Tranexamic Acid for Blood Loss Minimization in Endoscopic Pituitary Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-31

Study Completion Date

2022-04-30

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.

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Detailed Description

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Conditions

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Pituitary Tumor Blood Loss Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants randomized to receive the investigational product vs placebo during a single study encounter.

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The only staff with access to randomization codes will be our study statistician who created the randomization table and our investigational drug services pharmacy who is preparing the investigational product.

Study Groups

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Tranexamic Acid

Participants in the Tranexamic Acid arm will receive a dose of Tranexamic Acid.

Group Type EXPERIMENTAL

Tranexamic acid

Intervention Type DRUG

Single preoperative dose of 1 gram of Tranexamic Acid in 100 mL of saline given 0-30 minutes prior to surgery.

Placebo

Patients in the placebo arm will receive a saline placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single preoperative dose of 100 mL of saline placebo given 0-30 minutes prior to surgery.

Interventions

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Tranexamic acid

Single preoperative dose of 1 gram of Tranexamic Acid in 100 mL of saline given 0-30 minutes prior to surgery.

Intervention Type DRUG

Placebo

Single preoperative dose of 100 mL of saline placebo given 0-30 minutes prior to surgery.

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes