Non-inferiority Trial of Oral Tranexamic Acid vs. Intravenous Tranexamic Acid in Joint Replacement Surgery
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|ClinicalTrials.gov Identifier: NCT02438566|
Recruitment Status : Unknown
Verified March 2016 by Kenneth Bauer, The New England Baptist Hospital.
Recruitment status was: Active, not recruiting
First Posted : May 8, 2015
Last Update Posted : March 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis Blood Loss, Surgical Blood Loss, Postoperative||Drug: Tranexamic Acid (Oral) Drug: Tranexamic Acid (Intravenous)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||118 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Non-inferiority Trial of Oral Tranexamic Acid (OTA) vs. Intravenous Tranexamic Acid (IVTA) to Prevent Blood Loss in Joint Replacement Surgery|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||April 2016|
|Estimated Study Completion Date :||April 2017|
Active Comparator: 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.
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.
Active Comparator: 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.
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.
- Lower number of units of blood required for transfusion. [ Time Frame: 2 Years ]Lower number of units of blood required for transfusion in the OR and post-operatively, hospital-wide.
- Lower incidences of patients requiring blood transfusion. [ Time Frame: 2 Years ]Lower incidences of patients requiring blood transfusion in the OR, or post-operatively.
- Lower Blood Loss in Patients [ Time Frame: Hospital Stay: 1-3 days. ]Lower amounts of blood loss in patients during in surgery, and post-operatively.
- Length of Stay [ Time Frame: 1-3 Days ]Potential for a shorter length of hospital stay for post-surgical patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02438566
|United States, Massachusetts|
|New England Baptist Hospital|
|Boston, Massachusetts, United States, 02120|
|Principal Investigator:||Kenneth Bauer, MD||New England Baptist Hospital|