Oral and Intravenous Tranexamic Acid in Lumbar Spine Surgery
Primary Purpose
Blood Loss, Surgical, Blood Loss Anemia
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Tranexamic Acid
Sponsored by
About this trial
This is an interventional prevention trial for Blood Loss, Surgical
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Intravenous Tranexamic Acid
Oral Tranexamic Acid
Arm Description
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.
The oral TXA group will receive 1950 mg TXA (3 tablets of 650 mg) approximately 2 hours before incision.
Outcomes
Primary Outcome Measures
Intra-operative blood loss between the two groups
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
Post-operative drop in hemoglobin between the two groups
Post-operative blood loss between the two groups
Number of units transfused between the two groups
Post-operative drain output between the two groups
Incidence of thromboembolic events between the two groups
Full Information
NCT ID
NCT03037515
First Posted
January 23, 2017
Last Updated
January 27, 2017
Sponsor
Henry Ford Health System
1. Study Identification
Unique Protocol Identification Number
NCT03037515
Brief Title
Oral and Intravenous Tranexamic Acid in Lumbar Spine Surgery
Official Title
A Randomized Controlled Trial of Oral and Intravenous Tranexamic Acid in Lumbar Spine Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 15, 2017 (Anticipated)
Primary Completion Date
August 15, 2017 (Anticipated)
Study Completion Date
November 16, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss, Surgical, Blood Loss Anemia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intravenous Tranexamic Acid
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Oral Tranexamic Acid
Arm Type
Active Comparator
Arm Description
The oral TXA group will receive 1950 mg TXA (3 tablets of 650 mg) approximately 2 hours before incision.
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Other Intervention Name(s)
Lysteda
Intervention Description
To identify if intravenous tranexamic acid is superior to oral tranexamic acid in reducing blood loss and need for transfusion in lumbar spine surgery.
Primary Outcome Measure Information:
Title
Intra-operative blood loss between the two groups
Description
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)
Time Frame
Day of surgery to 1 day after surgery, up to 7 days
Secondary Outcome Measure Information:
Title
Post-operative drop in hemoglobin between the two groups
Time Frame
1 day after surgery until patient is discharged, up to 7 days
Title
Post-operative blood loss between the two groups
Time Frame
1 day after surgery until patient is discharged, up to 7 days
Title
Number of units transfused between the two groups
Time Frame
1 day after surgery until patient is discharged, up to 7 days
Title
Post-operative drain output between the two groups
Time Frame
1 day after surgery until patient is discharged, up to 7 days
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charles C Yu, MD
Phone
314-614-3536
Email
cyu1@hfhs.org
12. IPD Sharing Statement
Citations:
PubMed Identifier
21936146
Citation
Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. No abstract available.
Results Reference
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PubMed Identifier
12697586
Citation
Good L, Peterson E, Lisander B. Tranexamic acid decreases external blood loss but not hidden blood loss in total knee replacement. Br J Anaesth. 2003 May;90(5):596-9. doi: 10.1093/bja/aeg111.
Results Reference
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Oral and Intravenous Tranexamic Acid in Lumbar Spine Surgery
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