Tranexamic Acid for Blood Loss Minimization in Endoscopic Pituitary Surgery

Tranexamic Acid for Blood Loss Minimization in Endoscopic Pituitary Surgery: A Double-Blind Randomized Controlled Trial

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.

Study Overview

• Status: Withdrawn
• Conditions: Surgery; Blood Loss; Pituitary Tumor
• Intervention / Treatment: Drug: Tranexamic acid; Drug: Placebo

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tranexamic Acid; Participants in the Tranexamic Acid arm will receive a dose of Tranexamic Acid.	Drug: Tranexamic acid; Single preoperative dose of 1 gram of Tranexamic Acid in 100 mL of saline given 0-30 minutes prior to surgery.
Placebo Comparator: Placebo; Patients in the placebo arm will receive a saline placebo.	Drug: Placebo; Single preoperative dose of 100 mL of saline placebo given 0-30 minutes prior to surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Blood Loss	Blood loss measured in mL	Time between incision and surgical closure, an average of 3 to 3.5 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra-operative Surgical Visibility - Wormald Scale Score	Wormald scale (0-10): The Wormald grading scale is a validated grading tool to measure visual field quality during endoscopic endonasal procedures. Lower scores indicate less bleeding and better surgical visibility. 0 = No bleeding (optimal); = 1-2 points of blood ooze; = 3-4 points of ooze; = 5-6 points of ooze; = 7-8 points of ooze; = 9-10 points of ooze; = >10 points of ooze, obscuring field; = Mild field bleeding with slow post-nasal accumulation; = Moderate field bleeding with moderate post-nasal accumulation; = Moderate-severe field bleeding with rapid post-nasal accumulation; = Severe bleeding (worst) with nose filling rapidly These measurements will take place 6 times. During hours 1, 2, 3, and 4 of the surgery, as well as during sphenoidotomy and durotomy.	Duration of operation, up to 4 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Venous Thromboembolism	Absolute number of incident venous thromboembolism	from time of intervention administration through 1 week after surgery
Mean Duration of Surgery	Measured in hours	Time between incision and surgical closure, an average of 3 to 3.5 hours

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Brent Senior, MD, UNC Chapel Hill

Publications and helpful links

General Publications

• Roberts I, Shakur H, Coats T, Hunt B, Balogun E, Barnetson L, Cook L, Kawahara T, Perel P, Prieto-Merino D, Ramos M, Cairns J, Guerriero C. The CRASH-2 trial: a randomised controlled trial and economic evaluation of the effects of tranexamic acid on death, vascular occlusive events and transfusion requirement in bleeding trauma patients. Health Technol Assess. 2013 Mar;17(10):1-79. doi: 10.3310/hta17100.
• Ping WD, Zhao QM, Sun HF, Lu HS, Li F. Role of tranexamic acid in nasal surgery: A systemic review and meta-analysis of randomized control trial. Medicine (Baltimore). 2019 Apr;98(16):e15202. doi: 10.1097/MD.0000000000015202.
• Heyns M, Knight P, Steve AK, Yeung JK. A Single Preoperative Dose of Tranexamic Acid Reduces Perioperative Blood Loss: A Meta-analysis. Ann Surg. 2021 Jan 1;273(1):75-81. doi: 10.1097/SLA.0000000000003793.
• Jahanshahi J, Hashemian F, Pazira S, Bakhshaei MH, Farahani F, Abasi R, Poorolajal J. Effect of topical tranexamic acid on bleeding and quality of surgical field during functional endoscopic sinus surgery in patients with chronic rhinosinusitis: a triple blind randomized clinical trial. PLoS One. 2014 Aug 18;9(8):e104477. doi: 10.1371/journal.pone.0104477. eCollection 2014.
• Mebel D, Akagami R, Flexman AM. Use of Tranexamic Acid Is Associated with Reduced Blood Product Transfusion in Complex Skull Base Neurosurgical Procedures: A Retrospective Cohort Study. Anesth Analg. 2016 Feb;122(2):503-8. doi: 10.1213/ANE.0000000000001065.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: April 23, 2021
• First Submitted That Met QC Criteria: April 23, 2021
• First Posted (Actual): April 28, 2021

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: March 25, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Hypothalamic Diseases; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Hemorrhage; Pituitary Neoplasms; Pituitary Diseases; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 20-2267

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Deidentified individual data that supports the results will be shared beginning 12 to 24 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
• IPD Sharing Time Frame: 12 to 24 months following publication
• IPD Sharing Access Criteria: Requests for IPD can be made by email and will be reviewed by the PI. The study protocol and deidentified data can be provided for scientific analyses performed by physicians and researchers affiliated with academic institutions.
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes