Tranexamic Acid in Adult Spinal Deformity Surgery

Blood loss is a significant issue in spinal deformity surgery, often requiring allogenic
blood transfusion and/or intraoperative blood salvage and leading to increased risk of
postoperative morbidity, increased length of stay, and higher total hospital costs.
Tranexamic acid is an antifibrinolytic agent that is used in many surgical specialties to
prevent perioperative blood loss. Intravenous (ivTXA) dosing has proven effective in reducing
blood loss and perioperative transfusion in spinal surgery, while the topical (tTXA) form has
been shown to be at least non-inferior to IV transfusion in the total arthroplasty
literature. Intravenous TXA is routinely used at the investigators' institution in spinal
deformity cases, but even with ivTXA infusion, perioperative blood loss remains a significant
issue, with total estimated and calculated blood loss between ~1500-3000 mL. Usage of local
tTXA in addition to ivTXA may provide additional benefits including an additive effect on
decreasing blood loss, allowing for lowered dosages of ivTXA, decreasing risks associated
with systemic exposure. Combination ivTXA and tTXA has shown excellent results in total joint
arthroplasty. The objective of this study is to determine the additive benefit and risks of
co-administration of the two in spinal deformity surgery. This population of spinal patients
was chosen because the estimated blood loss is high and the potential clinical benefit of the
intervention is large. Patients will be enrolled if they are undergoing surgery > 5 levels
with extension to the pelvis. The investigators have previously utilized topical TXA for
these cases by applying operative sponges soaked with solution into the wound during routine
x-ray check following instrumentation, with anecdotally good effect. However, this practice
has not been prospectively studied. In this prospective, randomized, blinded, placebo
controlled study, a similar combined effect of ivTXA and tTXA on decreasing perioperative
blood loss as seen in total joint arthroplasty, with a similar safety profile is expected.

Inclusion Criteria:

- Age 18-80

- Scheduled to undergo posterior long segment ( ≥ 5 levels) posterior spinal fusion for
adult scoliosis or degenerative joint diseae

- + fusion to pelvis

Exclusion Criteria:

- Surgical factors:

- Anterior Approach

- Three column osteotomy (VCR, PSO)

- Presence or history of dural tear

- Patients donating autologous blood preoperatively

Patient factors:

- Diagnosis of renal (Cr>1.5 or CrCl <30ml/min) or hepatic insufficiency (AST, ALT 2x
upper limit of normal)

- Diagnosis of seizure disorder or prior seizure

- History of thromboembolic events (CVA, TIA, DVT, PE)

- Hypercoagulability (e.g. antiphospholipid syndrome)

- History of coronary artery disease (stent, MI, +stress test or A-fib

- Concurrent anticoagulation therapy that cannot be discontinued within 3 days before
surgery (Coumadin, plavix, LVX)

- Concurrent anticoagulation with ASA 325 that cannot be discontinued 10 days before
surgery

- Bleeding disorder or abnormal preoperative coagulation profile (as identified by a
preoperative platelet count of <100,000/mm3, an international normalized ratio of
>1.4, or a prolonged partial thromboplastin time >1.4 times normal)

- Preexisting anemia <10 g/dL

- Color blindness or disturbance of color vision

- Leukemia or active cancer

- Religious restrictions on blood transfusion

- Pregnancy or women who are lactating/breastfeeding

- Women on hormonal contraceptives