- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01111669
Intravenous Tranexamic Acid and Intraoperative Visualization During Functional Endoscopic Sinus Surgery
Intravenous Tranexamic Acid and Intraoperative Visualization During Functional Endoscopic Sinus Surgery: A Double Blind Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alberta
-
Edmonton, Alberta, Canada, T6G 2B7
- University of Alberta Hospital, Royal Alexandra Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patients must be diagnosed with either:
- Chronic rhinosinusitis with polyposis (CRSwP) or
- 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:
- Hypertension (treated or untreated)
- Thrombotic diathesis
- Vascular disease, risk factors for vascular disease,
- Colorblindness
- Renal failure
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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 Names:
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
|
Intraoperatively (as infusion of tranexamic acid or placebo is being infused)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Perioperative Sinus Endoscopy (POSE) scoring system, a systematic visualization evaluation of the sinuses
Time Frame: Intraoperatively
|
Intraoperatively
|
Surgical time.
Time Frame: Intraoperatively
|
Intraoperatively
|
Total blood loss (monitoring of suctioned blood and monitoring of sponges and throat packs used during the operation)
Time Frame: Intraoperatively
|
Intraoperatively
|
Completeness of the surgical procedure as affected by bleeding.
Time Frame: Intraoperatively
|
Intraoperatively
|
Number and types of any complications or adverse events
Time Frame: Peri-operative period
|
Peri-operative period
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Erin Wright, MD, University of Alberta
Publications and helpful links
General Publications
- Ho KM, Ismail H. Use of intravenous tranexamic acid to reduce allogeneic blood transfusion in total hip and knee arthroplasty: a meta-analysis. Anaesth Intensive Care. 2003 Oct;31(5):529-37. doi: 10.1177/0310057X0303100507.
- Henry DA, Carless PA, Moxey AJ, O'Connell D, Stokes BJ, McClelland B, Laupacis A, Fergusson D. Anti-fibrinolytic use for minimising perioperative allogeneic blood transfusion. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD001886. doi: 10.1002/14651858.CD001886.pub2.
- Snir M, Axer-Siegel R, Buckman G, Yassur Y. Central venous stasis retinopathy following the use of tranexamic acid. Retina. 1990;10(3):181-4.
- Kitamura H, Matsui I, Itoh N, Fujii T, Aizawa M, Yamamoto R, Okuno A, Okazaki Y, Fujita Y, Kuwayama Y, Imai E, Fujii M. Tranexamic acid-induced visual impairment in a hemodialysis patient. Clin Exp Nephrol. 2003 Dec;7(4):311-4. doi: 10.1007/s10157-003-0254-y.
- Kavanagh GM, Sansom JE, Harrison P, Warwick JA, Peachey RD. Tranexamic acid (Cyklokapron)-induced fixed-drug eruption. Br J Dermatol. 1993 Feb;128(2):229-30. doi: 10.1111/j.1365-2133.1993.tb15161.x. No abstract available.
- Carrion-Carrion C, del Pozo-Losada J, Gutierrez-Ramos R, de Lucas-Laguna R, Garcia-Diaz B, Casado-Jimenez M, Esperanza-Jimenez Caballero ME. Bullous eruption induced by tranexamic acid. Ann Pharmacother. 1994 Nov;28(11):1305-6. doi: 10.1177/106002809402801121. No abstract available.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200901
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Rhinosinusitis With Polyposis
-
Fondation Ophtalmologique Adolphe de RothschildCompletedChronic Rhinosinusitis With Nasal Polyposis (CRSwNP)
-
Keymed Biosciences Co.LtdNot yet recruitingChronic Rhinosinusitis With Nasal Polyposis
-
Regeneron PharmaceuticalsSanofiRecruitingChronic Rhinosinusitis With Nasal PolyposisUnited States, Italy, Canada, Japan, Germany, Netherlands
-
Beijing Tongren HospitalCompletedChronic Rhinosinusitis With Polyposis
-
Christiane HaaseActive, not recruitingAsthma | Chronic Rhinosinusitis (Diagnosis) | Chronic Rhinosinusitis With Nasal Polyps | Chronic Rhinosinusitis Without Nasal PolypsDenmark
-
Johns Hopkins UniversityGlaxoSmithKlineRecruitingChronic Rhinosinusitis (Diagnosis) | Chronic Rhinosinusitis With Nasal PolypsUnited States
-
Ohio State UniversityActive, not recruitingChronic Rhinosinusitis With Nasal Polyps | Chronic Rhinosinusitis Without Nasal PolypsUnited States
-
Medical University of ViennaRecruitingAsthma | Chronic Rhinosinusitis (Diagnosis) | Nasal Polyps | Chronic Rhinosinusitis With Nasal PolypsAustria
-
St. Paul's Sinus CentreRecruitingAsthma | Chronic Rhinosinusitis With Nasal Polyps | Chronic Rhinosinusitis Without Nasal PolypsCanada
-
University of California, San FranciscoNational Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health...RecruitingAsthma | Chronic Rhinosinusitis (Diagnosis) | Chronic Rhinosinusitis With Nasal PolypsUnited States
Clinical Trials on Tranexamic Acid
-
Icahn School of Medicine at Mount SinaiRecruiting
-
University of LiegeCompletedArthroplasty Complications | Hemorrhage Postoperative | Total Blood LossBelgium
-
London School of Hygiene and Tropical MedicineCompleted
-
Samsung Medical CenterUnknownBleeding | Transfusion Related ComplicationKorea, Republic of
-
Ain Shams UniversityCompleted
-
Aswan University HospitalCompletedCesarean Section ComplicationsEgypt
-
Assiut UniversityCompleted
-
London School of Hygiene and Tropical MedicineRawalpindi Medical CollegeCompletedPregnancy, High RiskPakistan, Zambia
-
Thammasat UniversityCompleted
-
Ferring PharmaceuticalsCompleted