Tranexamic Acid Infusion During Elective Spine Surgery

Part of paid clinical trials in Albany, New York.

Sponsor
Albany Medical College
Study ID
NCT04312880
Phase
PHASE4
Status
Enrolling By Invitation

Conditions

  • Spine Surgery

Eligibility Criteria

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

Interventions

  • Tranexamic Acid — DRUG
    IV and topical form of TXA will be administered to patients in the respective groups.

Study Details

Tranexamic acid (TXA) is an agent that has been shown to be safe and effective to reduce blood loss in surgical procedures. The purpose of the study is to assess the effect of transexamic on elective decompressive lumbar spine surgery with and without fusion.

Key Dates

Start date
Dec 1, 2018
Status verified
Aug 2020
Primary completion
Jan 1, 2021
Completion
Jan 1, 2021

Study Design

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

Arms

  • No Intervention: Control
    Patient will receive no transexemic acid of any kind
  • Experimental: IV-transexemic acid
    weight adjusted standard dose of TXA will be administered to these subset of patients prior to incision in IV-form
  • Experimental: Topical-transexemic acid
    the wound site after the surgery is completed will be bathed in TXA for a standardized period of time prior to skin closure

Primary Outcome Measure

Drain output [ Time Frame: 48 hours postoperatively ]

Locations (1)

FacilityCityStateZIPSite coordinators
Albany Medical CenterAlbanyNew York12208-

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By research site
Albany Medical Center· Albany, NY

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