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Tranexamic Acid to Reduce Blood Loss in Spine Surgery

ConditionsSpinal InjuriesSpinal Deformity
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorColumbia University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

252 Participants
are divided into 2 treatment groups
Group A: InterventionActive comparator 1 intervention
Group B: Placebo controlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Maximal drop in systemic hemoglobin concentration during the postoperative period

Time frame
Patients will be followed through postoperative day 4

Secondary outcomes

1

Reduction in the rate of surgical site infections

Defined by decreasing the allogenic transfusion rate (an independent risk factor for surgical site infections) as well as by decreasing the formation of postoperative hematoma (a nidus for infection).

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

Number of complications

Defined as thromboembolic event, including deep vein thrombosis (DVT) or pulmonary embolism (PE)

Time frame
Up to postoperative day 4
3

Systemic absorption of locally applied drug

Time frame
Baseline (pre-surgery), immediately after administration of the topical agent, 1 hour after administration
4

Patient assessed health-related quality of life score

This will be determined by a questionnaire/score

Time frame
Up to 2 years postoperation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Columbia University

Lead sponsor

United States Department of Defense

Collaborator

Source ClinicalTrials.gov
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