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

NCT ID: NCT02438566

Last Updated: 2016-03-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2017-04-30

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.

Conditions

Osteoarthritis; Blood Loss, Surgical; Blood Loss, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Tranexamic Acid (Oral)

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

Tranexamic Acid (Intravenous)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

trans-4-(aminomethyl)cyclohexanecarboxylic acid; Lysteda; trans-4-(aminomethyl)cyclohexanecarboxylic acid; Cyklokapron

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The New England Baptist Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kenneth Bauer

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kenneth Bauer, MD

Role: PRINCIPAL_INVESTIGATOR

New England Baptist Hospital

Locations

New England Baptist Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

654455

Identifier Type: -

Identifier Source: org_study_id