Tranexamic Acid for Blood Loss Minimization in Endoscopic Pituitary Surgery

Phase 2

Withdrawn

• Conditions: Blood Loss; Surgery; Pituitary Tumor
• Interventions: Drug: Tranexamic acid; Drug: Placebo

• Registration Number: NCT04863339
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-23
• Study First Submitted QC: 2021-04-23
• Study First Posted: 2021-04-28
• Status Verified: 2022-03
• Study Start: 2022-03
• Last Update Submitted: 2022-03-25
• Primary Completion: 2022-04
• Study Completion: 2022-04
• Last Update Posted: 2022-04-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic Acid	Tranexamic acid	Participants in the Tranexamic Acid arm will receive a dose of Tranexamic Acid.
Placebo	Placebo	Patients in the placebo arm will receive a saline placebo.

Primary Outcome Measures

Name	Time	Method
Mean Blood Loss	Time between incision and surgical closure, an average of 3 to 3.5 hours	Blood loss measured in mL

Secondary Outcome Measures

Name	Time	Method
Intra-operative Surgical Visibility - Wormald Scale Score	Duration of operation, up to 4 hours	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. = 1-2 points of blood ooze; 2. = 3-4 points of ooze; 3. = 5-6 points of ooze; 4. = 7-8 points of ooze; 5. = 9-10 points of ooze; 6. = \>10 points of ooze, obscuring field; 7. = Mild field bleeding with slow post-nasal accumulation; 8. = Moderate field bleeding with moderate post-nasal accumulation; 9. = Moderate-severe field bleeding with rapid post-nasal accumulation; 10. = 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.