An Early Phase 1 interventional study of Tranexamic Acid (TXA) and Tranexamic Acid in Blood Loss, Surgical, sponsored by Assiut University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-29.
Sponsored by Assiut University · Early Phase 1, Interventional, and Health services research
The aim of this study is to investigate the effect of preoperative administration of intravenous or nebulized tranexamic acid on surgical field, blood loss, anesthetic consumption and hemodynamics of patients undergoing FESS.
Primary outcome Modena Bleeding Score (MBS) assessing surgical field Secondary outcome
Functional endoscopic sinus surgery (FESS) is the current standard treatment for a variety of conditions affecting the nasal cavity and the paranasal sinuses, such as chronic rhinosinusitis, benign and malignant tumors or cerebrospinal fluid leaks .Being mostly a one-handed technique, FESS does not allow simultaneous use of operative instruments and blood suction, thus endonasal bleeding control represents a challenging issue for the operating surgeon. Such narrow and highly vascularized cavities like the nasal fossae and paranasal spaces can be entirely filled with blood within few seconds, especially if the mucosa is severely inflamed as a consequence of rhinosinusitis. Bleeding is possibly the most relevant factor that could impair the quality of the surgical field during endoscopic procedures. It has been proven that uncontrolled bleeding during endoscopic sinus surgical procedures determines poor visualization of the anatomical landmarks, prolongs surgical time and carries a higher rate of complications .Several techniques to control intraoperative bleeding and improve surgical view during sinus surgery (e.g. topical vasoconstrictors, total intravenous anesthesia, controlled hypotension) have been described and analyzed to determine their efficacy .These types of studies, however, are complex and prone to bias, partially because standardized and validated methods of quantifying bleeding or grading the surgical field in endoscopic view are lacking.
Tranexamic acid functions as the competitive antagonist at the lysine site on plasminogen . During all surgical procedures, the tissue plasminogen activator is released due to tissue damage during surgery, which can convert tissue plasminogen to plasmin, promote fibrinolysis and activate the fibrinolytic system. Thus, tranexamic acid functions as an anti-fibrinolytic agent by inhibiting the tissue plasminogen activator. It can be applied topically or systemically with this mechanism in the coagulation cascade to reduce intraoperative bleeding .The results of several recent studies on endoscopic sinus surgery through topical administration of tranexamic acid are encouraging in terms of the efficacy of tranexamic acid for intraoperative bleeding and other pathological conditions .The purpose of this study is to analyze the efficacy of nebulized tranexamic acid and compare it with intravenous tranexamic acid to improve the surgeon and patient experiences of sinus surgery.
Exclusion Criteria:
chronic renal failure
Drug: Tranexamic Acid
Drug: Tranexamic Acid (TXA)
To see if nebulised TXA is better to control blood loss in functional Endoscopic sinus surgery
To see if intravenous TXA is better to control blood loss in functional Endoscopic sinus surgery
Modena Bleeding Score- assessing surgical field
* No bleeding -\>1. * Bleeding easily controlled by suctioning, washing, or packing without any significant modification or slowing of surgical procedure-\>2. * Bleeding slowing surgical procedure-\>3. * Most of the maneuvers dedicated to bleeding control -\>4. * Bleeding that prevents every surgical procedure except those dedicated to bleeding control-\>5.
Time frame: Baseline
Measuring patient's Blood Pressure-> mmhg (unit of measure)
Time frame: Baseline
Measuring patient's Respiratory Rate-> breath per minute(unit of measure)
Time frame: Baseline
Measuring patient's Temperature-> Celsius(unit of measure)
Time frame: Baseline
Measuring patient's Pulse->Beat per minute(unit of measure)
Time frame: Baseline
Measuring End-tidal Co2 by Capnogram
Unit of measure-\> mmhg
Time frame: Baseline
Measuring O2 saturation by the pulse-oximeter
Time frame: Baseline
Measuring amount of intraoperative bleeding through blood volume in suction jar
Time frame: Baseline
Measuring the amount of intraoperative bleeding by counting gauze used in the operation.
Time frame: Baseline
2. Anesthetic consumption, Extra doses of fentanyl and propofol and sevoflurane>2
Time frame: Baseline
Presence or absence of nausea as a Postoperative complication
Time frame: Baseline
Presence or absence of vomiting as a Postoperative complication
Time frame: Baseline
Presence or absence of any form of visual disturbance as a Postoperative complication
Time frame: Baseline
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Assiut University