Tranexamic Acid in Adult Spinal Deformity Surgery

NCT03553186 | Recruiting Phase 3 FDA Drug

• 1 other identifier: 2017-0920
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Loss, Surgical; Spinal Deformity; Degenerative Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

• Postoperative Drain output

  Drain Output

  48 hours

Secondary Outcomes (4)

• Perioperative blood transfusion

  Up to 30 days postoperatively

• Perioperative blood drop

  Up to 72 hours postoperatively

• Perioperative adverse events

  Up to 30 days postoperatively

• Length of stay

  Up to 30 days postoperatively

Study Arms (2)

ivTXA + topical TXA

EXPERIMENTAL

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

IV TXA + topical placebo

PLACEBO COMPARATOR

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

Interventions

Tranexamic Acid 100 MG/ML DRUG

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.

Also known as: Intervention group

ivTXA + topical TXA

Placebo DRUG

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.

Also known as: Control group

IV TXA + topical placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80
• Scheduled to undergo posterior long segment ( ≥ 5 levels) posterior spinal fusion for adult scoliosis or degenerative joint diseae
• \+ fusion to pelvis

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

RECRUITING

MeSH Terms

Conditions

Blood Loss, Surgical

Interventions

Tranexamic Acid; Control Groups

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Han Jo Kim, MD

  Department of Spine Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jordan A Gruskay, MD

CONTACT

2034647759; gruskayj@hss.edu

Evangelia Zgonia, BA

CONTACT

2127742837; zgonise@hss.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Simple blinded randomization will occur by the pharmacy prior to distribution of the intervention drug.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: June 12, 2018
• Study Start: July 11, 2018
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)