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

• Status: Unknown status
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The New England Baptist Hospital
• Treatments: Tranexamic Acid

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.