The Use of Tranexamic Acid to Reduce Perioperative Blood Loss During High Risk Spine Fusion Surgery (TXA)
Primary Purpose
Curvature of Spine
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tranexamic Acid
Sponsored by
About this trial
This is an interventional treatment trial for Curvature of Spine
Eligibility Criteria
Inclusion Criteria:
- age>17 years
- undergoing posterior spine fusion surgery for kyphoscoliosis with a >80% chance of major transfusion
Exclusion Criteria:
- age < 18 years
- non-English speaking
- pregnancy
- emergency procedures
- surgery for tumor, trauma or infection
- severe coronary artery disease
- history of venous thromboembolism
- history of cerebral vascular accident
- history of renal insufficiency
- allergy to tranexamic acid
Sites / Locations
- Northwestern Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Tranexamic Acid
Placebo
Arm Description
Tranexamic acid 10mg/kg loading dose given pre-incision and 1mg/kg/hr infusion throughout intraoperative period
Normal saline placebo loading dose 0.5ml/kg and infusion at 0.5ml/kg/hr throughout operative course
Outcomes
Primary Outcome Measures
Total Red Blood Cells Transfused in the Intraoperative Period
Total red blood cells transfused in the intraoperative period in (mL). Total RBC equal packed red blood cells and cell saver infusion.
Secondary Outcome Measures
Additional Blood Products Transfused
Total additional blood products (fresh frozen plasma, cryoprecipitate, and platelets) transfused in the perioperative period measured in units.
Post Operative Major Morbidity
Number of participants who experienced arterial or venous thromboembolism, neurologic complications (including stroke, seizure,and delirium), infections, and pulmonary renal or cardiac adverse outcomes (demand ischemia, myocardial infarction or new arrhythmia) before another operative procedure or hospital discharge.
Full Information
NCT ID
NCT01728636
First Posted
November 9, 2012
Last Updated
January 5, 2021
Sponsor
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT01728636
Brief Title
The Use of Tranexamic Acid to Reduce Perioperative Blood Loss During High Risk Spine Fusion Surgery
Acronym
TXA
Official Title
The Use of Tranexamic Acid to Reduce Perioperative Blood Loss During High Risk Spine Fusion Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 15, 2013 (Actual)
Primary Completion Date
December 30, 2017 (Actual)
Study Completion Date
December 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if tranexamic acid reduces perioperative blood loss and red blood cell transfusion during high risk spine surgery.
Detailed Description
There are conflicting studies in the literature reporting different efficacy outcomes for the use of antifibrinolytics in spine fusion surgery. Several studies support the successful use of tranexamic acid for major orthopedic procedures, but the patient populations studied for spine surgery thus far have been small and highly variable, with less than clinically significant results. If TXA if efficacious in reducing not only perioperative blood loss, but RBC transfusion without an increase in thromboembolic events, then its use may be justified for patients at risk for major blood transfusion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Curvature of Spine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tranexamic Acid
Arm Type
Experimental
Arm Description
Tranexamic acid 10mg/kg loading dose given pre-incision and 1mg/kg/hr infusion throughout intraoperative period
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Normal saline placebo loading dose 0.5ml/kg and infusion at 0.5ml/kg/hr throughout operative course
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Other Intervention Name(s)
Lysteda
Intervention Description
intravenous administration of bolus and infusion for duration of surgical procedure
Primary Outcome Measure Information:
Title
Total Red Blood Cells Transfused in the Intraoperative Period
Description
Total red blood cells transfused in the intraoperative period in (mL). Total RBC equal packed red blood cells and cell saver infusion.
Time Frame
Intraoperative period (approximately 12 hours)
Secondary Outcome Measure Information:
Title
Additional Blood Products Transfused
Description
Total additional blood products (fresh frozen plasma, cryoprecipitate, and platelets) transfused in the perioperative period measured in units.
Time Frame
24 hours after skin incision
Title
Post Operative Major Morbidity
Description
Number of participants who experienced arterial or venous thromboembolism, neurologic complications (including stroke, seizure,and delirium), infections, and pulmonary renal or cardiac adverse outcomes (demand ischemia, myocardial infarction or new arrhythmia) before another operative procedure or hospital discharge.
Time Frame
Time of surgery to date of discharge from hospital (average 7 days)
Other Pre-specified Outcome Measures:
Title
Estimated Intraoperative Blood Loss
Description
Estimated Intraoperative blood loss in milliliters (mLs)
Time Frame
Incision to skin closure (approximately 10 hours)
Title
Total Tranexamic Acid Dose (mg)
Description
Total milligrams of intravenous tranexamic acid administered during the surgical procedure.
Time Frame
Intraoperative period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age>17 years
undergoing posterior spine fusion surgery for kyphoscoliosis with a >80% chance of major transfusion
Exclusion Criteria:
age < 18 years
non-English speaking
pregnancy
emergency procedures
surgery for tumor, trauma or infection
severe coronary artery disease
history of venous thromboembolism
history of cerebral vascular accident
history of renal insufficiency
allergy to tranexamic acid
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louanne M Carabini, MD
Organizational Affiliation
Northwestern University Feinberg School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20407351
Citation
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The Use of Tranexamic Acid to Reduce Perioperative Blood Loss During High Risk Spine Fusion Surgery
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