Tranexamic Acid in Adult Spinal Deformity Surgery
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHospital for Special Surgery, New York
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-80
Scheduled to undergo posterior long segment ( ≥ 5 levels) posterior spinal fusion for adult scoliosis or degenerative joint diseae
+ fusion to pelvis
Disqualifiers
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
Diagnosis of renal (Cr>1.5 or CrCl <30ml/min) or hepatic insufficiency (AST, ALT 2x upper limit of normal)
Trial design
Design model
Parallel
Treatments tested in this trial
Tranexamic Acid 100 MG/ML
DrugTXA 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.
Placebo
DrugPlacebo 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: ivTXA + topical TXAExperimental treatment 1 intervention
Group B: IV TXA + topical placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Postoperative Drain output
Drain Output
Time frame
48 hoursSecondary outcomes
1
Perioperative blood transfusion
Number of units of blood transfused perioperatively, including cell saver administration
Time frame
Up to 30 days postoperatively2
Perioperative blood drop
CBC with hct/hg tracked postoperatively
Time frame
Up to 72 hours postoperatively3
Perioperative adverse events
Minor and major adverse events occuring during hospitalization or after discharge
Time frame
Up to 30 days postoperatively4
Length of stay
\# of days from surgery to discharge
Time frame
Up to 30 days postoperativelySponsors and contacts
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Source ClinicalTrials.gov