Tranexamic Acid for Blood Loss Minimization in Endoscopic Pituitary Surgery

University of North Carolina (UNC)

Status and phase: Withdrawn; Phase 2

Conditions: Surgery; Blood Loss; Pituitary Tumor

Treatments: Drug: Tranexamic acid; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04863339

20-2267

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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 design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Tranexamic Acid

Experimental group

Description:

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

Treatment:

Drug: Tranexamic acid

Placebo

Placebo Comparator group

Description:

Patients in the placebo arm will receive a saline placebo.

Treatment:

Drug: Placebo