TXA in Spinal Fusion

Study Overview
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Brief Summary
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Tranexamic acid and placebo will be given during surgery to patients who have elected to undergo lumber interbody fusion on 2 or more levels. Information regarding blood loss, transfusions needed, postoperative cognitive status (including delirium), postoperative markers of systemic inflammation and duration of hospital stay will be collected.

Detailed Description
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This study is to assess whether tranexamic acid (a drug that is used to coagulate the blood and reduce bleeding) use in lumbar spinal fusion can reduce blood loss and postoperative delirium compared to placebo. Thusly reducing need for transfusion, shorting the hospital stay and improving outcomes. For this the study will randomize patients who are receiving elective lumbar interbody fusion (PLIF or TLIF) of 2 or more levels for degenerative disc disease (DDD) into 2 groups. Group 1 would receive tranexamic acid during the surgery while group 2 will receive placebo. Blood loss during the surgery and postoperatively (while the patient has a drain) will be monitored along with the amount of transfusions needed, postoperative cognitive status (including delirium), postoperative markers of systemic inflammation, and and the duration of hospital stay. Delirium incidence and severity will be assessed daily for the first 5 days after surgery and at discharge. Cognitive status (neuropsychological tests) will be assessed at post-discharge follow up visits and compared to preoperative status. The drug or placebo are only given during the surgery. The patient population includes elective cases of patient undergoing lumbar spinal fusion of 2 or more levels. Spinal fusions are known to be associated with blood loss, especially when the surgeries are long and more levels need to be fused.

Official Title
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Prospective, Randomized, Double Blind Study on the Effects of Tranexamic Acid on Intraoperative Blood Loss During Lumbar Spinal Fusion And Instrumentation

Conditions
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Degenerative Disc Disease

Intervention / Treatment
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* Drug: Tranexamic Acid
* Drug: Saline Solution
* Diagnostic Test: Visual Acuity Exam
* Diagnostic Test: 3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-90 years American Spinal Injury Association (ASA) Impairment Scale anesthesia risk of I to IV Patients undergoing 2 or more levels of posterior lumbar interbody fusion for DDD. This includes PLIF or TLIF. Patients have failed conservative management, which include physical therapy (PT) or occupational therapy (OT) and/or injections. Exclusion Criteria: ASA class V Patient unable to consent Patient with chronic kidney disease stage III or above: baseline plasma creatinine>1.5mg/dL Patient with known liver failure Patients on anticoagulation or dual antiplatelets (presence of vascular stents). Patients with artificial valves. Patients with allergy to TXA Patients with platelet count < 150 000, Patients with PT>15s Patients with Activated Partial Thromboplastin Time (APPT) >38s History of stroke or (an) unprovoked thromboembolic event(s). History of intracranial bleeding, Pregnancy known defective color vision history of venous or arterial thromboembolism or active thromboembolic disease Patients with severe pulmonary or cardiac disease. Patients who refuse transfusion of blood products Patients with chronic anemia with Hg<8 Patients undergoing lumbar fusion for disease other than DDD (neoplasm) Patients undergoing lumbar fusion by anterior or lateral approach. Minimally invasive TLIF are excluded. Emergent cases. Women on hormonal contraception Retinal vein or artery occlusion Hypercoagulability Seizure disorder Current use of tretinoin Current use of chlorpromazine Breast feeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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
Interventional Model Description: Phase 2B randomized, single-center, double-blinded, placebo vs treatment clinical trial with 1:1 randomization
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment<br>1:1 randomization, given tranexamic acid during surgery, visual acuity exam | Drug: Tranexamic Acid<br>* Antifibrinolytic Agent<br>* Other names: Cyklokapron;Diagnostic Test: Visual Acuity Exam<br>* Supplemented into standard of care daily neurological exam on day of surgery and day after<br>* Other names: Eye Exam;Diagnostic Test: 3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)<br>* 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.<br>|
| Placebo Comparator: Placebo<br>1:1 randomization, given standard of care treatment during surgery, visual acuity exam | Drug: Saline Solution<br>* Placebo<br>Diagnostic Test: Visual Acuity Exam<br>* Supplemented into standard of care daily neurological exam on day of surgery and day after<br>* Other names: Eye Exam;Diagnostic Test: 3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)<br>* 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transfusion | Amount (in cells cubed) of red blood cells (RBC) transfused intraoperatively and up to 7 days post-operatively | Up to 7 days | 
| Blood Loss | Amount (in cells cubed) of blood loss intraoperatively and up to 7 days post-operatively | Up to 7 days or until discharge | 
| Delirium | Delirium incidence (yes/no) and severity (score 0-20) using daily 3D-CAM delirium assessment instrument. | up to 7 days or discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Posterior Lumbar Interbody Fusion, Transforaminal Lumbar Interbody Fusion, Tranexamic Acid, Neurosurgery, Delirium