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Intravenous Tranexamic Acid and Intraoperative Visualization During Functional Endoscopic Sinus Surgery

NCT01111669 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2012-04-27

No results posted yet for this study

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.

Conditions

  • Chronic Rhinosinusitis With Polyposis
  • Chronic Hyperplastic Sinusitis

Interventions

DRUG

Tranexamic Acid

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.

DRUG

Normal Saline (placebo)

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.

Sponsors & Collaborators

  • University of Alberta

    lead OTHER

Principal Investigators

  • Erin Wright, MD · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01111669 on ClinicalTrials.gov