RECRUITING

Tranexamic Acid in Adult Spinal Deformity Surgery

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Conditions

Spinal DeformityDegenerative Lumbar Spinal StenosisBlood Loss, Surgical

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Posterior spinal surgery for adult deformity is associated with high incidence of blood loss and need for blood transfusion and intraoperative blood salvage, with associated increased cost and risk for perioperative complications. Tranexamic acid (TXA) is relatively inexpensive anti-fibrinolytic agent that has been proven effective for decreasing intraoperative blood loss in various surgical specialties. Intravenous TXA (ivTXA) is routinely used at our institution for adult spinal deformity cases. Meanwhile, topical TXA (tTXA) is an attractive alternative/adjunct to ivTXA used with good results in orthopedic arthroplasty and cardiac surgery. To the investigators' knowledge, no data exists in the literature on the use of tTXA in either adult or pediatric spinal deformity surgery. The goal of this study is to determine the role tTXA has an adjunct to ivTXA in decreasing perioperative blood loss, drainage, transfusion requirements and length of stay following adult deformity spine surgery.

Official Title

Topical Tranexamic Acid as a Adjunct to Intravenous Tranexamic Acid in Adult Spinal Deformity Surgery

Quick Facts

Study Start:2018-07-11
Study Completion:2025-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03553186

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18-80
  2. * Scheduled to undergo posterior long segment ( ≥ 5 levels) posterior spinal fusion for adult scoliosis or degenerative joint diseae
  3. * + fusion to pelvis
  1. * Surgical factors:
  2. * Anterior Approach
  3. * Presence or history of dural tear without repair as evidenced by pseudomeningocele on MRI imaging or by intraoperative exploration
  4. * Patients donating autologous blood preoperatively
  5. * Diagnosis of renal (Cr\>1.5 or CrCl \<30ml/min) or hepatic insufficiency (AST, ALT 2x upper limit of normal)
  6. * Diagnosis of seizure disorder or prior seizure
  7. * History of thromboembolic events (CVA, TIA, DVT, PE) if within 1 year of surgery
  8. * Hypercoagulability (e.g. antiphospholipid syndrome)
  9. * History of coronary artery disease (stent, MI, +stress test) within 1 year of surgery
  10. * Atrial fibrillation
  11. * Concurrent anticoagulation therapy that cannot be discontinued within 3 days before surgery (Coumadin, plavix, LVX)
  12. * Concurrent anticoagulation with ASA 325 that cannot be discontinued 10 days before surgery
  13. * Bleeding disorder or abnormal preoperative coagulation profile (as identified by a preoperative platelet count of \<100,000/mm3, an international normalized ratio of \>1.4, or a prolonged partial thromboplastin time \>1.4 times normal)
  14. * Preexisting anemia \<10 g/dL
  15. * Color blindness or disturbance of color vision
  16. * Leukemia or active cancer
  17. * Religious restrictions on blood transfusion
  18. * Pregnancy or women who are lactating/breastfeeding

Contacts and Locations

Study Contact

Jordan A Gruskay, MD
CONTACT
2034647759
gruskayj@hss.edu
Evangelia Zgonia, BA
CONTACT
2127742837
zgonise@hss.edu

Principal Investigator

Han Jo Kim, MD
PRINCIPAL_INVESTIGATOR
Department of Spine Surgery

Study Locations (Sites)

Hospital for Special Surgery
New York, New York, 10021
United States

Collaborators and Investigators

Sponsor: Hospital for Special Surgery, New York

  • Han Jo Kim, MD, PRINCIPAL_INVESTIGATOR, Department of Spine Surgery

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-07-11
Study Completion Date2025-03

Study Record Updates

Study Start Date2018-07-11
Study Completion Date2025-03

Terms related to this study

Additional Relevant MeSH Terms

  • Spinal Deformity
  • Degenerative Lumbar Spinal Stenosis
  • Blood Loss, Surgical