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

Phase 3

• Conditions: Osteoarthritis; Blood Loss, Surgical; Blood Loss, Postoperative
• Interventions: Drug: Tranexamic Acid (Intravenous); Drug: Tranexamic Acid (Oral)

• Registration Number: NCT02438566
• Lead Sponsor: The New England Baptist Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-14
• Study First Submitted QC: 2015-05-05
• Study First Posted: 2015-05-08
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-21
• Last Update Posted: 2016-03-22
• Primary Completion: 2016-04
• Study Completion: 2017-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 118

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous Tranexamic Acid (IVTA)	Tranexamic Acid (Intravenous)	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.
Oral Tranexamic Acid (OTA)	Tranexamic Acid (Oral)	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.

Primary Outcome Measures

Name	Time	Method
Lower number of units of blood required for transfusion.	2 Years	Lower number of units of blood required for transfusion in the OR and post-operatively, hospital-wide.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

New England Baptist Hospital; 🇺🇸 Boston, Massachusetts, United States