Tranexamic Acid for Blood Loss Minimization in Endoscopic Pituitary Surgery

NCT04863339 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: 20-2267
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Mean Blood Loss

  Blood loss measured in mL

  Time between incision and surgical closure, an average of 3 to 3.5 hours

Secondary Outcomes (1)

• Intra-operative Surgical Visibility - Wormald Scale Score

  Duration of operation, up to 4 hours

Other Outcomes (2)

• Incidence of Venous Thromboembolism

  from time of intervention administration through 1 week after surgery

• Mean Duration of Surgery

  Time between incision and surgical closure, an average of 3 to 3.5 hours

Study Arms (2)

Tranexamic Acid

EXPERIMENTAL

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

Drug: Tranexamic acid

Placebo

PLACEBO COMPARATOR

Patients in the placebo arm will receive a saline placebo.

Drug: Placebo

Interventions

Tranexamic acid DRUG

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

Tranexamic Acid

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing endoscopic pituitary surgery at UNC

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Related Publications (5)

• 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.

  PMID: 23477634 BACKGROUND

• 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.

  PMID: 31008946 BACKGROUND

• 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.

  PMID: 32224739 BACKGROUND

• 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.

  PMID: 25133491 BACKGROUND

• 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.

  PMID: 26554461 BACKGROUND

MeSH Terms

Conditions

Pituitary Neoplasms; Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Brent Senior, MD

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: April 28, 2021
• Study Start: March 1, 2022
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: April 5, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 12 to 24 months following publication
• 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.