The Use of Tranexamic Acid to Reduce Perioperative Blood Loss During High Risk Spine Fusion Surgery (TXA)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Dhanesh Gupta, Northwestern University
ClinicalTrials.gov Identifier:
NCT01728636
First received: November 9, 2012
Last updated: March 14, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Curvature of Spine
Drug: Tranexamic Acid
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of Tranexamic Acid to Reduce Perioperative Blood Loss During High Risk Spine Fusion Surgery

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Total Red Blood Cells Transfused in the Perioperative Period [ Time Frame: 24 hours after skin incision ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Additional blood product transfused (Fresh frozen plasma, Cryoprecipitate, and Platelets) [ Time Frame: 24 hours after skin incision ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Adjunctive procoagulant medications [ Time Frame: 24 hours after skin incision ] [ Designated as safety issue: No ]
    DDAVP and rFVIIa administration

  • Estimated Intraoperative Blood Loss [ Time Frame: 24 hours after skin incision ] [ Designated as safety issue: No ]
  • Postoperative Blood loss [ Time Frame: 24 hours after skin incision ] [ Designated as safety issue: No ]
  • Intravenous Fluid Administration [ Time Frame: 24 hours after skin incision ] [ Designated as safety issue: No ]
  • Incidence of cerebral, cardiac, or renal thromboembolism prior to discharge [ Time Frame: 120 hours after skin incision ] [ Designated as safety issue: Yes ]
  • Incidence of venous thromboembolism [ Time Frame: 120 hours after skin incision ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 170
Study Start Date: January 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tranexamic Acid
Tranexamic acid 10mg/kg loading dose given pre-incision and 1mg/kg/hr infusion throughout intraoperative period
Drug: Tranexamic Acid
none
Other Name: Lysteda
Placebo Comparator: Placebo
Normal saline placebo loading dose 0.5ml/kg and infusion at 0.5ml/kg/hr throughout operative course

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01728636

Locations
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Louanne M Carabini, MD Northwestern University Feinberg School of Medicine
  More Information

Publications:

Responsible Party: Dhanesh Gupta, Associate Professor of Anesthesiology & Neurological Surgery, Northwestern University
ClinicalTrials.gov Identifier: NCT01728636     History of Changes
Other Study ID Numbers: STU00066949
Study First Received: November 9, 2012
Last Updated: March 14, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014