Oral Versus Intravenous Tranexamic Acid

Blood Loss in Arthroplasty With Oral Versus IV Tranexamic Acid

The goal of this randomized clinical control trial is to determine whether oral TXA dosing in THA/TKA result in more blood loss and more transfusions compared to IV TXA dosing in patients undergoing THA/TKA under neuraxial anesthesia. The main questions it aims to answer are:

Does oral TXA dosing in THA/TKA result in more blood loss compared to IV TXA dosing?

Does oral TXA dosing in THA/TKA result in more transfusions compared to IV TXA dosing?

Participants will be randomly assigned to either get the Oral TXA (1950mg) or the IV TXA (1g) on their day of surgery. Researchers will compare these groups to see if any differences emerged. 200 THA patients (100 Oral, 100 IV), 200 TKA patients (100 oral, 100 IV).

Study Overview

• Status: Completed
• Conditions: Blood Loss; Blood Transfusion
• Intervention / Treatment: Drug: Tranexamic Acid

Detailed Description

Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. The use of TXA in total hip arthroplasty (THA) and total knee arthroplasty (TKA) has resulted in dramatic decreases in operative blood loss and transfusion rates, revolutionizing the field of arthroplasty. The use of TXA, now common, has made autologous blood donation programs largely obsolete. Additionally, it has made perioperative blood transfusion uncommon.

While AAOS guidelines suggest that all three available preparations of TXA (oral, IV, topical) are effective, preferred route of dosing varies by provider and institution. These preferences are based on habit, understanding of pharmacodynamics, and logistical issues regarding effective dosing. Oral TXA is the cheapest option, but some surgeons prefer IV dosing due to concerns regarding efficacy and controlled dosing.

In this study, we seek to compare the efficacy of a single pre-op oral dose of TXA to a single pre-op IV dose of TXA.

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients undergoing total hip arthroplasty (THA) through a posterior approach
• Patients undergoing total knee arthroplasty (TKA)
• Patients between 18-80 years of age

Exclusion Criteria:

• Patients with >80 years of age
• Patients with a BMI over 40
• Patients undergoing general anesthesia
• Patients with a history of major ipsilateral joint surgery
• Patients on pre-operative anticoagulation or anti-platelet drugs (other than aspirin)
• Patients with a history of bleeding disorders
• Patients with platelets less than 100/nl
• Patients with new-onset/active atrial fibrillation
• Patients with a history of myocardial infarction in the past year
• Patients with a history of a stroke in the past year

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral Tranexamic Acid (TXA); 100 Total Hip Arthroplasty (THA) and 100 Total Knee Arthroplasty (TKA) patients will be randomized to receive 1950 mg of oral TXA in the pre-operative area.	Drug: Tranexamic Acid; Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.; Other Names: Lysteda
Active Comparator: Intravenous (IV) Tranexamic Acid (TXA); 100 Total Hip Arthroplasty (THA) and 100 Total Knee Arthroplasty (TKA) patients will be randomized to receive 1 g of intravenous (IV) TXA upon transfer to the operating room.	Drug: Tranexamic Acid; Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.; Other Names: Lysteda

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calculated Blood Loss	Calculated Blood loss (CBL) measured in mL, measured at baseline (before surgery) and in the post-operative care unit (after surgery). The following formula was used CBL = BV × (HctPre - HctPost), where BV = (k1 × H3) + (k2 × W) + k3. The variables for the formula are as followed: CBL: Calculated blood loss BV: Blood volume at baseline HctPre: Haematocrit before surgery HctPost: Haematocrit after surgery H: Patient height in meters W: Patient weight in kilograms Although measured at two time points (before and after surgery), the calculated value from those two time points is average across all participants and reported.	post-operative day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transfusion During Hospital Stay	To assess how many participants required a blood transfusion during their hospital stay. This will be measured in binary responses (yes/no).	From Post-Operative Day 0 to Post-Operative Day 2
Time to Discharge From Physical Therapy	Time to discharge from physical therapy (in minutes)	From 48-72 hours after surgery
Length of Stay	Hospital length of stay (in minutes)	After surgery to the time discharged from hospital (estimated 48-72 hours after surgery)

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York
• Investigators: Principal Investigator: Stavros Memtsoudis, MD PhD, Hospital for Special Surgery, New York

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2019
• Primary Completion (Actual): November 10, 2021
• Study Completion (Actual): November 10, 2021

Study Registration Dates

• First Submitted: September 6, 2019
• First Submitted That Met QC Criteria: September 12, 2019
• First Posted (Actual): September 13, 2019

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 2019-0882

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Certain individual participant data will be available. Individual participant data that underlie the results reported in a future article, after deidentification (text, tables, figures, appendices).
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal, in order to achieve aims in the approved proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No