Intravenous Tranexamic Acid and Intraoperative Visualization During Functional Endoscopic Sinus Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Morgan Langille, University of Alberta
ClinicalTrials.gov Identifier:
NCT01111669
First received: September 15, 2009
Last updated: April 25, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Chronic Rhinosinusitis With Polyposis
Chronic Hyperplastic Sinusitis
Drug: Tranexamic Acid
Drug: Normal Saline (placebo)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intravenous Tranexamic Acid and Intraoperative Visualization During Functional Endoscopic Sinus Surgery: A Double Blind Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • The Wormald grading scale, this is a validated instrument used to assess intraoperative bleeding during video endoscopy sinus surgery. [ Time Frame: Intraoperatively (as infusion of tranexamic acid or placebo is being infused) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Perioperative Sinus Endoscopy (POSE) scoring system, a systematic visualization evaluation of the sinuses [ Time Frame: Intraoperatively ] [ Designated as safety issue: No ]
  • Surgical time. [ Time Frame: Intraoperatively ] [ Designated as safety issue: No ]
  • Total blood loss (monitoring of suctioned blood and monitoring of sponges and throat packs used during the operation) [ Time Frame: Intraoperatively ] [ Designated as safety issue: No ]
  • Completeness of the surgical procedure as affected by bleeding. [ Time Frame: Intraoperatively ] [ Designated as safety issue: No ]
  • Number and types of any complications or adverse events [ Time Frame: Peri-operative period ] [ Designated as safety issue: Yes ]

Enrollment: 28
Study Start Date: August 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tranexamic Acid
Patients in the tranexamic acid (TA) group will receive a bolus of TA, prepared according to patient weight (15mg / kg loading dose). The patients would also receive a continuous infusion of 1mg / kg per hour or TA preparation for the duration of the operation.
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.
Other Name: cyklokapron
Placebo Comparator: Normal Saline
The patients receiving placebo will receive an infusion of normal saline of the same volume of IV solution as the intervention group. 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 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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Patients must be diagnosed with either:

  1. Chronic rhinosinusitis with polyposis (CRSwP) or
  2. Chronic hyperplastic sinusitis. Patients must have an ASA classification of I or II and must be undergoing bilateral FESS as treatment for one of the above diagnoses.

Exclusion Criteria:

  1. Hypertension (treated or untreated)
  2. Thrombotic diathesis
  3. Vascular disease, risk factors for vascular disease,
  4. Colorblindness
  5. Renal failure
  6. Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01111669

Locations
Canada, Alberta
University of Alberta Hospital, Royal Alexandra Hospital
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Erin Wright, MD University of Alberta
  More Information

Publications:
Responsible Party: Morgan Langille, MD, University of Alberta
ClinicalTrials.gov Identifier: NCT01111669     History of Changes
Other Study ID Numbers: 200901
Study First Received: September 15, 2009
Last Updated: April 25, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of Alberta:
Functional Endoscopic Sinus Surgery
Tranexamic Acid

Additional relevant MeSH terms:
Hyperplasia
Pathologic Processes
Tranexamic Acid
Antifibrinolytic Agents
Coagulants
Fibrin Modulating Agents
Hematologic Agents
Hemostatics
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014