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Trial record 90 of 420 for:    TRANEXAMIC ACID

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
Sponsor:
Information provided by (Responsible Party):
Kenneth Bauer, The New England Baptist Hospital

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Blood Loss, Surgical Blood Loss, Postoperative Drug: Tranexamic Acid (Oral) Drug: Tranexamic Acid (Intravenous) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
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.
Other Names:
  • trans-4-(aminomethyl)cyclohexanecarboxylic acid
  • Lysteda

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.
Other Names:
  • trans-4-(aminomethyl)cyclohexanecarboxylic acid
  • Cyklokapron




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Lower incidences of patients requiring blood transfusion. [ Time Frame: 2 Years ]
    Lower incidences of patients requiring blood transfusion in the OR, or post-operatively.

  2. 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.

  3. Length of Stay [ Time Frame: 1-3 Days ]
    Potential for a shorter length of hospital stay for post-surgical patients.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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United States, Massachusetts
New England Baptist Hospital
Boston, Massachusetts, United States, 02120
Sponsors and Collaborators
The New England Baptist Hospital
Investigators
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Principal Investigator: Kenneth Bauer, MD New England Baptist Hospital

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Responsible Party: Kenneth Bauer, Principal Investigator, The New England Baptist Hospital
ClinicalTrials.gov Identifier: NCT02438566     History of Changes
Other Study ID Numbers: 654455
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: March 22, 2016
Last Verified: March 2016
Keywords provided by Kenneth Bauer, The New England Baptist Hospital:
Tranexamic Acid
Blood Loss
Total Hip Replacement
Bilateral Knee Replacement
Additional relevant MeSH terms:
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Tranexamic Acid
Hemorrhage
Blood Loss, Surgical
Postoperative Hemorrhage
Pathologic Processes
Intraoperative Complications
Postoperative Complications
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants