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Trial record 83 of 419 for:    TRANEXAMIC ACID

The Use of Tranexamic Acid to Reduce Perioperative Blood Loss During High Risk Spine Fusion Surgery (TXA)

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ClinicalTrials.gov Identifier: NCT01728636
Recruitment Status : Completed
First Posted : November 20, 2012
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Louanne Carabini, Northwestern University

Brief Summary:
The purpose of this study is to determine if tranexamic acid reduces perioperative blood loss and red blood cell transfusion during high risk spine surgery.

Condition or disease Intervention/treatment Phase
Curvature of Spine Drug: Tranexamic Acid Phase 2

Detailed Description:
There are conflicting studies in the literature reporting different efficacy outcomes for the use of antifibrinolytics in spine fusion surgery. Several studies support the successful use of tranexamic acid for major orthopedic procedures, but the patient populations studied for spine surgery thus far have been small and highly variable, with less than clinically significant results. If TXA if efficacious in reducing not only perioperative blood loss, but RBC transfusion without an increase in thromboembolic events, then its use may be justified for patients at risk for major blood transfusion.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of Tranexamic Acid to Reduce Perioperative Blood Loss During High Risk Spine Fusion Surgery
Study Start Date : January 15, 2013
Actual Primary Completion Date : December 30, 2017
Actual Study Completion Date : December 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Tranexamic Acid
Tranexamic acid 10mg/kg loading dose given pre-incision and 1mg/kg/hr infusion throughout intraoperative period
Drug: Tranexamic Acid
intravenous administration of bolus and infusion for duration of surgical procedure
Other Name: Lysteda

Placebo Comparator: Placebo
Normal saline placebo loading dose 0.5ml/kg and infusion at 0.5ml/kg/hr throughout operative course
Drug: Tranexamic Acid
intravenous administration of bolus and infusion for duration of surgical procedure
Other Name: Lysteda




Primary Outcome Measures :
  1. Total Red Blood Cells Transfused in the Perioperative Period [ Time Frame: 24 hours after skin incision ]
    Total Red Blood Cells Transfused in the Perioperative Period in units.


Secondary Outcome Measures :
  1. Additional blood product transfused (Fresh frozen plasma, Cryoprecipitate, and Platelets) [ Time Frame: 24 hours after skin incision ]
    Total additional blood products transfused in the perioperative period measured in units


Other Outcome Measures:
  1. Adjunctive procoagulant medications [ Time Frame: 24 hours after skin incision ]
    DDAVP and rFVIIa administration

  2. Estimated Intraoperative Blood Loss [ Time Frame: 24 hours after skin incision ]
    Estimated Intraoperative blood loss in milliliters (mLs)

  3. Postoperative Blood loss [ Time Frame: 24 hours after skin incision ]
    Estimated postoperative blood loss in milliliters (mLs)

  4. Intravenous Fluid Administration [ Time Frame: 24 hours after skin incision ]
    Intravenous fluid administration in milliliters (mLs)

  5. Incidence thromboembolism prior to discharge [ Time Frame: 120 hours after skin incision ]
    Incidence of cerebral, cardiac, or renal thromboembolism prior to discharge as demonstrated by scan (ultrasound,MRI, CT scan, X-ray)

  6. Incidence of venous thromboembolism [ Time Frame: 120 hours after skin incision ]
    As demonstrated by ultrasound or x-ray device



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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:

  • age>17 years
  • undergoing posterior spine fusion surgery for kyphoscoliosis with a >80% chance of major transfusion

Exclusion Criteria:

  • age < 18 years
  • non-English speaking
  • pregnancy
  • emergency procedures
  • surgery for tumor, trauma or infection
  • severe coronary artery disease
  • history of venous thromboembolism
  • history of cerebral vascular accident
  • history of renal insufficiency
  • allergy to tranexamic acid

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): NCT01728636


Locations
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United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Louanne M Carabini, MD Northwestern University Feinberg School of Medicine

Publications:

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Responsible Party: Louanne Carabini, Assistant Professor of Anesthesiology & Neurological Surgery, Northwestern University
ClinicalTrials.gov Identifier: NCT01728636     History of Changes
Other Study ID Numbers: STU00066949
First Posted: November 20, 2012    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants