Tranexamic Acid evaluation in nasal surgery to remove pituitary tumors: a randomized double-blind study

Not Applicable

Recruiting

• Conditions: Prolactinoma; Nasal Surgical Procedures; ACTH-Secreting Pituitary Adenoma; Growth Hormone-Secreting Pituitary Adenoma; Natural Orifice Endoscopic Surgery; C04.588.322.609

• Registration Number: RBR-4kqbbnp
• Lead Sponsor: Fundação de Beneficência Hospital de Cirurgia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-03-21
• Last Update Posted: 2 April 2024
• Study Completion: 2024-07-10

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Volunteers over 18 years old; both genders; nuclear magnetic resonance imaging of the skull showing alterations compatible with pituitary adenomas and pathology confirming pituitary adenoma

Exclusion Criteria

Volunteers who will not undergo endoscopic endonasal surgery; patients with hematological disorders; patients with a different anatomopathological diagnosis of pituitary adenoma in the postoperative period; patients with recurrent pituitary tumors and who received a blood transfusion during surgery.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
It is expected to find a decrease in the volume of blood lost during surgery with the use of tranexamic acid, verified through the direct measurement of the volume of fluid in the suction container, by the Gross equation for estimated blood loss both in red blood cell volume and blood total, for estimated formula of blood loss through calculation using the patient's hemoglobin value and the aspiration liquid; to verify that there really was a reduction, any variation below the mean of the control group will be accepted as a positive result as long as it has statistical significance, based on a previous study, it is expected that this difference is above 100ml. ;It is expected to find a decrease in surgical time, verified by the total surgery time recorded by a common clock, any value below the mean of the control group will be accepted as positive, provided that it has statistical significance.

Secondary Outcome Measures

Name	Time	Method
Evaluate adverse events from the use of tranexamic acid, in 24h of follow-up; it is expected to find a low occurrence of side effects, verified through a questionnaire applied to volunteer patients, this one elaborated based on the side effects described in the leaflet.