Stability of tranexamic acid after 12-week storage at temperatures from-20°C to 50°C

Prehospital Emergency Care

Volumn 17, Issue 3, 2013, Pages 394-400

  De Guzman, Rodolfo ^a   Polykratis, I Amy ^a   Sondeen, Jill L ^a   Darlington, Daniel N ^a   Cap, Andrew P ^a   Dubick, Michael A ^a  

^a US ARMY INSTITUTE OF SURGICAL RESEARCH   (United States)

Author keywords

HPLC; Storage; Temperature stability; Thromboelastography; Tranexamic acid

Indexed keywords

ANTIFIBRINOLYTIC AGENT; TRANEXAMIC ACID;

ARTICLE; CHEMISTRY; DRUG STABILITY; DRUG STORAGE; FEASIBILITY STUDY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; IN VITRO STUDY; TEMPERATURE; THROMBOELASTOGRAPHY;

ANTIFIBRINOLYTIC AGENTS; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DRUG STABILITY; DRUG STORAGE; FEASIBILITY STUDIES; HUMANS; TEMPERATURE; THROMBELASTOGRAPHY; TRANEXAMIC ACID; IN VITRO TECHNIQUES;

EID: 84878889772     PISSN: 10903127     EISSN: 15450066     Source Type: Journal    
DOI: 10.3109/10903127.2013.792891     Document Type: Article

References (27)

1. Blackbourne LH, Czarnik J, Mabry R, et al. Decreasing killed in action and died of wounds rates in combat wounded. J Trauma. 2010;69(suppl 1):S1-4.
2. Kelly JF, Ritenour AE, McLaughlin DF, et al. Injury severity and causes of death from Operation Iraqi Freedom and Operation Enduring Freedom: 2003-2004 versus 2006. J Trauma. 2008;64(suppl 1):S21-6; discussion S26-7.
3. Evans JA, van Wessem KJ, McDougall D, Lee KA, Lyons T, Balogh ZJ. Epidemiology of traumatic deaths: comprehensive population-based assessment. World J Surg. 2010;34:158-63.
4. Ngaage DL, Bland JM. Lessons from aprotinin: is the routine use and inconsistent dosing of tranexamic acid prudent? Meta-analysis of randomised and large matched observational studies. Eur J Cardiothorac Surg. 2010;37:1375-83.
5. Zhang H, Chen J, Chen F, Que W. The effect of tranexamic acid on blood loss and use of blood products in total knee arthro-plasty: a meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2012;20:1742-52.
6. Shakur H, Roberts I, Bautista R, et al. 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. Lancet. 2010;376:23-32.
7. Morrison JJ, Dubose JJ, Rasmussen TE, Midwinter MJ. Military Application of Tranexamic acid in Trauma Emergency Resuscitation (MATTERS) Study. Arch Surg. 2012;147:113-9
8. Joint Theater Trauma Systems. Damage control resuscitation at level IIb/III treatment facilities. Clinical Practice Guideline. 2013. Available at: http://www.usaisr.amedd.army.mil/assets/cpgs/ Damage%20Control%20Resuscitation%20-%201%20Feb%202013.pdf. (accessed 2 May 2013).
9. Roberts I, Shakur H, Afolabi A, et al. The importance of early treatment with tranexamic acid in bleeding trauma patients: an exploratory analysis of the CRASH-2 randomised controlled trial. Lancet. 2011;377:1096-1101, 1101 e1091-1092.
10. Brown LH, Krumperman K, Fullagar CJ. Out-of-hospital medication storage temperatures: a review of the literature and directions for the future. Prehosp Emerg Care. 2004;8: 200-6. (Pubitemid 38501192)
11. Food and Drug Administration. Guidance for industry. Q1a(r2) stability testing of new drug substances and products. 2003.
12. Department of Defense. Shelf-Life Management Manual. Washington, DC: Department of Defense, 2005.
13. Rijken DC, Sakharov DV. Molecular transport during fibrin clot lysis. Fibrinol Proteol. 2000;14:98-113. (Pubitemid 30409284)
14. Rijken DC, Sakharov DV. Basic principles in thrombolysis: regulatory role of plasminogen. Thromb Res. 2001;103(suppl 1):S41-9.
15. Maksimenko AV, Tischenko EG. Macromolecular ensembles of internal and external fibrinolysis: the resources for enhancement of thrombolysis efficacy. Curr Med Chem. 2006;13:1617-25. (Pubitemid 43821695)
16. Godier A, Roberts I, Hunt BJ. Tranexamic acid: less bleeding and less thrombosis? Crit Care. 2012;16:135.
17. Roberts I, Shakur H, Ker K, Coats T. Antifibrinolytic drugs for acute traumatic injury. Cochrane Database Syst Rev. 2011:CD004896.
18. Frith D, Brohi K. The pathophysiology of trauma-induced co-agulopathy. Curr Opin Crit Care. 2012;18:631-6.
19. Niles SE, McLaughlin DF, Perkins JG, et al. Increased mortality associated with the early coagulopathy of trauma in combat casualties. J Trauma. 2008;64:1459-63; discussion 1463-65.
20. Cotton BA, Harvin JA, Kostousouv V, et al. Hyperfibrinolysis at admission is an uncommon but highly lethal event associated with shock and prehospital fluid administration. J Trauma Acute Care Surg. 2012;73:365-70; discussion 370.
21. Kutcher ME, Cripps MW, McCreery RC, et al. Criteria for empiric treatment of hyperfibrinolysis after trauma. J Trauma Acute Care Surg. 2012;73:87-93.
22. Schochl H, Voelckel W, Maegele M, Solomon C. Trauma-associated hyperfibrinolysis. Hamostaseologie. 2012;32:22-7.
23. Theusinger OM, Wanner GA, Emmert MY, et al. Hyperfibri-nolysis diagnosed by rotational thromboelastometry (ROTEM) is associated with higher mortality in patients with severe trauma. Anesth Analg. 2011;113:1003-12.
24. Ives C, Inaba K, Branco BC, et al. Hyperfibrinolysis elicited via thromboelastography predicts mortality in trauma. J Am Coll Surg. 2012;215:496-502.
25. Hoffmann JJ, Vijgen M. Prevention of in vitro fibrinogenol-ysis during laboratory monitoring of thrombolytic therapy with streptokinase or APSAC. Blood Coagul Fibrinolysis. 1991;2:279-84.
26. Pfizer Canada Inc. Product monograph cyklokapron. Quebec City, Canada. 2010. Available at: http://www.pfizer.ca/en/our products/products/monograph/195. (date accessed 6 Feb 2013).
27. Pfizer Inc. Cyklokapron tranexamic acid injection. New York, NY. 2011. Available at: http://www.accessdata.fda.gov/drugsatfda docs/label/2011/ 019281s030lbl.pdf. (date accessed 6 Feb 2013).