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

Osteoarthritis Clinical Trial

Official title:

Non-inferiority Trial of Oral Tranexamic Acid (OTA) vs. Intravenous Tranexamic Acid (IVTA) to Prevent Blood Loss in Joint Replacement Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02438566
• Other study ID #: 654455
• Status: Active, not recruiting
• Phase: Phase 3
• First received: April 14, 2015
• Last updated: March 21, 2016
• Start date: April 2015
• Est. completion date: April 2017

Study information

• Verified date: March 2016
• Source: The New England Baptist Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 118
• Est. completion date: April 2017
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Blood Loss, Postoperative
• Blood Loss, Surgical
• Hemorrhage
• Osteoarthritis
• Postoperative Hemorrhage

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
United States	New England Baptist Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
The New England Baptist Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower number of units of blood required for transfusion.	Lower number of units of blood required for transfusion in the OR and post-operatively, hospital-wide.	2 Years	No
Secondary	Lower incidences of patients requiring blood transfusion.	Lower incidences of patients requiring blood transfusion in the OR, or post-operatively.	2 Years	No
Secondary	Lower Blood Loss in Patients	Lower amounts of blood loss in patients during in surgery, and post-operatively.	Hospital Stay: 1-3 days.	No
Secondary	Length of Stay	Potential for a shorter length of hospital stay for post-surgical patients.	1-3 Days	No