Chronic Rhinosinusitis With Polyposis Clinical Trial
Official title:
Intravenous Tranexamic Acid and Intraoperative Visualization During Functional Endoscopic Sinus Surgery: A Double Blind Randomized Controlled Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03687515 -
Efficacy and Safety of Budesonide Inhalation Suspension for the Treatment of Chronic Rhinosinusitis With Polyposis.
|
Phase 3 |