Tranexamic Acid for Blood Loss Minimization in Endoscopic Pituitary Surgery

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04863339
• Other study ID #: 20-2267
• Status: Withdrawn
• Phase: Phase 2
• Start date: March 2022
• Est. completion date: April 2022

Study information

• Verified date: March 2022
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss
• Hemorrhage
• Pituitary Diseases
• Pituitary Neoplasms
• Pituitary Tumor
• Surgery

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of Venous Thromboembolism	Absolute number of incident venous thromboembolism	from time of intervention administration through 1 week after surgery
Other	Mean Duration of Surgery	Measured in hours	Time between incision and surgical closure, an average of 3 to 3.5 hours
Primary	Mean Blood Loss	Blood loss measured in mL	Time between incision and surgical closure, an average of 3 to 3.5 hours
Secondary	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