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Intravenous Tranexamic Acid and Intraoperative Visualization During Functional Endoscopic Sinus Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01111669
Recruitment Status : Completed
First Posted : April 27, 2010
Last Update Posted : April 27, 2012
Sponsor:
Information provided by (Responsible Party):
Morgan Langille, University of Alberta

Tracking Information
First Submitted Date  ICMJE September 15, 2009
First Posted Date  ICMJE April 27, 2010
Last Update Posted Date April 27, 2012
Study Start Date  ICMJE August 2009
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2010)
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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2011)
  • Perioperative Sinus Endoscopy (POSE) scoring system, a systematic visualization evaluation of the sinuses [ Time Frame: Intraoperatively ]
  • Surgical time. [ Time Frame: Intraoperatively ]
  • Total blood loss (monitoring of suctioned blood and monitoring of sponges and throat packs used during the operation) [ Time Frame: Intraoperatively ]
  • Completeness of the surgical procedure as affected by bleeding. [ Time Frame: Intraoperatively ]
  • Number and types of any complications or adverse events [ Time Frame: Peri-operative period ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2010)
  • Perioperative Sinus Endoscopy (POSE) scoring system, a systematic visualization evaluation of the sinuses [ Time Frame: Intraoperatively ]
  • Surgical time. [ Time Frame: Intraoperatively ]
  • Total blood loss (monitoring of suctioned blood and monitoring of sponges and throat packs used during the operation) [ Time Frame: Intraoperatively ]
  • Completeness of the surgical procedure as affected by bleeding. [ Time Frame: Intraoperatively ]
  • Number and types of complications and adverse events [ Time Frame: Peri-operative period ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intravenous Tranexamic Acid and Intraoperative Visualization During Functional Endoscopic Sinus Surgery
Official Title  ICMJE Intravenous Tranexamic Acid and Intraoperative Visualization During Functional Endoscopic Sinus Surgery: A Double Blind Randomized Controlled Trial
Brief 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.
Detailed Description

Study Objectives: The current study will assess the effect of tranexamic acid on intraoperative bleeding and surgical outcomes during functional endoscopic sinus surgery.

Background: Tranexamic acid is an antifibrinolytic that prevents the activation of plasminogen to plasmin. Plasmin is responsible for the degradation of fibrin clots. This is the mechanism by which tranexamic acid prevents blood clot breakdown and reduces operative bleeding. Functional endoscopic sinus surgery, or FESS, is a widely used surgical technique to treat sinusitis and other diseases of the nose and nasal cavities. Bleeding during FESS can hinder surgical progress and has been associated with an increase in complications.

Methods: The current study is randomized, double-blind and placebo- controlled. Study sample size will be calculated based on a previous study of topical intranasal TA. Participants undergoing functional endoscopic sinus surgery will be recruited for the study during a preoperative outpatient clinic visit. Each participant will be randomized to a group receiving either tranexamic acid or normal saline bolus immediately prior to the operation. Inclusion criteria for the study are as follows: 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 include patients with hypertension (treated or untreated), thrombotic diathesis, vascular disease, risk factors for vascular disease, colorblindness, renal failure, and those who may be pregnant. These exclusion criteria are based on the potential risks of using tranexamic acid in these patients (see safety data information section below). The exclusion criteria for hypertension will include anyone who has been diagnosed previously with hypertension or has been on anti-hypertensive medications for this diagnosis. The hypertensive patients will be excluded due to the difficulties maintaining standardized anesthesia protocol (such as mean arterial pressure) in these patients. The authors of the current study will not be testing for pregnancy. Patients will be asked the date of their last menstrual period as per the standard pre-operative questionnaire, any patients who may be pregnant would not only be excluded from the trial but would not undergo a general anesthetic for an elective procedure due to the risk of preterm labour. The diagnosis of renal failure will be determined by patient history, the current study will not require systematic lab diagnosis to calculate renal function. The study will keep a record of the surgeon(s) and residents present during surgery to evaluate potential differences during the data analysis. The study will blind both the surgeon(s) and anesthesiologist as to what each patient received. The day before a scheduled operation of a patient enrolled in the study, the pharmacy will determine if the patient is to receive TA or placebo based on the randomization table. The bolus of TA is prepared according to patient weight (15mg/kg loading dose). The patients receiving placebo will receive an infusion of normal saline of the same volume. 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 current study will use a standardized anesthesia protocol using universally accepted parameters. The operation will be carried out using primarily inhalational anesthetic. End- tidal CO2 will be maintained between the target ranges of 30-35 mmHg. The head of the bed will be elevated to 15 degrees. The target range for the mean arterial pressure will be 60-70 mmHg.

Outcome Measures: The outcome measures for the current study are as follows: 1. The Wormald grading scale, this is a validated instrument used to assess intraoperative bleeding during video endoscopy sinus surgery. Dr. Wright will apply the Wormald grading scale intraoperatively. 2. Perioperative Sinus Endoscopy (POSE) scoring system, a systematic visualization evaluation of the sinuses. 3. Lund- Kennedy endoscopic reporting system, a validated staging system for sinus disease. 4. Lund- MacKay CT score, used for radiologic evaluation of sinus disease, 5. Number of sinuses and which sinuses were involved in the operative procedure. 6. Surgical time. 7. Total blood loss (monitoring of suctioned blood and monitoring of sponges and throat packs used during the operation. 8. Completeness of the surgical procedure as affected by bleeding.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Rhinosinusitis With Polyposis
  • Chronic Hyperplastic Sinusitis
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Tranexamic Acid
  • 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.
    Intervention: Drug: Normal Saline (placebo)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 25, 2012)
28
Original Estimated Enrollment  ICMJE
 (submitted: April 26, 2010)
27
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 17 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01111669
Other Study ID Numbers  ICMJE 200901
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Morgan Langille, University of Alberta
Study Sponsor  ICMJE University of Alberta
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Erin Wright, MD University of Alberta
PRS Account University of Alberta
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP