Prospective Randomized Study Comparing Topical Versus Intravenous Tranexamic Acid in Anterior Total Hip Arthroplasty

Detailed Description Prospective Randomized Study Comparing Topical versus Intravenous Tranexamic Acid in Anterior Total Hip Arthroplasty A. Study Background and Purpose Hip and knee arthroplasty is one of the most successful procedures for relieving pain and correction of deformity in patients with degenerative arthritis of the hip and knee with approximately 1 million procedures performed every year in the United States. However, these joint replacements are associated with substantial amounts of blood loss varying between 500 and 1,500 milliliters often necessitating allogeneic blood transfusions in the post-operative period. This potentially leads to delays in discharge, physical recovery, and increased complications. In addition, it can escalate the cost of total joint arthroplasties in healthcare organizations. Several strategies have been employed in the past with varying efficacies to reduce transfusion requirements including preoperative autologous donation, erythropoietin use, intra-operative hypotensive anesthesia, fibrin spray, cell salvage, and post-operative auto-transfusions drains. Over the past decade the anti-fibrinolytic agent tranexamic acid, a synthetic analog of the amino acid lysine, has been used extensively in lower extremity arthroplasties to minimize intra-operative blood losses. Tranexamic acid prevents the conversion of plasminogen to plasmin on the surface of fibrin, thereby inhibiting fibrinolysis and reducing blood loss. Despite its almost universal use and documented safety, there is significant controversy regarding the optimal route of administration with several studies documenting equivalent efficacy of intravenous and topical administration, with both routes of administration currently considered standard of care in both hip and knee arthroplasties. Anecdotally, the senior author has found that topical use of tranexamic acid has led to greater post-operative drainage and reduction in hematocrit compared to intravenous use. This may be secondary to the absence of tamponade effect with anterior total hip arthroplasty. However, few studies have compared the efficacy of topical versus intravenous use of this medication in direct anterior total hip arthroplasty. Therefore, in this prospective randomized study, the investigators will attempt to evaluate if there exists any significant difference in the post-operative outcomes of topical versus intravenous tranexamic acid following anterior total hip arthroplasty.

B. Study Design This will be a prospective randomized study in which subjects who have exhausted non-operative treatment for hip osteoarthritis and are opting for total hip arthroplasty will be randomized into 3 groups in a 1:1:1 ratio based on a computer generated algorithm following inclusion and exclusion criteria as described below. The patients will be recruited into the study by the principal investigator from his practice cohort. They will be consented to enroll in to the study by any one of the co-investigators. They will either be recruited in the office at Bone and Joint Center, 1367 Washington Avenue, Albany New York or at Albany Medical Center, 43 New Scotland Avenue on the day of surgery. Patients will be further stratified according to BMI (body mass index) as this may be a confounding variable affecting blood loss. The patients will be distributed in to 3 groups as follows: Group A: Intravenous Tranexamic acid at a dose of 1 gram administered 30 min prior to skin incision and 1 gram 3 hours after the procedure. (Total dose administered is 2 grams); Group B: Topical Tranexamic acid at a dose of 1 gram injected in to the peri-articular tissues prior to closure and 1 gram injected into the joint through the drain following wound closure. (Total dose administered is 2 grams); Group C: Combined Intravenous 1 gram given intravenous 30 min prior to skin incision and topical tranexamic acid (1 gram) injected in to the peri-articular tissues prior to closure. (Total dose administered is 2 grams). Women who are premenopausal will have a pregnancy test prior to total hip arthroplasty as per institutional protocol. This will be covered by the patient's health insurance. Subjects will be assigned a unique identification number. The principal investigators will maintain a list identifying all subjects by their subject identification number and initials. Subjects will be screened at the time of scheduling surgery in the outpatient clinic. Study procedures and information regarding the nature of the study will be reviewed with potential subjects, and written informed consent will be obtained prior to any study-related procedures. Alternatively, patients may be contacted by phone regarding the study. In this case, the study information will be reviewed with the subject over the phone and subjects will be asked to electronically sign a consent form sent via e-mail. Patients will be given a flyer when they are booked for surgery which will briefly outline our study and inform them that they may be contact about the study via telephone. The phone consent will be performed by one of the primary or co-investigators listed on this study. Adobe E-sign software will be used to send subjects a consent form via e-mail after the phone conversation. The patient will be given an opportunity to review the consent document and then the investigator will place a second call to the subject to review any questions or concerns. The subject and the investigator will the electronically sign the consent in succession. The Adobe E-signature software provides a date and time stamp. After the consent is signed by both parties the subject will be provided a copy of the signed consent by email. A copy of the consent will be maintained in a secure network drive provided by Albany Medical Center which will be accessible by the investigators listed on the study. A printed copy of the signed consent will be placed into the patients chart on the date of surgery. A second printed copy will be placed in a locked file cabinet in the preoperative unit at Albany Medical Center. All patients will have the right to voluntarily withdraw from the study. Any intra-operative or post-operative adverse events prior to discharge from the hospital will be recorded.

Other screening procedures are as follows:

i. Review inclusion and exclusion criteria. ii. Collect demographic information including age, sex, weight, height, BMI, American Society of Anesthesiology status, co-morbidities, and medication use.

iii. Record medical history. iv. Collect baseline data with regards to pre-operative hematocrit, creatinine levels, and coagulation profile.