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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01111669 |
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Date of registration:
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15/09/2009 |
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Primary sponsor: |
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Public title:
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Intravenous Tranexamic Acid and Intraoperative Visualization During Functional Endoscopic Sinus Surgery
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Scientific title:
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Intravenous Tranexamic Acid and Intraoperative Visualization During Functional Endoscopic Sinus Surgery: A Double Blind Randomized Controlled Trial |
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Date of first enrolment:
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August 2009 |
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Target sample size:
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28 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01111669 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Canada
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Contacts
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Name:
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Erin Wright, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Alberta |
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Key inclusion & exclusion criteria
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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
Age minimum:
17 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic Hyperplastic Sinusitis
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Chronic Rhinosinusitis With Polyposis
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Intervention(s)
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Drug: Normal Saline (placebo)
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Drug: Tranexamic Acid
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Primary Outcome(s)
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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)]
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Secondary Outcome(s)
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Completeness of the surgical procedure as affected by bleeding.
[Time Frame: Intraoperatively]
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Number and types of any complications or adverse events
[Time Frame: Peri-operative period]
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Perioperative Sinus Endoscopy (POSE) scoring system, a systematic visualization evaluation of the sinuses
[Time Frame: Intraoperatively]
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Surgical time.
[Time Frame: Intraoperatively]
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Total blood loss (monitoring of suctioned blood and monitoring of sponges and throat packs used during the operation)
[Time Frame: Intraoperatively]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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