Tranexamic Acid to Reduce Blood Loss in Spine Surgery

NCT02314988 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: AAAQ6795201409111
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 4

Brief Summary

This study is designed to evaluate the efficacy of topical tranexamic acid to reduce perioperative blood loss, reduction in postoperative drain output and allogenic transfusion requirements. The proposed study will be a prospective, randomized, double-blind (subject, surgeons, investigators, research coordinators) placebo-controlled study. Patients requiring posterior spinal fusion will be enrolled for this study. Furthermore, patients undergoing elective complex deformity surgery will also be enrolled. Both populations of patients will be randomized into two groups. Group I will receive standard of care operative fixation with topical tranexamic acid intervention (test); Group II will receive standard of care operative fixation with normal saline (placebo) intervention. This study will have a 2-year follow-up and will consist of three periods: screening/enrollment phase up to 21 days from the day of injury to the day of randomization and operative intervention, an inpatient data collection period for 4 days postoperative, and then a follow-up period for 2-years postoperative (visits occurring at 16 weeks, 1 year, and 2 year) time points.

Conditions

Spinal Injuries; Spinal Deformity

Keywords

Tranexamic acid; Antifibrinolytic; Perioperative blood loss; Postoperative drain output; Allogenic transfusion

Outcome Measures

Primary Outcomes (1)

• Maximal drop in systemic hemoglobin concentration during the postoperative period

  Patients will be followed through postoperative day 4

Secondary Outcomes (5)

• Reduction in the rate of surgical site infections

  Duration of the hospital stay (an average of 2 weeks), first postoperative wound check visit

• Number of complications

  Up to postoperative day 4

• Systemic absorption of locally applied drug

  Baseline (pre-surgery), immediately after administration of the topical agent, 1 hour after administration

• Patient assessed health-related quality of life score

  Up to 2 years postoperation

• Difference in costs for hospital stay between using tranexamic acid and placebo

  Duration of the hospital stay (an average of 2 weeks)

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Subjects will receive tranexamic acid on the surgical wound.

Drug: Tranexamic Acid

Placebo control

PLACEBO COMPARATOR

Subjects will receive placebo (saline solution) on the surgical wound.

Drug: Placebo

Interventions

Tranexamic Acid DRUG

3.0 grams of tranexamic acid will be poured in the surgical field and left in contact for five minutes. Subsequently, excess study solution will be suctioned away without touching the surrounding tissue surfaces and then the would closed without irrigation or manipulation. TXA solution will be prepared using a dose of 3 grams of tranexamic acid combined with 70 mL of sterile normal saline, for a total volume of 100 mL.

Also known as: Cyclokapron, TXA

Intervention

Placebo DRUG

Placebo will be poured in the surgical field and left in contact for five minutes. Subsequently, excess solution will be suctioned away without touching the surrounding tissue surfaces and then the would closed without irrigation or manipulation. The placebo solution will be 100 mL of sterile normal saline.

Also known as: Saline Solution

Placebo control

Eligibility Criteria

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

You may qualify if:

• Thoracic or lumbar spinal column injury with or without neurologic deficit requiring surgical fixation
• Surgical fixation to be performed within 21 days of injury
• Adult patients undergoing long segment (\>5 fusion levels) posterior spinal fusions

You may not qualify if:

• Age \<18 or \>80 years old
• Severe soft tissue disruption around planned surgical site preventing adequate primary wound closure
• Physiologic instability or ongoing sepsis/infection
• Use of intravenous tranexamic acid during the pre-study period
• Ballistic spinal column injury
• Allergy to tranexamic acid
• Disturbances of color vision or color blindness
• Pre-operative hemoglobin value of \<7 g/dL, or \<10 g/dL if patient has comorbidities or symptoms which will require pre-operative allogeneic blood transfusion
• Refusal to consent for blood products
• Participation in another clinical trial
• Moderate or severe traumatic brain injuries that do not allow participation in individual patient outcomes surveys
• Subarachnoid hemorrhage, anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by TXA
• Concomitant use of Factor IX Complex concentrates or Anti-inhibitor Coagulant concentrates, as the risk of thrombosis may be increased
• Preoperative use of anticoagulant therapy (heparin, low-molecular weight heparin, warfarin) within three days before surgery, or non-steroid inflammatory medication (aspirin, ibuprofen, naprosyn) use within seven days before surgery
• Fibrinolytic disorders requiring intraoperative antifibrinolytic treatment

Sponsors & Collaborators

• Columbia University: lead
• United States Department of Defense: collaborator

Study Sites (4)

University of California San Francisco Medical Center

San Francisco, California, 94149, United States

RECRUITING

Norton Leatherman Spine Center

Louisville, Kentucky, 40202, United States

RECRUITING

NYP/The Allen Hospital - CUIMC

New York, New York, 10032, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Conditions

Spinal Injuries

Interventions

Tranexamic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Back Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ronald A Lehman, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ronald A Lehman, MD

CONTACT

2129325067; rl2781@cumc.columbia.edu

Matthew J. Cooney

CONTACT

mc5386@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Orthopaedic Surgery

Study Record Dates

• First Submitted: December 3, 2014
• First Posted: December 11, 2014
• Study Start: June 15, 2020
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

US (4)