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Trial record 24 of 419 for:    TRANEXAMIC ACID

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

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.

Condition or disease Intervention/treatment Phase
Blood Loss, Surgical Blood Loss Anemia Drug: Tranexamic Acid Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of Oral and Intravenous Tranexamic Acid in Lumbar Spine Surgery
Estimated Study Start Date : February 15, 2017
Estimated Primary Completion Date : August 15, 2017
Estimated Study Completion Date : November 16, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
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.
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

Active Comparator: Oral Tranexamic Acid
The oral TXA group will receive 1950 mg TXA (3 tablets of 650 mg) approximately 2 hours before incision.
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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Post-operative drop in hemoglobin between the two groups [ Time Frame: 1 day after surgery until patient is discharged, up to 7 days ]
  2. Post-operative blood loss between the two groups [ Time Frame: 1 day after surgery until patient is discharged, up to 7 days ]
  3. Number of units transfused between the two groups [ Time Frame: 1 day after surgery until patient is discharged, up to 7 days ]
  4. Post-operative drain output between the two groups [ Time Frame: 1 day after surgery until patient is discharged, up to 7 days ]
  5. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03037515


Contacts
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Contact: Charles C Yu, MD 314-614-3536 cyu1@hfhs.org

Sponsors and Collaborators
Henry Ford Health System

Publications:
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Responsible Party: Stephen Bartol, Orthopaedic Spine Surgeon, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT03037515     History of Changes
Other Study ID Numbers: 10608
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemorrhage
Blood Loss, Surgical
Pathologic Processes
Intraoperative Complications
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants