TXA Study in Major Burn Surgery

Summary

Major surgery can result in blood loss that can require a blood transfusion during and/or after surgery. Tranexamic acid (TXA) is a medication that was first introduced in the 1960's as a treatment for heavy menstrual bleeding. Over the past 20 years, it has been used and studied in patients undergoing open-heart surgery, liver transplantation, and urologic surgery. Investigators believe tranexamic acid may possibly decrease bleeding related to major burn surgery, resulting in reduced blood loss, lower blood transfusion rates, and possibly decreased hospital costs related to your stay. In this study, prior to each surgical procedure to treat the participants burn injury, the participant will receive either the drug tranexamic acid or placebo. The placebo is a liquid that looks like the tranexamic acid medicine, but does not have any active ingredient in it. In this study, both the tranexamic acid and the placebo are considered research.

Timeline

Start

2016-04

Primary completion

2019-12-03

Completion

2019-12-03

Outcome

Outcome not reported

Stopped (Enrollment): “Study enrollment and goals unable to be reached.”

Publications

• Background Engrav LH, Heimbach DM, Reus JL, Harnar TJ, Marvin JA. Early excision and grafting vs. nonoperative treatment of burns of indeterminant depth: a randomized prospective study. J Trauma. 1983 Nov;23(11):1001-4. doi: 10.1097/00005373-198311000-00007.
• Background Ong YS, Samuel M, Song C. Meta-analysis of early excision of burns. Burns. 2006 Mar;32(2):145-50. doi: 10.1016/j.burns.2005.09.005. Epub 2006 Jan 18.
• Background Desai MH, Herndon DN, Broemeling L, Barrow RE, Nichols RJ Jr, Rutan RL. Early burn wound excision significantly reduces blood loss. Ann Surg. 1990 Jun;211(6):753-9; discussion 759-62. doi: 10.1097/00000658-199006000-00015.
• Background Curinga G, Jain A, Feldman M, Prosciak M, Phillips B, Milner S. Red blood cell transfusion following burn. Burns. 2011 Aug;37(5):742-52. doi: 10.1016/j.burns.2011.01.016. Epub 2011 Mar 1.
• Background Muller M, Gahankari D, Herndon DN. Operative wound management. Total burn care. 2007;3:177-195.
• Background Vermylen J, Verhaegen-Declercq ML, Fierens F, Verstraete M. A double blind study of the effect of tranexamic acid in essential menorrhagia. Bull Soc R Belge Gynecol Obstet. 1968;38(5):385-90. No abstract available.
• Background Prentice CR. Basis of antifibrinolytic therapy. J Clin Pathol Suppl (R Coll Pathol). 1980;14:35-40. No abstract available.
• Background Wei W, Wei B. Comparison of topical and intravenous tranexamic acid on blood loss and transfusion rates in total hip arthroplasty. J Arthroplasty. 2014 Nov;29(11):2113-6. doi: 10.1016/j.arth.2014.07.019. Epub 2014 Jul 30.
• Background Patatanian E, Fugate SE. Hemostatic mouthwashes in anticoagulated patients undergoing dental extraction. Ann Pharmacother. 2006 Dec;40(12):2205-10. doi: 10.1345/aph.1H295. Epub 2006 Nov 7.
• Background Mangano DT, Tudor IC, Dietzel C; Multicenter Study of Perioperative Ischemia Research Group; Ischemia Research and Education Foundation. The risk associated with aprotinin in cardiac surgery. N Engl J Med. 2006 Jan 26;354(4):353-65. doi: 10.1056/NEJMoa051379.
• Background Williams-Johnson JA, McDonald AH, Strachan GG, Williams EW. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2) A randomised, placebo-controlled trial. West Indian Med J. 2010 Dec;59(6):612-24.
• Background Jennes S, Degrave E, Despiegeleer X, Grenez O. Effect of tranexamic acid on blood loss in burn surgery: A preliminary study: 33. Journal of Burn Care & Research. 2003;24:S59.
• Background Tang YM, Chapman TW, Brooks P. Use of tranexamic acid to reduce bleeding in burns surgery. J Plast Reconstr Aesthet Surg. 2012 May;65(5):684-6. doi: 10.1016/j.bjps.2011.09.028. Epub 2011 Oct 7.
• Background Poeran J, Rasul R, Suzuki S, Danninger T, Mazumdar M, Opperer M, Boettner F, Memtsoudis SG. Tranexamic acid use and postoperative outcomes in patients undergoing total hip or knee arthroplasty in the United States: retrospective analysis of effectiveness and safety. BMJ. 2014 Aug 12;349:g4829. doi: 10.1136/bmj.g4829.
• Background Satahoo SS, Parikh PP, Naranjo D, Davis JS, Duncan RC, Pizano LR, Namias N, Schulman CI. Are burn patients really at risk for thrombotic events? J Burn Care Res. 2015 Jan-Feb;36(1):100-4. doi: 10.1097/BCR.0000000000000093.
• Background Twisk JWR. Applied Multilevel Analysis: A Practical Guide for Medical Researchers. 2006. Cambridge University Press, London, UK.
• Background American Burn Association. Burn incidence fact sheet. http://www.ameriburn.org/resources_factsheet.php. Accessed May 20, 2015.

Drugs

Indications

No indication recorded.