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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

Tracking Information
First Submitted Date  ICMJE January 28, 2014
First Posted Date  ICMJE February 3, 2014
Last Update Posted Date January 21, 2020
Study Start Date  ICMJE March 2014
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2014)
  • 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.
  • Complications [ Time Frame: 90 days ]
    To compare the rates of intraoperative complications and 90 day complications observed in the two groups.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tranexamic Acid Dosing in Adult Spinal Deformity Surgery
Official Title  ICMJE Low Versus High Dose Tranexamic Acid in Adult Spinal Deformity Surgery: A Randomized, Blinded, Controlled Trial
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Adult Spinal Deformity
Intervention  ICMJE Drug: Tranexamic Acid (Cyklokapron)
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: Drug: Tranexamic Acid (Cyklokapron)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 30, 2014)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michael P Kelly, MD, MSCI(p) 314-747-2535 kellymi@wudosis.wustl.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02053363
Other Study ID Numbers  ICMJE 201312010
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Kelly, Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE AOSpine North America
Investigators  ICMJE
Principal Investigator: Michael P. Kelly, MD, MSCI(p) Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP