At a glance
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Intravenous Tranexamic Acid and Intraoperative Visualization During Functional Endoscopic Sinus Surgery: A Double Blind Randomized Controlled Trial
In Brief
A clinical study evaluating Tranexamic Acid and Normal Saline (placebo) for Chronic Rhinosinusitis With Polyposis and Chronic Hyperplastic Sinusitis. Completed, enrolled 28 participants across 1 site.
Detailed Summary
Functional endoscopic sinus surgery (FESS) is an effective treatment of sinus disease. FESS is carried out using cameras to view the surgical field. Bleeding during the surgery can lead to poor surgical field visualization. Poor visualization has been associated with worse surgical outcomes. Tranexamic acid is a safe and effective agent used to achieve hemostasis during operative procedures. The current study is a randomized controlled trial in patients undergoing FESS to compare the effects of tranexamic acid versus placebo and the effects on surgical field visualization and adverse events.
Study Details
Timeline
Interventions
The bolus of TA is prepared according to patient weight (10mg / kg loading dose). The patients receiving placebo will receive an infusion of normal saline of the same volume of IV solution. Patients will receive the TA or saline infusion on call to the operating room, approximately 30 minutes before onset of the operation. The patients would also receive a continuous infusion of 1mg / kg per hour or TA preparation or normal saline for the duration of the operation.
The patients receiving placebo will receive an infusion of normal saline of the same volume of IV solution. Patients will receive the saline infusion on call to the operating room, approximately 30 minutes before onset of the operation. The patients would also receive a continuous infusion of saline for the duration of the operation.