Clinical trial NCT03553186: Tranexamic Acid in Adult Spinal Deformity Surgery
Official title: Topical Tranexamic Acid as a Adjunct to Intravenous Tranexamic Acid in Adult Spinal Deformity Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Spinal Deformity
Degenerative Lumbar Spinal Stenosis
Blood Loss, Surgical
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2018-06-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Posterior spinal surgery for adult deformity is associated with high incidence of blood loss and need for blood transfusion and intraoperative blood salvage, with associated increased cost and risk for perioperative complications. Tranexamic acid (TXA) is relatively inexpensive anti-fibrinolytic agent that has been proven effective for decreasing intraoperative blood loss in various surgical specialties. Intravenous TXA (ivTXA) is routinely used at our institution for adult spinal deformity cases. Meanwhile, topical TXA (tTXA) is an attractive alternative/adjunct to ivTXA used with good results in orthopedic arthroplasty and cardiac surgery. To the investigators' knowledge, no data exists in the literature on the use of tTXA in either adult or pediatric spinal deformity surgery. The goal of this study is to determine the role tTXA has an adjunct to ivTXA in decreasing perioperative blood loss, drainage, transfusion requirements and length of stay following adult deformity spine surgery.

Detailed description: 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.

Eligibility criteria: 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
  * Presence or history of dural tear without repair as evidenced by pseudomeningocele on MRI imaging or by intraoperative exploration
  * 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) if within 1 year of surgery
* Hypercoagulability (e.g. antiphospholipid syndrome)
* History of coronary artery disease (stent, MI, +stress test) within 1 year of surgery
* Atrial fibrillation
* 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

Primary outcomes:
measure: Postoperative Drain output
timeFrame: 48 hours
Secondary outcomes:
measure: Perioperative blood transfusion
timeFrame: Up to 30 days postoperatively
measure: Perioperative blood drop
timeFrame: Up to 72 hours postoperatively
measure: Perioperative adverse events
timeFrame: Up to 30 days postoperatively
measure: Length of stay
timeFrame: Up to 30 days postoperatively
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Department of Spine Surgery
name: Han Jo Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: