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Tranexamic Acid for Blood Loss Minimization in Endoscopic Pituitary Surgery

NCT04863339 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-04-05

No results posted yet for this study

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.

Conditions

  • Pituitary Tumor
  • Blood Loss
  • Surgery

Interventions

DRUG

Tranexamic acid

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

DRUG

Placebo

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

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Brent Senior, MD · UNC Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-31
Primary Completion
2022-04-30
Completion
2022-04-30
FDA Drug
Yes

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04863339 on ClinicalTrials.gov