Tranexamic Acid for Blood Loss Minimization in Endoscopic Pituitary Surgery

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04863339
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of North Carolina, Chapel Hill
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Brent Senior, MD
Principal Investigator Affiliation	UNC Chapel Hill
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pituitary Tumor, Blood Loss, Surgery

Arms & Interventions

Arms

Experimental: Tranexamic Acid

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

Placebo Comparator: Placebo

Patients in the placebo arm will receive a saline placebo.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UNC Chapel Hil, Chapel Hill, North Carolina

Status

Recruiting

Address

UNC Chapel Hil

Chapel Hill, North Carolina, 27514

Site Contact

Brent Senior, MD

[email protected]

919-966-3344