Tranexamic Acid in Adult Spinal Deformity Surgery

Topical Tranexamic Acid as a Adjunct to Intravenous Tranexamic Acid in Adult Spinal Deformity Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Blood Loss, Surgical; Spinal Deformity; Degenerative Lumbar Spinal Stenosis
• Intervention / Treatment: Drug: Tranexamic Acid 100 MG/ML; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jordan A Gruskay, MD; Phone Number: 2034647759; Email: gruskayj@hss.edu
• Study Contact Backup: Name: Evangelia Zgonia, BA; Phone Number: 2127742837; Email: zgonise@hss.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Recruiting
      • Hospital for Special Surgery
      • Contact: Evangelia Zgonis
      • Principal Investigator: Han Jo Kim, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ivTXA + topical TXA; TXA lavage solution (200 cc sterile normal saline + 5 g tranexamic acid 100mg/ml (50cc)) will be poured into the surgical field and left in contact for five minutes. This will occur after instrumentation. Excess solution will be suctioned away using a non-cell saver suction. IV txa will be given as (5mg/ml) loading dose (20mg/kg) over 15 minutes followed by 2 mg/kg/hr maintenance dosing as per hospital protocol	Drug: Tranexamic Acid 100 MG/ML; TXA lavage solution (200 cc sterile normal saline + 5 g tranexamic acid 100mg/ml (50cc)) will be poured into the surgical field and left in contact for five minutes. This will occur after instrumentation. Excess solution will be suctioned away using a non-cell saver suction.; Other Names: Intervention group
Placebo Comparator: IV TXA + topical placebo; Placebo solution (200 cc sterile normal saline + placebo TXA ampule (normal saline) (50cc)) will be poured into the surgical field and left in contact for five minutes. This will occur after pedicle screw instrumentation. Excess solution will be suctioned away using a non-cell saver suction. IV txa will be given as (5mg/ml) loading dose (20mg/kg) over 15 minutes followed by 2mg/kg/hr maintenance dosing as per hospital protocol	Drug: Placebo; Placebo solution (200 cc sterile normal saline + placebo TXA ampule (50cc)) will be poured into the surgical field and left in contact for five minutes. This will occur after pedicle screw instrumentation. Excess solution will be suctioned away using a non-cell saver suction.; Other Names: Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Drain output	Drain Output	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative blood transfusion	Number of units of blood transfused perioperatively, including cell saver administration	Up to 30 days postoperatively
Perioperative blood drop	CBC with hct/hg tracked postoperatively	Up to 72 hours postoperatively
Perioperative adverse events	Minor and major adverse events occuring during hospitalization or after discharge	Up to 30 days postoperatively
Length of stay	# of days from surgery to discharge	Up to 30 days postoperatively

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York
• Investigators: Principal Investigator: Han Jo Kim, MD, Department of Spine Surgery

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2018
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: May 29, 2018
• First Submitted That Met QC Criteria: June 11, 2018
• First Posted (Actual): June 12, 2018

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intraoperative Complications; Congenital Abnormalities; Spinal Stenosis; Blood Loss, Surgical; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 2017-0920

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes