drugset / Trial / NCT01111669
Intravenous Tranexamic Acid and Intraoperative Visualization During Functional Endoscopic Sinus Surgery
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Functional endoscopic sinus surgery (FESS) is an effective treatment of sinus disease. FESS is carried out using cameras to view the surgical field. Bleeding during the surgery can lead to poor surgical field visualization. Poor visualization has been associated with worse surgical outcomes. Tranexamic acid is a safe and effective agent used to achieve hemostasis during operative procedures. The current study is a randomized controlled trial in patients undergoing FESS to compare the effects of tranexamic acid versus placebo and the effects on surgical field visualization and adverse events.
Timeline
- Start
- 2009-08
- Primary completion
- 2011-12
- Completion
- 2011-12
Publications
- Background Henry DA, Carless PA, Moxey AJ, O'Connell D, Stokes BJ, McClelland B, Laupacis A, Fergusson D. Anti-fibrinolytic use for minimising perioperative allogeneic blood transfusion. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD001886. doi: 10.1002/14651858.CD001886.pub2.
- Background Ho KM, Ismail H. Use of intravenous tranexamic acid to reduce allogeneic blood transfusion in total hip and knee arthroplasty: a meta-analysis. Anaesth Intensive Care. 2003 Oct;31(5):529-37. doi: 10.1177/0310057X0303100507.
- Background Snir M, Axer-Siegel R, Buckman G, Yassur Y. Central venous stasis retinopathy following the use of tranexamic acid. Retina. 1990;10(3):181-4.
- Background Kitamura H, Matsui I, Itoh N, Fujii T, Aizawa M, Yamamoto R, Okuno A, Okazaki Y, Fujita Y, Kuwayama Y, Imai E, Fujii M. Tranexamic acid-induced visual impairment in a hemodialysis patient. Clin Exp Nephrol. 2003 Dec;7(4):311-4. doi: 10.1007/s10157-003-0254-y.
- Background Kavanagh GM, Sansom JE, Harrison P, Warwick JA, Peachey RD. Tranexamic acid (Cyklokapron)-induced fixed-drug eruption. Br J Dermatol. 1993 Feb;128(2):229-30. doi: 10.1111/j.1365-2133.1993.tb15161.x. No abstract available.
- Background Carrion-Carrion C, del Pozo-Losada J, Gutierrez-Ramos R, de Lucas-Laguna R, Garcia-Diaz B, Casado-Jimenez M, Esperanza-Jimenez Caballero ME. Bullous eruption induced by tranexamic acid. Ann Pharmacother. 1994 Nov;28(11):1305-6. doi: 10.1177/106002809402801121. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tranexamic Acid | Small molecule | 1 mg/kg | Intravenous |