Tranexamic Acid Infusion During Elective Spine Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Tranexamic Acid Infusion During Elective Spine Surgery

Conditions
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Spine Surgery

Intervention / Treatment
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* Drug: Tranexamic Acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Patient will receive no transexemic acid of any kind | |
| Experimental: IV-transexemic acid<br>weight adjusted standard dose of TXA will be administered to these subset of patients prior to incision in IV-form | Drug: Tranexamic Acid<br>* IV and topical form of TXA will be administered to patients in the respective groups.<br>|
| Experimental: Topical-transexemic acid<br>the wound site after the surgery is completed will be bathed in TXA for a standardized period of time prior to skin closure | Drug: Tranexamic Acid<br>* IV and topical form of TXA will be administered to patients in the respective groups.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drain output | Drains will be placed during surgery, this will be recorded by nursing staff on a regular schedule and we will assess the results as a surrogate for blood loss post operatively | 48 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hematocrit | Labs will be recorded each morning after the surgery, this includes hematocrit | two days post operatively | 
| Change in hemoglobin | Labs will be recorded each morning after the surgery, this includes hemoglobin | two days post operatively | 
| Emergency department visits | We will assess which treatment arms, if any had increased rate of Emergency department visits for any reason | 30 days post operatively | 
| number of hospital readmissions | We will assess which treatment arms, if any had increased rate of readmission to the hospital | 30 days post operatively | 
| Incidence of PE | We will assess is any treatment arm had an increased risk of PE | 30 days post opertively | 
| Incidence of DVT | We will assess is any treatment arm had an increased risk of DVT | 30 days post opertively |