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NCT Number: NCT04089865

Oral Versus Intravenous 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).

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Key information

Conditions

Blood Loss Blood Transfusion Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital for Special Surgery

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic Acid

Drug

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

Primary outcomes

  1. Calculated Blood Loss

    Time frame: post-operative day 0

    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.

Secondary outcomes

  1. Transfusion During Hospital Stay

    Time frame: From Post-Operative Day 0 to Post-Operative Day 2

    To assess how many participants required a blood transfusion during their hospital stay. This will be measured in binary responses (yes/no).

  2. Time to Discharge From Physical Therapy

    Time frame: From 48-72 hours after surgery

    Time to discharge from physical therapy (in minutes)

  3. Length of Stay

    Time frame: After surgery to the time discharged from hospital (estimated 48-72 hours after surgery)

    Hospital length of stay (in minutes)

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

Blood Loss in Arthroplasty With Oral Versus IV Tranexamic Acid

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 13, 2019
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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