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

• Status: Unknown status
• Trial end date: 2019-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Brief Summary Title: Prospective Randomized Trial Comparing Topical Versus Intravenous Tranexamic Acid (TXA) in Anterior (Total hip arthroplasty) Several strategies have been used to reduce transfusion requirements during total hip arthroplasty (THA). Recently, anti-fibrinolytic agent TXA, has been used extensively in THAs to minimize intra-operative blood losses. However, few studies have compared the efficacy of topical versus intravenous use in direct anterior THA. Therefore, the investigators will attempt to evaluate differences in the post-operative outcomes of topical versus intravenous TXA in Direct anterior approach to THA. The investigators propose to conduct a prospective randomized study in which patients who have exhausted non-operative treatment for hip osteoarthritis and are opting for THA 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. Patients will be distributed in to 3 groups as follows: Group A: Intravenous TXA at a dose of 1 gram administered 30 min prior to skin incision and 1 gram 3 hours after the procedure. (Total dose: 2 grams) Group B: Topical TXA 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:2 grams) Group C: Combined Intravenous 1 gram given intravenous 30 min prior to skin incision and topical TXA (1 gram) injected into the peri-articular tissues prior to closure. (Total dose: 2 grams). The number of subjects needed to achieve 90% power was calculated based on a one-way fixed effects analysis of variance with 3 levels. Primary endpoint used was drainage measured in milliliters in the post-operative (POD) #1 following surgery. Criterion for significance (alpha) was set at 0.05 and the ANOVA statistics was non-directional (two tailed). Preliminary data indicated that drainage volume averages 250 ml with a standard deviation of 160 ml in our operating room. Difference (maximum to minimum of the three levels) of 150 ml was judged to be the minimally clinically relevant difference in drainage volume (effect size =0.38). A 20% loss to follow up was also assumed. The study will need 38 cases per cell for a total of 114 cases to achieve 90% power of detecting a difference this large. Data metrics will be tabulated into excel spreadsheets. Data analysis will be performed using statistical software. Quantitative data will be analyzed using non-directional analysis of variance (ANOVA) with Tukey's test for multiple comparisons. Non-normality or heteroscedasticity of data will either be corrected by transformation or a non-parametric (Kruskal Wallis) test will be used. Categorical data will be analyzed using chi-square tests (or Fisher's exact test if any cells expected value is 5 or less). A p-value <0.05 will be considered statistically significant.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Albany Medical College
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria

To be eligible to participate in the study, subjects must meet the following criteria:

1. Males or females age > 18 years and <80 years

2. Informed consent

3. Diagnosis of primary osteoarthritis or osteonecrosis

4. Previous history of contralateral hip or knee arthroplasty will not be excluded from the study Exclusion criteria

Subjects who meet any of the following criteria will NOT be eligible to participate in the study:

1. Unable to comply with study requirements i.e unable to complete first follow-up visit at 4 weeks or if they are unable to follow-up.

2. Has an active joint infection\

3. Immuno-suppression, e.g., human immunodeficiency virus (HIV) infection, s/p organ transplantation, receipt of steroids for > 10 days at > 10 mg of prednisone equivalent daily within the 90 days prior to enrollment

4. Chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection

5. Body mass index > 45

6. Life expectancy < 6 months

7. Renal insufficiency (serum creatinine >2.5 mg/dl)

8. Pre-operative Hemoglobin <8 gm/dl

9. Congenital and acquired coagulopathy

10. Patients on pre-operative therapeutic anticoagulation

11. Patients who need post-operative therapeutic anticoagulation

12. Pregnancy and nursing mothers or women who are expected to nurse their babies within one month of surgery

13. History of thromboembolism, stroke, transient ischemic attack, traumatic brain injury, subdural, or subarachnoid hemorrhage

14. History of reported allergy to tranexamic acid

15. Uncontrolled Hypertension

16. Non-steroidal antiinflammatory use within 3 weeks of surgery other than Celebrex.

17. Patients who continue the use of aspirin and have not stopped for more than 7 days prior to surgery.

18. Patients who need to be on any anticoagulation other than aspirin 325 mg BID will be excluded from the study.

19. Prisoners will be excluded from the study.

20. Patients with history of acquired defective color vision

21. Plan for staged bilateral total hip procedures within 14 days

22. Family history of thromboembolism

23. Patient unable to receive spinal anesthesia