Non-inferiority Trial of Oral Tranexamic Acid vs. Intravenous Tranexamic Acid in Joint Replacement Surgery

Non-inferiority Trial of Oral Tranexamic Acid (OTA) vs. Intravenous Tranexamic Acid (IVTA) to Prevent Blood Loss in Joint Replacement Surgery

The purpose of this research is to determine if the oral form of a medication (tranexamic acid) to reduce bleeding can be used in place of an intravenous (IV) form, to learn the best way to give tranexamic acid: either a pill by mouth, or a solution by vein.

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis; Blood Loss, Surgical; Blood Loss, Postoperative
• Intervention / Treatment: Drug: Tranexamic Acid (Oral); Drug: Tranexamic Acid (Intravenous)

Detailed Description

The purpose of this research is to determine if the oral form of a medication (tranexamic acid) to reduce bleeding can be used in place of an intravenous (IV) form.to learn the best way to give tranexamic acid: either a pill by mouth, or a solution by vein. Tranexamic acid is a medicine that reduces blood loss and reduces the need for blood transfusions in surgery. This drug is not experimental and has been used widely to treat patients in many settings, including orthopedic procedures, to reduce bleeding. This medication is now part of the standard of care at many centers in the U.S. and around the world. Orthopedic procedures have used iv tranexamic acid more often, but there are reasons to believe that the oral form may be at least equivalent and perhaps better at lower cost to the health care system. No other study has yet performed a systematic comparison to answer the question.

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02120
      • New England Baptist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• To be included into this study, you must be undergoing hip or bilateral knee replacement surgery.
• You must be healthy enough to undergo joint replacement surgery.
• You must be able to understand and sign an informed consent.
• You must be at least 18 years of age.

Exclusion Criteria:

• You cannot be under 18 years of age.
• You cannot be undergoing revision hip or revision bilateral knee replacement surgery.
• You cannot be part of this study if you are allergic to the medication
• You cannot participate if you are on hemodialysis,
• You cannot participate if you have active coronary artery disease and if you have various vascular stents in place.
• You will also be excluded if you have ever had a blood clot (deep vein thrombosis (DVT), pulmonary embolism (PE)).
• You will also be excluded if you have ever had a cerebral or subarachnoid hemorrhage (brain bleeding), or stroke (cerebral vascular accident or transient ischemic attack).
• If you are on estrogen-containing medication (hormone replacement therapy or oral contraceptive) within 7 days of surgery, you cannot take part in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Oral Tranexamic Acid (OTA); Subjects will be randomized 1:1 to receive either IVTA or OTA with corresponding placebos. OTA will be given as 1950 mg 1-2 hours prior to OR and 1950 mg 2 hours after surgical close, before discharge from PACU.	Drug: Tranexamic Acid (Oral); OTA will be given as 1950 mg 1-2 hours prior to OR and 1950 mg 2 hours after surgical close, before discharge from PACU.; Other Names: Lysteda; trans-4-(aminomethyl)cyclohexanecarboxylic acid
Active Comparator: Intravenous Tranexamic Acid (IVTA); Subjects will be randomized 1:1 to receive either IVTA or OTA with corresponding placebos. IVTA will be given as 1 g intravenously at time of first incision (THA or bTKA without tourniquet) or just before 1st tourniquet application (bTKA), and then again, 1 g after final surgery closure.	Drug: Tranexamic Acid (Intravenous); IVTA will be given as 1 g intravenously at time of first incision (THA or bTKA without tourniquet) or just before 1st tourniquet application (bTKA), and then again, 1 g after final surgery closure.; Other Names: Cyklokapron; trans-4-(aminomethyl)cyclohexanecarboxylic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lower number of units of blood required for transfusion.	Lower number of units of blood required for transfusion in the OR and post-operatively, hospital-wide.	2 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lower incidences of patients requiring blood transfusion.	Lower incidences of patients requiring blood transfusion in the OR, or post-operatively.	2 Years
Lower Blood Loss in Patients	Lower amounts of blood loss in patients during in surgery, and post-operatively.	Hospital Stay: 1-3 days.
Length of Stay	Potential for a shorter length of hospital stay for post-surgical patients.	1-3 Days

Collaborators and Investigators

• Sponsor: The New England Baptist Hospital
• Investigators: Principal Investigator: Kenneth Bauer, MD, New England Baptist Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): April 1, 2016
• Study Completion (Anticipated): April 1, 2017

Study Registration Dates

• First Submitted: April 14, 2015
• First Submitted That Met QC Criteria: May 5, 2015
• First Posted (Estimate): May 8, 2015

Study Record Updates

• Last Update Posted (Estimate): March 22, 2016
• Last Update Submitted That Met QC Criteria: March 21, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Blood Loss; Tranexamic Acid; Total Hip Replacement; Bilateral Knee Replacement
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Intraoperative Complications; Hemorrhage; Blood Loss, Surgical; Postoperative Hemorrhage; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 654455