Tranexamic Acid for Blood Loss Minimization in Endoscopic Pituitary Surgery

Study Overview
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Brief Summary
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This trial is to determine the effect of Tranexamic Acid (TXA) on blood loss during endoscopic pituitary surgery. The hypothesis of this study is that TXA will reduce blood loss during surgery compared to a placebo. To answer this hypothesis, the investigators are conducting a randomized controlled trial in which half of participants will receive TXA and half will receive placebo (saline) in a double blind fashion.

Official Title
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Tranexamic Acid for Blood Loss Minimization in Endoscopic Pituitary Surgery: A Double-Blind Randomized Controlled Trial

Conditions
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Pituitary Tumor, Blood Loss, Surgery

Intervention / Treatment
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* Drug: Tranexamic acid
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergoing endoscopic pituitary surgery at UNC Exclusion Criteria: Clival invasion Giant pituitary tumor (>4 cm) Revision pituitary surgery Prior sinus surgery Lund McKay score > 3 Active thromboembolic disease Coagulopathy Concomitant pro-thrombotic medications Concomitant use of anti-coagulants or anti-platelet agents Subarachnoid hemorrhage History of severe hypersensitivity to Tranexamic Acid

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants randomized to receive the investigational product vs placebo during a single study encounter.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic Acid<br>Participants in the Tranexamic Acid arm will receive a dose of Tranexamic Acid. | Drug: Tranexamic acid<br>* Single preoperative dose of 1 gram of Tranexamic Acid in 100 mL of saline given 0-30 minutes prior to surgery.<br>|
| Placebo Comparator: Placebo<br>Patients in the placebo arm will receive a saline placebo. | Drug: Placebo<br>* Single preoperative dose of 100 mL of saline placebo given 0-30 minutes prior to surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Blood Loss | Blood loss measured in mL | Time between incision and surgical closure, an average of 3 to 3.5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-operative Surgical Visibility - Wormald Scale Score | Wormald scale (0-10): The Wormald grading scale is a validated grading tool to measure visual field quality during endoscopic endonasal procedures. Lower scores indicate less bleeding and better surgical visibility. 0 = No bleeding (optimal) = 1-2 points of blood ooze = 3-4 points of ooze = 5-6 points of ooze = 7-8 points of ooze = 9-10 points of ooze = >10 points of ooze, obscuring field = Mild field bleeding with slow post-nasal accumulation = Moderate field bleeding with moderate post-nasal accumulation = Moderate-severe field bleeding with rapid post-nasal accumulation = Severe bleeding (worst) with nose filling rapidly These measurements will take place 6 times. During hours 1, 2, 3, and 4 of the surgery, as well as during sphenoidotomy and durotomy. | Duration of operation, up to 4 hours |