ACTH-Secreting Pituitary Adenoma
Conditions
Interventions
This is a prospective, comparative, double-blind longitudinal study with random distribution of the sample in blocks, through the website randomization.com, into two groups. Participants, a total of 4
20 will receive 20ml of tranexamic acid at 50mg/ml (Group A) and 20 will receive 20ml of 0.9% saline solution as a placebo (Group B). Once allocated to a given arm of the study, all will undergo the s
D26.660
Sponsors
Fundação de Beneficência Hospital de Cirurgia
Fundação de Beneficência Hospital de Cirurgia
Eligibility
Age
18 Years to No maximum
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Brazil
Contacts
Public ContactPaulo Eduardo Gonçalves
Universidade Federal de Sergipe
Outcome results
None listed