Stability of Tranexamic Acid after 12-Week Storage at Temperatures from –20°C to 50°C

Guzman, Rodolfo de; Polykratis, I. Amy; Sondeen, Jill L.; Darlington, Daniel N.; Andrew, P.; Dubick, Michael A.

doi:10.3109/10903127.2013.792891

Cited by 16 publications

(16 citation statements)

References 20 publications

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“…TXA is stable in a wide variety of field conditions for up to 12 weeks. 41 The prehospital phase includes the intervention arm in which subjects receive 1 g of TXA or the control arm in which subjects receive 1 g of identical placebo. Both TXA and the placebo will be diluted in 100 mL of normal saline (prepared on the helicopter) and infused intravenously over 10 minutes.…”

Section: Design Of the Staamp Trialmentioning

confidence: 99%

Design of the Study of Tranexamic Acid during Air Medical Prehospital Transport (STAAMP) Trial: Addressing the Knowledge Gaps

Brown¹,

Neal²,

Guyette³

et al. 2014

Prehospital Emergency Care

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Hemorrhage and coagulopathy remain major drivers of early preventable mortality in military and civilian trauma. The development of trauma-induced coagulopathy and hyperfibrinolysis is associated with poor outcomes. Interest in the use of tranexamic acid (TXA) in hemorrhaging patients as an antifibrinolytic agent has grown recently. Additionally, several reports describe immunomodulatory effects of TXA that may confer benefit independent of its antifibrinolytic actions. A large trial demonstrated a mortality benefit for early TXA administration in patients at risk for hemorrhage; however, questions remain about the applicability in developed trauma systems and the mechanism by which TXA reduces mortality. We describe here the rationale, design, and challenges of the Study of Tranexamic Acid during Air Medical Prehospital transport (STAAMP) trial. The primary objective is to determine the effect of prehospital TXA infusion during air medical transport on 30-day mortality in patients at risk of traumatic hemorrhage. This study is a multicenter, placebo-controlled, double-blind, randomized clinical trial. The trial will enroll trauma patients with hypotension and tachycardia from 4 level I trauma center air medical trans- port programs. It includes a 2-phase intervention, with a prehospital and in-hospital phase to investigate multiple dosing regimens. The trial will also explore the effects of TXA on the coagulation and inflammatory response following injury. The trial will be conducted under exception for informed consent for emergency research and thus required an investigational new drug approval from the U.S. Food and Drug Administration as well as a community consultation process. It was designed to address several existing knowledge gaps and research priorities regarding TXA use in trauma.

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Section: Design Of the Staamp Trialmentioning

confidence: 99%

Design of the Study of Tranexamic Acid during Air Medical Prehospital Transport (STAAMP) Trial: Addressing the Knowledge Gaps

Brown¹,

Neal²,

Guyette³

et al. 2014

Prehospital Emergency Care

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“…8,9 Tranexamic acid is heat-stable, inexpensive, and widely available and has a long shelf life. 10,11 The World Maternal Antifibrinolytic (WOMAN) trial, for which we were investigators, showed that the early administration of tranexamic acid led to a lower risk of death due to bleeding than placebo among women with postpartum hemorrhage and had an acceptable safety profile. 12 The treatment was similarly effective when bleeding was attributable to uterine atony.…”

Section: Finding Better Ways To Prevent Postpartum Hemorrhagementioning

confidence: 99%

Finding Better Ways to Prevent Postpartum Hemorrhage

Shakur-Still

Roberts

2018

N Engl J Med

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“…The CRASH-2 study has shown a decrease in mortality with the administration of TXA if administered within the first 3 hours following the injury 37 38. Moreover, TXA is cheap, not altered by extreme temperatures39 and remains efficient even in the face of acidosis 40. Widely used in civilian health systems, TXA has proven its benefit on the battlefield with the MATTERs study41 and is nowadays part of the tactical combat casualty care 4 42…”

Section: Haemostatic Resuscitationmentioning

confidence: 99%

Tactical damage control resuscitation in austere military environments

Daniel¹,

Habas²,

Malan³

et al. 2016

J R Army Med Corps

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In tactical situations, in association with haemostatic procedures (tourniquet, suture, etc), tranexamic acid should be the first medication used according to the current guidelines. The use of fibrinogen concentrate should also be considered for patients in haemorrhagic shock, especially if point-of-care (POC) testing of haemostasis or shock severity is available. If POC evaluation is not available, it seems reasonable to still administer this treatment after clinical assessment, particularly if the evacuation is delayed. In this situation, lyophilised plasma may also be given as a resuscitation fluid while respecting permissive hypotension. Whole blood transfusion in the field deserves special attention. In addition to the aforementioned treatments, if the field care is prolonged, whole blood transfusion must be considered if it does not delay the evacuation.

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Stability of Tranexamic Acid after 12-Week Storage at Temperatures from –20°C to 50°C

Abstract: Except for the finding that TXA ampoules cracked when frozen, this study indicated that the drug remains effective when stored under conditions likely to be encountered in the prehospital environment and outside the manufacturer's recommended temperature range for at least 12 weeks.

Cited by 16 publications

References 20 publications

Design of the Study of Tranexamic Acid during Air Medical Prehospital Transport (STAAMP) Trial: Addressing the Knowledge Gaps

Design of the Study of Tranexamic Acid during Air Medical Prehospital Transport (STAAMP) Trial: Addressing the Knowledge Gaps

Finding Better Ways to Prevent Postpartum Hemorrhage

Tactical damage control resuscitation in austere military environments

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