Effect of early tranexamic acid treatment on fatigue in patients with mild traumatic brain injury: data from the CRASH-3 clinical trial

Raoul Mansukhani ORCID logo; Antonio Belli; Amy Brenner ORCID logo; Rizwana Chaudhri ORCID logo; Lauren Frimley; Sabariah Faizah Jamaluddin; Rashid Jooma; Haleema Shakur-Still ORCID logo; Temitayo Shokunbi ORCID logo; Ian Roberts ORCID logo; (2021) Effect of early tranexamic acid treatment on fatigue in patients with mild traumatic brain injury: data from the CRASH-3 clinical trial. Wellcome Open Research, 6. p. 346. DOI: 10.12688/wellcomeopenres.17421.1
Copy

<ns4:p><ns4:bold>Background:</ns4:bold> Each year world-wide about 65 million people sustain a mild traumatic brain injury (mTBI). Fatigue is a common and distressing symptom after mTBI. We examine the effect of tranexamic acid (TXA) on fatigue in patients with mTBI using data from the CRASH-3 trial.</ns4:p><ns4:p> <ns4:bold>Methods:</ns4:bold> The CRASH-3 trial randomised 9,202 patients with traumatic brain injury and no significant extracranial bleeding to receive TXA or placebo within 3 hours of injury. The primary outcome was death from head injury within 28 days of injury. The methods and results are presented elsewhere. Fatigue was recorded as “None”, “Moderate” or “Extreme.” This study examines the effect of TXA on extreme fatigue in the 2,632 patients with mTBI (Glasgow Coma Scale [GCS] score≥13). Our analyses were not prespecified.</ns4:p><ns4:p> <ns4:bold>Results:</ns4:bold> Our study primary outcome, extreme fatigue, was reported for 10 (0.8%) of 1,328 patients receiving TXA and 19 (1.5%) of 1,288 patients receiving placebo (risk ratio [RR]=0.51, 95% confidence interval [CI] 0.24-1.09). Death within 28 days of injury was reported for 34 (2.6%) of 1,328 patients receiving TXA versus 47 (3.6%) of 1,288 patients receiving placebo (RR=0.70, 95% CI 0.45-1.08). Among patients allocated to TXA, 44 (3.3%) patients either died or reported extreme fatigue versus 66 (5.1%) patients among those allocated to placebo (RR=0.65, 95% CI 0.44-0.94).</ns4:p><ns4:p> <ns4:bold>Conclusions:</ns4:bold> Early tranexamic acid treatment may reduce fatigue in mTBI patients, but these results need to be confirmed in a larger trial.</ns4:p><ns4:p> <ns4:bold>Registration:</ns4:bold> ISRCTN (ISRCTN15088122, 19/07/2011), ClinicalTrials.gov (NCT01402882, 26/07/2011), EudraCT (2011-003669-14, 25/07/2011), Pan African Clinical Trial Registry (PACTR20121000441277, 30/10/2012).</ns4:p>

picture_as_pdf

picture_as_pdf
85f66ad7-2529-4a4e-9720-659317096fff_17421_-_raoul_mansukhani.pdf
subject
Published Version
Available under Creative Commons: 4.0

View Download

Atom BibTeX OpenURL ContextObject in Span Multiline CSV OpenURL ContextObject Dublin Core Dublin Core MPEG-21 DIDL EndNote HTML Citation JSON MARC (ASCII) MARC (ISO 2709) METS MODS RDF+N3 RDF+N-Triples RDF+XML RIOXX2 XML Reference Manager Refer Simple Metadata ASCII Citation EP3 XML
Export

Downloads