Clinical trial NCT04863339: Tranexamic Acid for Blood Loss Minimization in Endoscopic Pituitary Surgery
Official title: Tranexamic Acid for Blood Loss Minimization in Endoscopic Pituitary Surgery: A Double-Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Pituitary Tumor
Blood Loss
Surgery
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2021-04-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants randomized to receive the investigational product vs placebo during a single study encounter.
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Mean Blood Loss
timeFrame: Time between incision and surgical closure, an average of 3 to 3.5 hours
Secondary outcomes:
measure: Intra-operative Surgical Visibility - Wormald Scale Score
timeFrame: Duration of operation, up to 4 hours
Other outcomes:
measure: Incidence of Venous Thromboembolism
timeFrame: from time of intervention administration through 1 week after surgery
measure: Mean Duration of Surgery
timeFrame: Time between incision and surgical closure, an average of 3 to 3.5 hours
Locations:
Study officials:
affiliation: UNC Chapel Hill
name: Brent Senior, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.
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.