NCT04312880

Tranexamic Acid Infusion During Elective Spine Surgery

• Status: Enrolling By Invitation
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: Albany Medical College · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Tranexamic acid (TXA) is an agent that has been shown to be safe and effective to reduce blood loss in surgical procedures. The purpose of the study is to assess the effect of transexamic on elective decompressive lumbar spine surgery with and without fusion.

Detailed description

This will be a prospective randomized control, double-blinded investigation. The Investigators will recruit patients undergoing elective, primary, decompressive lumbar surgery via a posterior surgical approach of less than 3 levels. This includes patients undergoing decompressive lumbar laminectomies with or without fusion. Fusion may include posterior interbody and/or posterior lateral techniques with instrumentation. There will be 3 treatment arms with the goal of 65 patients in each arm. Patients will be randomized pre-operatively and enrolled into the IV transexamic acid group (receiving intraoperative intravenous tranexamic acid infusion), or the topical transexamic acid group or the control/placebo group (receiving intraoperative intravenous saline). The Investigators expect the duration of each treatment group to be approximately 4-5 months. Therefore, the study should be completed within 1.5 years. The primary surgeon and anesthesia staff will not be blinded to the treatment arm due to the nature of the different administration routes, but post-operative nursing staff will be blinded to administration routes.

Conditions

• Spine Surgery

Interventions

Type	Name	Description
DRUG	Tranexamic Acid	IV and topical form of TXA will be administered to patients in the respective groups.

Timeline

• Start date: 2018-12-01
• Primary completion: 2021-01-01
• Completion: 2021-01-01
• First posted: 2020-03-18
• Last updated: 2020-08-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study