Clinical trial NCT02438566: Non-inferiority Trial of Oral Tranexamic Acid vs. Intravenous Tranexamic Acid in Joint Replacement Surgery
Official title: Non-inferiority Trial of Oral Tranexamic Acid (OTA) vs. Intravenous Tranexamic Acid (IVTA) to Prevent Blood Loss in Joint Replacement Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Osteoarthritis
Blood Loss, Surgical
Blood Loss, Postoperative
Keywords: Tranexamic Acid
Blood Loss
Total Hip Replacement
Bilateral Knee Replacement
Lead sponsor: The New England Baptist Hospital
Sponsor class: OTHER
First posted: 2015-05-08
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Lower number of units of blood required for transfusion.
timeFrame: 2 Years
Secondary outcomes:
measure: Lower incidences of patients requiring blood transfusion.
timeFrame: 2 Years
measure: Lower Blood Loss in Patients
timeFrame: Hospital Stay: 1-3 days.
measure: Length of Stay
timeFrame: 1-3 Days
Other outcomes:
Locations:
city: Boston
country: United States
facility: New England Baptist Hospital
state: Massachusetts
Study officials:
affiliation: New England Baptist Hospital
name: Kenneth Bauer, MD
role: PRINCIPAL_INVESTIGATOR
References: