Tranexamic Acid in Adult Spinal Deformity Surgery

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

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.
• 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.

Study Details

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.

Key Dates

Start date

Jul 11, 2018

Status verified

Mar 2026

Primary completion

Mar 31, 2027

Completion

Mar 31, 2027

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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
• 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

Primary Outcome Measure

Postoperative Drain output [ Time Frame: 48 hours ]

Central Contacts

• Jordan A Gruskay, MD
  2034647759
  [email protected]
• Evangelia Zgonia, BA
  2127742837
  [email protected]

Locations (1)

Find similar trials in New York, NY

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