Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
101 participants
INTERVENTIONAL
2012-05-31
2018-12-31
Brief Summary
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The hypothesis of this study is that tranexamic acid will be associated with a decrease in post-operative blood loss, as well as a decreased need for allogenic blood transfusion, in patients who have fracture surgery around the hip and knee.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Control
No tranexamic acid given
No interventions assigned to this group
Tranexamic Acid
15 mg/kg preoperative IV dose followed by another 15 mg/kg IV dose three hours after the initial dose
Tranexamic Acid
Interventions
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Tranexamic Acid
Eligibility Criteria
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Inclusion Criteria
* Expected blood loss is greater than 300 mL
* Age ≥ 18
* Skeletal maturity
Exclusion Criteria
* Patients taking oral contraceptives
* Contraindication to venous thromboembolic event (VTE) prophylaxis (intracranial, intrathoracic, intra-abdominal bleeding or spine fractures)
* Patients requiring operative intervention for other injuries (orthopaedic or non-orthopaedic)
* Known hypercoagulable state including history of prescribed anti-coagulation (warfarin, plavix, low molecular weight heparin)
* Renal Insufficiency (creatinine greater than 1.5mg/dL)
* Open fractures
18 Years
ALL
No
Sponsors
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University of Tennessee
OTHER
Responsible Party
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Principal Investigators
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Dirk W Kiner, MD
Role: PRINCIPAL_INVESTIGATOR
UTCOM Chattanooga / Erlanger Health System
Locations
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Erlanger Health System
Chattanooga, Tennessee, United States
Countries
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Other Identifiers
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11-036
Identifier Type: -
Identifier Source: org_study_id
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