Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Challenges in recruitment
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Blood Loss | — | UNRESOLVED | — |
| Pituitary Tumor | Pituitary Gland Neoplasm | ALIAS | 0.90 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Tranexamic acid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tranexamic Acid
- description
- Participants in the Tranexamic Acid arm will receive a dose of Tranexamic Acid.
- interventionNames
- Drug: Tranexamic acid
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Patients in the placebo arm will receive a saline placebo.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Mean Blood Loss
- timeFrame
- Time between incision and surgical closure, an average of 3 to 3.5 hours
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (5)
- BACKGROUNDRoberts 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
- BACKGROUNDPing 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
- BACKGROUNDHeyns 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
- BACKGROUNDJahanshahi 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
- BACKGROUNDMebel 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