Back to resultsNon-inferiority Trial of Oral Tranexamic Acid vs. Intravenous Tranexamic Acid in Joint Replacement Surgery
Primary Purpose
Osteoarthritis, Blood Loss, Surgical, Blood Loss, Postoperative
Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tranexamic Acid (Oral)
Tranexamic Acid (Intravenous)
Sponsored by
About this trial
This is an interventional prevention trial for Osteoarthritis focused on measuring Tranexamic Acid, Blood Loss, Total Hip Replacement, Bilateral Knee Replacement
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.
Sites / Locations
- New England Baptist Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Oral Tranexamic Acid (OTA)
Intravenous Tranexamic Acid (IVTA)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Lower incidences of patients requiring blood transfusion.
Lower incidences of patients requiring blood transfusion in the OR, or post-operatively.
Lower Blood Loss in Patients
Lower amounts of blood loss in patients during in surgery, and post-operatively.
Length of Stay
Potential for a shorter length of hospital stay for post-surgical patients.
Full Information
NCT ID
NCT02438566
First Posted
April 14, 2015
Last Updated
March 21, 2016
Sponsor
The New England Baptist Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02438566
Brief Title
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
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
April 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The New England Baptist Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Blood Loss, Surgical, Blood Loss, Postoperative
Keywords
Tranexamic Acid, Blood Loss, Total Hip Replacement, Bilateral Knee Replacement
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
118 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oral Tranexamic Acid (OTA)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intravenous Tranexamic Acid (IVTA)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid (Oral)
Other Intervention Name(s)
trans-4-(aminomethyl)cyclohexanecarboxylic acid, Lysteda
Intervention Description
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
Intervention Name(s)
Tranexamic Acid (Intravenous)
Other Intervention Name(s)
trans-4-(aminomethyl)cyclohexanecarboxylic acid, Cyklokapron
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lower number of units of blood required for transfusion.
Description
Lower number of units of blood required for transfusion in the OR and post-operatively, hospital-wide.
Time Frame
2 Years
Secondary Outcome Measure Information:
Title
Lower incidences of patients requiring blood transfusion.
Description
Lower incidences of patients requiring blood transfusion in the OR, or post-operatively.
Time Frame
2 Years
Title
Lower Blood Loss in Patients
Description
Lower amounts of blood loss in patients during in surgery, and post-operatively.
Time Frame
Hospital Stay: 1-3 days.
Title
Length of Stay
Description
Potential for a shorter length of hospital stay for post-surgical patients.
Time Frame
1-3 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Bauer, MD
Organizational Affiliation
New England Baptist Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
New England Baptist Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02120
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Non-inferiority Trial of Oral Tranexamic Acid vs. Intravenous Tranexamic Acid in Joint Replacement Surgery
We'll reach out to this number within 24 hrs