major cause of this blood loss is due to surgical trauma that induces the clotting cascade and fibrinolysis. Several previous studies and meta-analyses have shown that tranexamic acid is an effective antifibrinolytic agent that reduces blood loss in a variety of situations. Tranexamic acid given in an intravenous form has been extensively studied and shown to be efficacious in cardiothoracic, spine surgical procedures as well as total knee arthroplasty (TKA) and THA. Similarly, topical tranexamic acid has been associated with decreased blood loss in cardiac surgeries as well. Recently, results from a prospective randomized study on the topical use of tranexamic acid in total knee arthroplasty found it to be effective for reducing postoperative blood loss. Taking all of the above into consideration we have proposed a study to evaluate effects of topical application of tranexamic acid on postoperative blood loss and blood transfusion on patients undergoing total hip arthroplasty. The aim of this study is to evaluate the efficacy of the topical application of tranexamic acid on blood loss in patients undergoing a primary unilateral total hip arthroplasty.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Known allergy to tranexamic acid
History of any acquired disturbances of color vision
Preoperative anemia on basis of pre-operative lab work up (a hemoglobin value of <11 g/dL in females and <12 g/dL in males)
History of previous myocardial infarction
History of arterial or venous thromboembolic disease
History of fibrinolytic disorders requiring intraoperative antifibrinolytic treatment, coagulopathy in the past and/or as identified by a preoperative platelet count of <150,000/mm3, an international normalized ratio of >1.5, or a prolonged partial thromboplastin time
Pregnancy (h/o any missed menstrual periods in a women of reproductive age group)
Breastfeeding
Refusal of blood products
Preoperative use of anticoagulant therapy within five days before surgery
Medical issues that may pose complications for surgery and would disqualify patient for surgery regardless of clinical trial (e.g. renal and hepatic failure)
Major comorbidities (e.g. severe ischemic heart disease )
Severe pulmonary disease
Preoperative blood donation
Participation in another clinical trial involving pharmaceutical drugs

Arm && Interventions

Group	Intervention	Description
Group 1	Normal Saline Solution	Patients undergo primary total hip arthroplasty and have a wash of 100cc of normal saline applied to the tissues under the skin prior to skin closure. The wash sits in the wound for 5 minutes then is suctioned out and the skin is closed.
Group 2	Tranexamic Acid	Patients undergo primary total hip arthroplasty and have a wash of 100cc of normal saline plus 1.5 g (100 mg/mL)Tranexamic Acid is applied to the tissues under the skin prior to skin closure. The wash sits in the wound for 5 minutes then is suctioned out and the skin is closed.

Primary Outcome Measures

Name	Time	Method
Estimated Blood Loss	Pre Op, Post Op Day 2	Estimated Blood Loss defined as Pre Op Hgb mins the Post Op Day two Hgb.

Secondary Outcome Measures

Name	Time	Method
Harris Hip Scores	6 week	Standardized questionnaire that measures clinical function related to the hip. Total potential range is from 4.0 - 96.0. A higher score indicates a more favorable clinical outcome.
Mid Thigh Circumference	Pre Op	Measurement of the thigh at the half way point between the prominence of the greater trochanter and the lateral epicondyle of the femur. No data recorded at 2 weeks or 6 weeks for this study population.