TXA in Spinal Fusion

Phase 2

Completed

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

Brief Summary: 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: 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 occurrence and severity will be assessed daily for the first 5 days after surgery or at discharge, whichever comes first. 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Treatment	Visual Acuity Exam	1:1 randomization, given tranexamic acid during surgery, visual acuity exam
Placebo	Visual Acuity Exam	1:1 randomization, given standard of care treatment during surgery, visual acuity exam
Placebo	3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)	1:1 randomization, given standard of care treatment during surgery, visual acuity exam
Placebo	Saline Solution	1:1 randomization, given standard of care treatment during surgery, visual acuity exam
Treatment	Tranexamic Acid	1:1 randomization, given tranexamic acid during surgery, visual acuity exam
Treatment	3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)	1:1 randomization, given tranexamic acid during surgery, visual acuity exam

Primary Outcome Measures

Name	Time	Method
Delirium Occurrence	Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported	Delirium occurrence (yes/no) using daily 3D-CAM delirium assessment instrument.
Transfusion	Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported	The number of participants who had red blood cells (RBC) transfused: 1. Intraoperatively 2. Postoperatively (prior to discharge or at day 5, whichever occurred first) 3. Either Intraoperatively or Postoperatively
Blood Loss	Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported	Amount of blood loss: 1. Intraoperatively 2. Postoperatively (prior to discharge or at day 5, whichever occurred first) 3. Either Intraoperatively or Postoperatively

Secondary Outcome Measures

Name	Time	Method
Length of Postoperative Stay Prior to Discharge	Days thru day of discharge	Length of postoperative stay prior to discharge in days
Delirium Severity	Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported	Severity (score 0-20) using daily 3D-CAM delirium assessment instrument. Minimum=0 (no delirium) Maximum=20 (worse delirium)
Change in Interleukin-6 Concentration.	Preoperatively and 24 hours postoperatively	Measure of systemic inflammation using Interleukin-6 change between preoperative and 24 postoperatively blood draw.