Tranexamic Acid Dosing in Adult Spinal Deformity Surgery

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate two dosing protocols for tranexamic acid (TXA), an anti-fibrinolytic used to decrease blood loss in adult patients undergoing complex, reconstructive spinal fusion surgeries.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborator: AOSpine North America
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

• Adult patients (ages 18-75) scheduled to undergo long segment (greater than 8 motion segments) posterior spinal fusion with instrumentation (PSF) for adult scoliosis

Exclusion Criteria:

• Patients with acquired defective color vision

• Subarachnoid hemorrhage

• Active intravascular clotting

• Hypersensitivity to tranexamic acid or any of the ingredients

• Patients who pre-donate autologous blood for intra- or post-operative use (Directed donor units are acceptable)

• History of suspected blood disorders or abnormal coagulation laboratory results

• Current anticoagulation therapy that cannot be interrupted

• History of deep vein thrombosis (DVT)

• Impaired renal function or creatinine clearance <60 ml/min

• Pregnancy or women who are lactating/breastfeeding

• Women on hormonal contraceptives