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Oral and Intravenous Tranexamic Acid in Lumbar Spine Surgery

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ClinicalTrials.gov Identifier: NCT03037515
Recruitment Status : Unknown
Verified January 2017 by Stephen Bartol, Henry Ford Health System.
Recruitment status was:  Not yet recruiting
First Posted : January 31, 2017
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
Stephen Bartol, Henry Ford Health System

Tracking Information
First Submitted Date  ICMJE January 23, 2017
First Posted Date  ICMJE January 31, 2017
Last Update Posted Date January 31, 2017
Estimated Study Start Date  ICMJE February 15, 2017
Estimated Primary Completion Date August 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2017)
Intra-operative blood loss between the two groups [ Time Frame: Day of surgery to 1 day after surgery, up to 7 days ]
For males: BV = 0.3669*(Height in meters)^3 + 0.03219*(Weight in kilograms) + 0.6041 For females: BV = 0.3561*(Height in meters)^3 + 0.03308*(Weight in kilograms) + 0.1833 Hbloss = BV*(Hbi-Hbe )*0.001 + Hbt Blood loss = 1000*(Hbloss/Hbi) Hbloss = Hemoglobin loss; BV = Blood Volume; Hbi = initial Hgb; Hbe = ending Hgb; Hbt = transfused Hgb = about 52g (SD 5.4g) per 1u pRBC (320mL)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2017)
  • Post-operative drop in hemoglobin between the two groups [ Time Frame: 1 day after surgery until patient is discharged, up to 7 days ]
  • Post-operative blood loss between the two groups [ Time Frame: 1 day after surgery until patient is discharged, up to 7 days ]
  • Number of units transfused between the two groups [ Time Frame: 1 day after surgery until patient is discharged, up to 7 days ]
  • Post-operative drain output between the two groups [ Time Frame: 1 day after surgery until patient is discharged, up to 7 days ]
  • Incidence of thromboembolic events between the two groups [ Time Frame: 1 day after surgery until patient returns for first postoperative visit (through study completion, an average of 4 weeks after surgery) ]
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 Oral and Intravenous Tranexamic Acid in Lumbar Spine Surgery
Official Title  ICMJE A Randomized Controlled Trial of Oral and Intravenous Tranexamic Acid in Lumbar Spine Surgery
Brief Summary The purpose of this project is to compare the effectiveness of two different but well accepted routes of administration of tranexamic acid in order to reduce blood loss and need for transfusion in patients undergoing lumbar spine surgery. Specifically, this study seeks to identify if intravenous tranexamic acid is superior to oral tranexamic acid in reducing blood loss and need for transfusion.
Detailed Description

Spine surgery is associated with large amount of perioperative blood loss. Factors influencing blood loss include surgical technique, operative time, number of vertebral levels arthrodesed, and others. Significant blood loss is associated with complications such as hypotension, end organ damage, or coagulopathy. Blood transfusions can increase risks of infection, blood incompatibility, and allergic reactions. Due to the significant risks and complications associated with blood loss and allogenic transfusions, efforts to identify safe and effective ways of lowering blood loss during spine surgery are crucial. Many methods have been utilized to reduce allogenic blood transfusions, such as autologous blood predonation, antifibrinolytic drugs, acute normovolemic hemodilution, intraoperative blood salvage, and others. Furthermore, the administration of antifibrinolytics, such as tranexamic acid (TXA) and epsilon-aminocaproic acid (EACA), has been shown to reduce bleeding in cardiac, gynecological, urologic and total joint replacement surgeries. There have been many published studies investigating various antifibrinolytic agents such as TXA, EACA, and aprotinin. While aprotinin was shown to increase mortality rate in patients following cardiac surgery, TXA and EACA have not been shown to cause any substantial morbidity or to increase rate of thromboembolic events. Although IV TXA has been shown to be effective in reducing blood loss and transfusions in patients undergoing spine surgery, no studies in the literature have investigated the efficacy of PO TXA in decreasing blood loss and transfusions. The investigators believe that PO TXA will be just as efficacious and more cost-effective in reducing blood loss and transfusion needs in patients undergoing lumbar spine surgery.

The ultimate goal is identifying the most cost-effective protocol to decrease blood loss and need for transfusion. If oral TXA is found to be as efficacious as IV TXA in reducing blood loss and need for transfusion, significant cost savings can be achieved for the patient and the health care system in general.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Blood Loss, Surgical
  • Blood Loss Anemia
Intervention  ICMJE Drug: Tranexamic Acid
To identify if intravenous tranexamic acid is superior to oral tranexamic acid in reducing blood loss and need for transfusion in lumbar spine surgery.
Other Name: Lysteda
Study Arms  ICMJE
  • Active Comparator: Intravenous Tranexamic Acid
    The IV TXA group will receive the standard dosing for our institution of 1 g TXA (diluted in 100 mL normal saline) given as an IV bolus immediately before incision and another 1 g TXA given before closure.
    Intervention: Drug: Tranexamic Acid
  • Active Comparator: Oral Tranexamic Acid
    The oral TXA group will receive 1950 mg TXA (3 tablets of 650 mg) approximately 2 hours before incision.
    Intervention: Drug: Tranexamic Acid
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 27, 2017)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 16, 2017
Estimated Primary Completion Date August 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult patients over age 18 and scheduled for open lumbar spine surgery (primary or revision)
  • Must be able to swallow tablets

Exclusion Criteria

  • Known allergy to TXA
  • History of renal failure or kidney transplant
  • History of arterial thromboembolic event (eg. myocardial infarction, stroke) within the past year
  • Placement of an arterial stent within the past year
  • History of blood clots (DVT, PE) within the past year
  • Refusal to receive blood products
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03037515
Other Study ID Numbers  ICMJE 10608
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stephen Bartol, Henry Ford Health System
Study Sponsor  ICMJE Henry Ford Health System
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Henry Ford Health System
Verification Date January 2017

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