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Trial record 10 of 11 for:    aospine

Tranexamic Acid Dosing in Adult Spinal Deformity 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02053363
Recruitment Status : Recruiting
First Posted : February 3, 2014
Last Update Posted : January 21, 2020
Sponsor:
Collaborator:
AOSpine North America
Information provided by (Responsible Party):
Michael Kelly, Washington University School of Medicine

Brief Summary:
The purpose of this study is to evaluate two dosing protocols for tranexamic acid (TXA), an anti-fibrinolytic used to decrease blood loss in adult patients undergoing complex, reconstructive spinal fusion surgeries.

Condition or disease Intervention/treatment Phase
Adult Spinal Deformity Drug: Tranexamic Acid (Cyklokapron) Phase 2 Phase 3

Detailed Description:

After consent is obtained and the patient is enrolled in the trial, patients will be assigned de-identified, unique identification (ID) numbers. Randomization of these IDs to either low or high dose TXA will occur via a computer generated random assignment. Given the variations that may exist in surgical technique (e.g. performance of osteotomies), stratified randomization will be performed by attending surgeon. Based upon the randomization, the pharmacy will prepare TXA for one of two intravenous dosing protocols:

  1. Low Dose (Standard of Care/Control): Loading Dose 10mg/kg given over 15 minutes, followed by 1mg/kg/hr via continuous infusion
  2. High Dose (Study Group): Loading Dose 50mg/kg given over 15 minutes, followed by 5mg/kg/hr via continuous infusion.

The surgeon, anesthesia team, and operating room staff will be blind to the concentration of TXA in the medications received. Treatments may be "unblinded" at the discretion of the surgeon and anesthesiologist, in cases of extreme blood loss. If additional anti-fibrinolytics are given, the change in dose will be recorded.

Post-operative care will be the same as any other patient and data collection will be information contained in the patient's medical record that is part of routine, standard of care.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Low Versus High Dose Tranexamic Acid in Adult Spinal Deformity Surgery: A Randomized, Blinded, Controlled Trial
Study Start Date : March 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High Dose/Study Group
Tranexamic Acid (Cyklokapron) Loading Dose 50mg/kg given over 15 minutes, followed by 5mg/kg/hr via continuous infusion. The loading dose will be given to coincide with incision. The continuous infusion will be stopped at the conclusion of fascial layer closure.
Drug: Tranexamic Acid (Cyklokapron)
Active Comparator: Standard of Care/Control
Tranexamic Acid (Cyklokapron) Loading Dose 10mg/kg given over 15 minutes, followed by 1mg/kg/hr via continuous infusion. The loading dose will be given to coincide with incision. The continuous infusion will be stopped at the conclusion of fascial layer closure.
Drug: Tranexamic Acid (Cyklokapron)



Primary Outcome Measures :
  1. Blood Loss [ Time Frame: Participants will be followed for the duration of their hospital stay, an expected average of 1 week. ]
    To compare the estimated blood loss in patients undergoing complex, reconstructive, spinal fusion surgeries receiving one of two dosing protocols for the anti-fibrinolytic, TXA.


Secondary Outcome Measures :
  1. Red Blood Cell Transfusions [ Time Frame: Participants will be followed for the duration of their hospital stay, an expected average of 1 week. ]
    To compare the mean number of packed red blood cell (PRBC) transfusions given to the two groups.

  2. Complications [ Time Frame: 90 days ]
    To compare the rates of intraoperative complications and 90 day complications observed in the two groups.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients (ages 18-75) scheduled to undergo long segment (greater than 8 motion segments) posterior spinal fusion with instrumentation (PSF) for adult scoliosis

Exclusion Criteria:

  • Patients with acquired defective color vision
  • Subarachnoid hemorrhage
  • Active intravascular clotting
  • Hypersensitivity to tranexamic acid or any of the ingredients
  • Patients who pre-donate autologous blood for intra- or post-operative use (Directed donor units are acceptable)
  • History of suspected blood disorders or abnormal coagulation laboratory results
  • Current anticoagulation therapy that cannot be interrupted
  • History of deep vein thrombosis (DVT)
  • Impaired renal function or creatinine clearance <60 ml/min
  • Pregnancy or women who are lactating/breastfeeding
  • Women on hormonal contraceptives

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): NCT02053363


Contacts
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Contact: Michael P Kelly, MD, MSCI(p) 314-747-2535 kellymi@wudosis.wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Elfaridah P. Frazier, PhD    314-747-2574    fraziera@wudosis.wustl.edu   
Principal Investigator: Michael P. Kelly, MD, MSCI(p)         
Sub-Investigator: Lawrence Lenke, MD         
Sub-Investigator: Keith Bridwell, MD         
Sponsors and Collaborators
Washington University School of Medicine
AOSpine North America
Investigators
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Principal Investigator: Michael P. Kelly, MD, MSCI(p) Washington University School of Medicine
Publications:

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Responsible Party: Michael Kelly, Assistant Professor, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02053363    
Other Study ID Numbers: 201312010
First Posted: February 3, 2014    Key Record Dates
Last Update Posted: January 21, 2020
Last Verified: January 2020
Keywords provided by Michael Kelly, Washington University School of Medicine:
tranexamic acid, reconstructive spine surgery
Additional relevant MeSH terms:
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Congenital Abnormalities
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants