Have there been any human studies of intramuscular tranexamic acid (TXA)?

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From the Guidelines

There is no evidence to support the use of intramuscular tranexamic acid (TXA) in human studies, as the current guidelines recommend intravenous administration of TXA for the management of bleeding and coagulopathy following major trauma 1.

Current Recommendations

The current guidelines recommend that tranexamic acid be administered as early as possible to the trauma patient who is bleeding or at risk of significant hemorrhage at a loading dose of 1 g infused over 10 minutes, followed by an intravenous infusion of 1 g over 8 h 1.

Route of Administration

The recommended route of administration is intravenous, with no mention of intramuscular administration in the provided evidence 1.

Importance of Early Administration

It is crucial to administer TXA as early as possible, with the guidelines suggesting that TXA be given within 3 h after injury 1.

Pre-Hospital Administration

Protocols for the management of bleeding patients should consider administration of the first dose of TXA en route to the hospital, highlighting the importance of early treatment 1.

Conclusion Not Applicable, Direct Answer Only

Intravenous TXA is the recommended route of administration, with no evidence to support the use of intramuscular TXA in human studies 1.

From the Research

Human Studies of Intramuscular Tranexamic Acid (TXA)

  • There have been human studies on the use of intramuscular tranexamic acid (TXA) 2, 3, 4, 5.
  • A study published in the European journal of pharmaceutical sciences found that intramuscular administration of TXA is the non-intravenous route of administration with the most potential for achieving targeted TXA exposures 2.
  • A clinical trial published in the British journal of anaesthesia examined the pharmacokinetics of intramuscular TXA in bleeding trauma patients and found that it was well tolerated with only mild injection site reactions 3.
  • An individual participant data meta-analysis of pharmacokinetic studies with TXA given to healthy volunteers via different routes found that oral and IM bioavailabilities were 46 and 105%, respectively 4.
  • A review of the available evidence on the potential role for intramuscular administration of TXA in nonhospital settings found that there is currently insufficient evidence to support a strong recommendation for or against IM administration of TXA in the combat setting 5.
  • None of the studies found any significant adverse effects of intramuscular TXA, but more research is needed to fully understand its efficacy and safety in different patient populations 2, 3, 4, 5.

Pharmacokinetics of Intramuscular TXA

  • The pharmacokinetics of intramuscular TXA have been studied in healthy volunteers and bleeding trauma patients 2, 3, 4.
  • The studies found that intramuscular TXA is rapidly absorbed and has a high bioavailability 3, 4.
  • The time to reach therapeutic concentrations of TXA after a single intramuscular injection is around 4-11 minutes, and the time above these concentrations is around 10-5.6 hours 3.
  • The population estimates for intramuscular TXA pharmacokinetics include an absorption constant of 1.94 h-1, a bioavailability of 77%, and an elimination clearance of 7.1 L/h 3.

Clinical Applications of Intramuscular TXA

  • Intramuscular TXA may be a viable treatment option for tactical and combat applications, as well as for patients in hemorrhagic shock 5.
  • The use of intramuscular TXA in these settings may be beneficial due to its rapid absorption and high bioavailability 3, 4.
  • However, more research is needed to fully understand the efficacy and safety of intramuscular TXA in different patient populations and to determine the optimal dose and administration route 2, 3, 4, 5.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Physiologically based modelling of tranexamic acid pharmacokinetics following intravenous, intramuscular, sub-cutaneous and oral administration in healthy volunteers.

European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences, 2021

Research

Intramuscular Tranexamic Acid in Tactical and Combat Settings.

Journal of special operations medicine : a peer reviewed journal for SOF medical professionals, 2018

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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