NCT04272606

TXA in Spinal Fusion

Prospective, Randomized, Double Blind Study on the Effects of Tranexamic Acid on Intraoperative Blood Loss During Lumbar Spinal Fusion And Instrumentation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Catherine R. Olinger · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Tranexamic acid and placebo will be given during surgery to patients who have elected to undergo lumber interbody fusion on 2 or more levels. Information regarding blood loss, transfusions needed, postoperative cognitive status (including delirium), postoperative markers of systemic inflammation and duration of hospital stay will be collected.

Detailed description

This study is to assess whether tranexamic acid (a drug that is used to coagulate the blood and reduce bleeding) use in lumbar spinal fusion can reduce blood loss and postoperative delirium compared to placebo. Thusly reducing need for transfusion, shorting the hospital stay and improving outcomes. For this the study will randomize patients who are receiving elective lumbar interbody fusion (PLIF or TLIF) of 2 or more levels for degenerative disc disease (DDD) into 2 groups. Group 1 would receive tranexamic acid during the surgery while group 2 will receive placebo. Blood loss during the surgery and postoperatively (while the patient has a drain) will be monitored along with the amount of transfusions needed, postoperative cognitive status (including delirium), postoperative markers of systemic inflammation, and and the duration of hospital stay. Delirium occurrence and severity will be assessed daily for the first 5 days after surgery or at discharge, whichever comes first. Cognitive status (neuropsychological tests) will be assessed at post-discharge follow up visits and compared to preoperative status. The drug or placebo are only given during the surgery. The patient population includes elective cases of patient undergoing lumbar spinal fusion of 2 or more levels. Spinal fusions are known to be associated with blood loss, especially when the surgeries are long and more levels need to be fused.

Conditions

• Degenerative Disc Disease

Interventions

Type	Name	Description
DRUG	Tranexamic Acid	Antifibrinolytic Agent
DRUG	Saline Solution	Placebo
DIAGNOSTIC_TEST	Visual Acuity Exam	Supplemented into standard of care daily neurological exam on day of surgery and day after
DIAGNOSTIC_TEST	3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)	3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.

Timeline

• Start date: 2020-08-01
• Primary completion: 2023-06-12
• Completion: 2023-06-12
• First posted: 2020-02-17
• Last updated: 2024-12-12
• Results posted: 2024-05-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study