NCT03359525

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

Status unknown Phase 4 Last updated 2 December 2017

What this trial tests

Phase 4 trial testing Tranexamic Acid in Tranexamic Acid Adverse Reaction in 114 participants. Status unknown.

Timeline

1 July 2017

Primary endpoint
30 June 2019

31 December 2019

Quick facts

Lead sponsor	Albany Medical College
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	114
Start date	1 July 2017
Primary completion	30 June 2019
Estimated completion	31 December 2019
Sites	1 location across United States

Drugs / interventions tested

• Tranexamic Acid (Tranexamic Acid) — full drug profile →

Conditions studied

• Tranexamic Acid Adverse Reaction — all drugs for Tranexamic Acid Adverse Reaction →

Sponsor

Albany Medical College

Who can join

Adults 18 to 80, any sex, with Tranexamic Acid Adverse Reaction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Pharmacological interventions for the prevention of bleeding in people undergoing elective hip or knee surgery: a systematic review and network meta-analysis.
   Gibbs VN, Champaneria R, Sandercock J, Welton NJ, et al · · 2024 · cited 19× · PMID 38226724 · DOI 10.1002/14651858.cd013295.pub2