Displaying publications 21 - 22 of 22 in total

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  1. Administration of tranexamic acid for victims of severe trauma within pre-hospital care ambulance services (PHCAS) in Malaysia
    Shah Jahan MY, Shamila MA, Nurul Azlean N, Mohd Amin M, Anandakumar K, Ahmad Ibrahim KB, et al.
    Med J Malaysia, 2019 08;74(4):300-306.
    PMID: 31424037
    INTRODUCTION: Trauma is a Global threat and the 5th highest cause of all-cause mortality in Malaysia caused predominantly due to road traffic accidents. Majority of trauma victims are young adults aged between 21-40 years old. In Malaysia, 24 out of 100,000 population die annually due to trauma, rating us amongst the highest in South East Asia. These alarming figures justify aggressive preventive and mitigation strategies. The aim of this paper is to promote the implementation of evidence-based interventions that will reduce the rate of preventable death because of trauma. Tranexamic acid is one of the few interventions in the early management of severe trauma with level-one evidence. Tranexamic acid has been proven to reduce all causes of mortality and mortality due to bleeding. Evidence proves that it is most effective when administered early, particularly within the 1st hour of trauma. This proposed guideline is formulated based upon quality evidence from multicentre studies, clinical practices in other countries and consideration of the local demographic factors with the intent of enabling an easy and simple pathway to administer tranexamic acid early in the care of the severely injured.

    CONCLUSION: The guideline highlights select pre-hospital criteria's and the methods for drug administration. The authors recognise that some variants may be present amongst certain institutions necessitating minor adaptations, nevertheless the core principles of advocating tranexamic acid early in the course of pre-hospital trauma should be adhered to.

    Matched MeSH terms: Tranexamic Acid/administration & dosage*; Tranexamic Acid/therapeutic use
  2. Fulltext Statistical analysis plan for the 'Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage' (TICH-2) trial
    Flaherty K, Bath PM, Dineen R, Law Z, Scutt P, Pocock S, et al.
    Trials, 2017 Dec 20;18(1):607.
    PMID: 29262841 DOI: 10.1186/s13063-017-2341-5
    RATIONALE: Aside from blood pressure lowering, treatment options for intracerebral haemorrhage remain limited and a proportion of patients will undergo early haematoma expansion with resultant significant morbidity and mortality. Tranexamic acid (TXA), an anti-fibrinolytic drug, has been shown to significantly reduce mortality in patients, who are bleeding following trauma, when given rapidly. TICH-2 is testing whether TXA is effective at improving outcome in spontaneous intracerebral haemorrhage (SICH).

    METHODS AND DESIGN: TICH-2 is a pragmatic, phase III, prospective, double-blind, randomised placebo-controlled trial. Two thousand adult (aged ≥ 18 years) patients with an acute SICH, within 8 h of stroke onset, will be randomised to receive TXA or the placebo control. The primary outcome is ordinal shift of modified Rankin Scale score at day 90. Analyses will be performed using intention-to-treat.

    RESULTS: This paper and its attached appendices describe the statistical analysis plan (SAP) for the trial and were developed and published prior to database lock and unblinding to treatment allocation. The SAP includes details of analyses to be undertaken and unpopulated tables which will be reported in the primary and key secondary publications. The database will be locked in early 2018, ready for publication of the results later in the same year.

    DISCUSSION: The SAP details the analyses that will be done to avoid bias arising from prior knowledge of the study findings. The trial will determine whether TXA can improve outcome after SICH, which currently has no definitive therapy.

    TRIAL REGISTRATION: ISRCTN registry, ID: ISRCTN93732214 . Registered on 17 January 2013.

    Matched MeSH terms: Tranexamic Acid/adverse effects; Tranexamic Acid/therapeutic use*
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