Tranexamic Acid Infusion During Elective Spine Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tranexamic Acid.
- Who it may be relevant to
- Registry conditions: Spine Surgery. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
This will be a prospective randomized control, double-blinded investigation. The Investigators will recruit patients undergoing elective, primary, decompressive lumbar surgery via a posterior surgical approach of less than 3 levels. This includes patients undergoing decompressive lumbar laminectomies with or without fusion. Fusion may include posterior interbody and/or posterior lateral techniques with instrumentation.
There will be 3 treatment arms with the goal of 65 patients in each arm. Patients will be randomized pre-operatively and enrolled into the IV transexamic acid group (receiving intraoperative intravenous tranexamic acid infusion), or the topical transexamic acid group or the control/placebo group (receiving intraoperative intravenous saline). The Investigators expect the duration of each treatment group to be approximately 4-5 months. Therefore, the study should be completed within 1.5 years. The primary surgeon and anesthesia staff will not be blinded to the treatment arm due to the nature of the different administration routes, but post-operative nursing staff will be blinded to administration routes.
Interventions
- Drug Tranexamic Acid
IV and topical form of TXA will be administered to patients in the respective groups.
Primary outcome measures
- Drain output [Time frame: 48 hours postoperatively]
Secondary outcome measures (6)
- Change in hematocrit [Time frame: two days post operatively]
- Change in hemoglobin [Time frame: two days post operatively]
- Emergency department visits [Time frame: 30 days post operatively]
- number of hospital readmissions [Time frame: 30 days post operatively]
- Incidence of PE [Time frame: 30 days post opertively]
- Incidence of DVT [Time frame: 30 days post opertively]
Eligibility criteria
Inclusion criteria
- Patients undergoing decompressive lumbar laminectomy with or without fusion
- Primary surgical procedure
- Competent adult able to give informed consent
- Age >18
Exclusion criteria
- h/o DVT or PE
- h/o seizure
- h/o coagulopathy
- Diagnosis of malignancy or infection as indication for surgical decompression
- Abnormal pre-operative PT/INR, aPTT, bleeding time
- Platelet count < 100
- Patients requiring therapeutic heparin or lovenox bridges prior to and/or after surgery
- Allergy to TXA
- Pregnant women and prisoners
- Renal insufficiency
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Albany Medical Center — Albany
Identifiers
NCT: NCT04312880 · 5176