Tranexamic Acid to Reduce Blood Loss in Spine Surgery

Part of paid clinical trials in San Francisco, California.

Sponsor
Columbia University
Study ID
NCT02314988
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Spinal Deformity
  • Spinal Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Tranexamic Acid — DRUG
    3.0 grams of tranexamic acid will be poured in the surgical field and left in contact for five minutes. Subsequently, excess study solution will be suctioned away without touching the surrounding tissue surfaces and then the would closed without irrigation or manipulation. TXA solution will be prepared using a dose of 3 grams of tranexamic acid combined with 70 mL of sterile normal saline, for a total volume of 100 mL.
  • Placebo — DRUG
    Placebo will be poured in the surgical field and left in contact for five minutes. Subsequently, excess solution will be suctioned away without touching the surrounding tissue surfaces and then the would closed without irrigation or manipulation. The placebo solution will be 100 mL of sterile normal saline.

Study Details

This study is designed to evaluate the efficacy of topical tranexamic acid to reduce perioperative blood loss, reduction in postoperative drain output and allogenic transfusion requirements. The proposed study will be a prospective, randomized, double-blind (subject, surgeons, investigators, research coordinators) placebo-controlled study. Patients requiring posterior spinal fusion will be enrolled for this study. Furthermore, patients undergoing elective complex deformity surgery will also be enrolled. Both populations of patients will be randomized into two groups. Group I will receive standard of care operative fixation with topical tranexamic acid intervention (test); Group II will receive standard of care operative fixation with normal saline (placebo) intervention. This study will have a 2-year follow-up and will consist of three periods: screening/enrollment phase up to 21 days from the day of injury to the day of randomization and operative intervention, an inpatient data collection period for 4 days postoperative, and then a follow-up period for 2-years postoperative (visits occurring at 16 weeks, 1 year, and 2 year) time points.

Key Dates

Start date
Jun 15, 2020
Status verified
May 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
252 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Intervention
    Subjects will receive tranexamic acid on the surgical wound.
  • Placebo Comparator: Placebo control
    Subjects will receive placebo (saline solution) on the surgical wound.

Primary Outcome Measure

Maximal drop in systemic hemoglobin concentration during the postoperative period [ Time Frame: Patients will be followed through postoperative day 4 ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of California San Francisco Medical CenterSan FranciscoCalifornia94149
Shane Burch, MD (PRINCIPAL_INVESTIGATOR)
Norton Leatherman Spine CenterLouisvilleKentucky40202
Charles H. Crawford, MD (PRINCIPAL_INVESTIGATOR)
NYP/The Allen Hospital - CUIMCNew YorkNew York10032
Ronald A. Lehman, MD
[email protected]
Ronald A. Lehman, MD (PRINCIPAL_INVESTIGATOR)
Duke University Medical CenterDurhamNorth Carolina27710
Christopher Shaffrey, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Francisco, CA

By research site
University of California San Francisco Medical Center· San Francisco, CANorton Leatherman Spine Center· Louisville, KYNYP/The Allen Hospital - CUIMC· New York, NYDuke University Medical Center· Durham, NC

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