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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
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Curvature of Spine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 9, 2012
Last Updated
January 5, 2021
Sponsor
Northwestern University
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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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PubMed Identifier
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Citation
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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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