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Trial record 93 of 420 for:    TRANEXAMIC ACID

Tranexamic Acid in Orthopaedic Trauma Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02080494
Recruitment Status : Active, not recruiting
First Posted : March 6, 2014
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
University of Tennessee

Brief Summary:

Tranexamic acid is an antifibrinolytic drug that has been used to decrease post-operative blood loss. This study is a prospective, randomized controlled trial investigating the use of tranexamic acid in fracture surgery around the hip and knee, in which significant blood loss (>300mL) is expected.

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.


Condition or disease Intervention/treatment Phase
Blood Loss Trauma Fracture Surgery Drug: Tranexamic Acid Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Tranexamic Acid in Orthopaedic Trauma Surgery
Study Start Date : May 2012
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
No tranexamic acid given
Experimental: Tranexamic Acid
15 mg/kg preoperative IV dose followed by another 15 mg/kg IV dose three hours after the initial dose
Drug: Tranexamic Acid



Primary Outcome Measures :
  1. hemoglobin value [ Time Frame: through postoperative day four ]

Secondary Outcome Measures :
  1. hematocrit value [ Time Frame: through postoperative day four ]
  2. number of units of allogenic blood transfused [ Time Frame: through postoperative day four ]


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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:

  • Patients with isolated fractures of the pelvic ring, acetabulum, femur or tibia that will require open reduction and internal fixation
  • Expected blood loss is greater than 300 mL
  • Age ≥ 18
  • Skeletal maturity

Exclusion Criteria:

  • Pregnant or breastfeeding
  • 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

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): NCT02080494


Locations
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United States, Tennessee
Erlanger Health System
Chattanooga, Tennessee, United States, 37403
Sponsors and Collaborators
University of Tennessee
Investigators
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Principal Investigator: Dirk W Kiner, MD UTCOM Chattanooga / Erlanger Health System

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Responsible Party: University of Tennessee
ClinicalTrials.gov Identifier: NCT02080494     History of Changes
Other Study ID Numbers: 11-036
First Posted: March 6, 2014    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Tennessee:
tranexamic acid
orthopaedic trauma
pelvic fracture
hip fracture
femur fracture
blood loss
Additional relevant MeSH terms:
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Hemorrhage
Wounds and Injuries
Pathologic Processes
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants