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

NCT03359525 | Unknown Phase 4 FDA Drug

• 1 other identifier: 4744
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tranexamic Acid Adverse Reaction

Outcome Measures

Primary Outcomes (1)

• Post-operative drain output

  This will be measured from the drain output recorded over 24 hours on Post-operative day 1. This is a one time measurement for every participant enrolled in to the study.

  Drain output will be measured in milliliters on Post-operative Day 1 following total hip arthroplasty . This will be a one time measurement for every participant enrolled in the study.

Secondary Outcomes (10)

• Change in post operative hemoglobin

  Post-operative day 1 and day 2 hemoglobin change compared to pre-operative hemoglobin.

• Allogeneic blood transfusion rates

  Measured in the number of participants had transfusion during first week following total hip arthroplasty

• Readmissions

  Number of readmissions and emergency department visits measured in number of patients who were readmitted or visited the emergency department during first 90 days after surgery.

• Length of stay

  Measured in number of days patient stayed in the hospital following total hip arthroplasty. This will be one measurement for each participant in the study within 1 week after surgery.

• DVT

  Incidence of deep vein thrombosis measured in number of patients having this complication during first 90 days after surgery

Study Arms (3)

Group A

EXPERIMENTAL

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)

Drug: Tranexamic Acid

Group B

EXPERIMENTAL

Group B: Topical Tranexamic acid at a dose of 1 gram injected in to the periarticular tissues prior to closure and 1 gram injected into the joint through the drain following wound closure. (Total dose administered is 2 grams)

Drug: Tranexamic Acid

Group C

EXPERIMENTAL

Group C: Combined Intravenous 1 gram given intravenous 30 min prior to skin incision and topical tranexamic acid (1 gram) injected in to the periarticular tissues prior to closure. (Total dose administered is 2 grams)

Drug: Tranexamic Acid

Interventions

Tranexamic Acid DRUG

intravenous versus Intraarticular versus intravenous

Group A; Group B; Group C

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be eligible to participate in the study, subjects must meet the following criteria:
• Males or females age \> 18 years and \<80 years
• Informed consent
• Diagnosis of primary osteoarthritis or osteonecrosis

You may not qualify if:

• Subjects who meet any of the following criteria will NOT be eligible to participate in the study:
• 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.
• Has an active joint infection\\
• 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
• Chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
• Body mass index \> 45
• Life expectancy \< 6 months
• Renal insufficiency (serum creatinine \>2.5 mg/dl)
• Pre-operative Hemoglobin \<8 gm/dl
• Congenital and acquired coagulopathy
• Patients on pre-operative therapeutic anticoagulation
• Patients who need post-operative therapeutic anticoagulation
• Pregnancy and nursing mothers or women who are expected to nurse their babies within one month of surgery
• History of thromboembolism, stroke, transient ischemic attack, traumatic brain injury, subdural, or subarachnoid hemorrhage
• History of reported allergy to tranexamic acid

Sponsors & Collaborators

• Albany Medical College: lead

Study Sites (1)

Albany Medical Center

Albany, New York, 12208, United States

RECRUITING

Related Publications (23)

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• Moskal JT, Capps SG. Meta-analysis of Intravenous Tranexamic Acid in Primary Total Hip Arthroplasty. Orthopedics. 2016 Sep 1;39(5):e883-92. doi: 10.3928/01477447-20160526-02. Epub 2016 Jun 1.

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• Madsen RV, Nielsen CS, Kallemose T, Husted H, Troelsen A. Low Risk of Thromboembolic Events After Routine Administration of Tranexamic Acid in Hip and Knee Arthroplasty. J Arthroplasty. 2017 Apr;32(4):1298-1303. doi: 10.1016/j.arth.2016.10.015. Epub 2016 Oct 20.

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• Hanna SA, Prasad A, Lee J, Achan P. Topical Versus Intravenous Administration of Tranexamic Acid in Primary Total Hip Arthroplasty: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Orthop Rev (Pavia). 2016 Sep 19;8(3):6792. doi: 10.4081/or.2016.6792. eCollection 2016 Sep 19.

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• Babis GC. Controversy in Tranexamic Acid Administration Route Continues: Commentary on an article by Zeng Yi, MD, et al.: "Tranexamic Acid Administration in Primary Total Hip Arthroplasty: A Randomized Controlled Trial of Intravenous Combined with Topical Versus Single-Dose Intravenous Administration". J Bone Joint Surg Am. 2016 Jun 15;98(12):e51. doi: 10.2106/JBJS.16.00128. No abstract available.

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• North WT, Mehran N, Davis JJ, Silverton CD, Weir RM, Laker MW. Topical vs Intravenous Tranexamic Acid in Primary Total Hip Arthroplasty: A Double-Blind, Randomized Controlled Trial. J Arthroplasty. 2016 May;31(5):1022-6. doi: 10.1016/j.arth.2015.11.003. Epub 2015 Nov 10.

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MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Ravneet S Bhullar, MD

  Albany Medcial Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samik Banerjee, MBBS

CONTACT

908-376-8990; banerjs1@mail.amc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Division of Orthopaedic Surgery

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: December 2, 2017
• Study Start: July 1, 2017
• Primary Completion: June 30, 2019
• Study Completion: December 31, 2019
• Last Updated: December 2, 2017

Record last verified: 2017-11

Locations

US (1)