Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-29 @ 9:47 PM
Study NCT ID:
NCT02438566
Status:
UNKNOWN
Last Update Posted:
2016-03-22
First Post:
2015-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-inferiority Trial of Oral Tranexamic Acid vs. Intravenous Tranexamic Acid in Joint Replacement Surgery
Sponsor:
The New England Baptist Hospital
Organization:
Study Overview
Official Title:
Non-inferiority Trial of Oral Tranexamic Acid (OTA) vs. Intravenous Tranexamic Acid (IVTA) to Prevent Blood Loss in Joint Replacement Surgery
Status:
UNKNOWN
Status Verified Date:
2016-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: