Background: 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.
Methods: 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.
Results: 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). This composite outcome is disproportionately influenced by deaths which account for 74% (81 from 110) of events.
Conclusions: We found no evidence that tranexamic acid reduces fatigue in patients with mTBI. Given, 1) our analyses were not prespecified, 2) our outcome measure is not based on a validated fatigue severity scale, and 3) TBI patients can suffer from hospital-induced delirium, which hinders clinician assessment, these results need to be replicated in another study.
Registration: 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).
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http://dx.doi.org/10.12688/wellcomeopenres.17421.2 | DOI Listing |
Adv Ther
December 2024
GSK, US Value Evidence and Outcomes, Collegeville, PA, 19426-0989, USA.
Introduction: Chronic obstructive pulmonary disease (COPD) is associated with exacerbations which can reduce quality of life and increase mortality. Single-inhaler triple therapy (SITT) is recommended for maintenance treatment of COPD among patients experiencing exacerbations despite dual-therapy use. This real-world comparative effectiveness study compared the impact of SITTs, fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI), and budesonide/glycopyrrolate/formoterol fumarate (BUD/GLY/FORM), on COPD exacerbations and mortality.
View Article and Find Full Text PDFClin J Gastroenterol
December 2024
Department of Gastroenterology and Hepatology, Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital, 3-35 Michishita-cho, Nakamura-ku, Nagoya, 453-8511, Japan.
Intravesical Bacillus Calmette-Guérin (BCG) immunotherapy for bladder cancer rarely leads to disseminated BCG infections, most of which occur early after BCG instillations or in immunocompromised patients. We report late-onset disseminated BCG infection after intravesical BCG immunotherapy in a non-immunocompromised patient. A 78-year-old non-immunocompromised man was admitted with fever and hepatosplenomegaly.
View Article and Find Full Text PDFJ Autism Dev Disord
December 2024
Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, 1977 Butler Boulevard, Houston, TX, 77030, USA.
Parent-led cognitive behavioral therapy (CBT) is an efficient, promising form of therapy that may be well suited for autistic youth with anxiety disorders. A recent clinical trial found that parent-led CBT - in which parents led their child through a guided CBT workbook with varying degrees of therapist support - was efficacious for reducing anxiety and associated functional impairment. While such findings demonstrate promise for future intervention development and dissemination efforts with this population, more work is needed to elucidate clinical factors that impact response to treatment as well as drop-out.
View Article and Find Full Text PDFTranspl Infect Dis
December 2024
Department of Medicine, Section of Infectious Diseases, Mayo Clinic, Rochester, Minnesota, USA.
Introduction: With reports of expanding epidemiology of blastomycosis across the United States, the purpose of this study was to evaluate the incidence and outcomes associated with blastomycosis in solid organ transplant (SOT) and hematopoietic cell transplant (HCT) recipients.
Methods: We conducted a retrospective case series of adult SOT and HCT recipients at a tertiary care medical center between January 1, 2005 and September 30, 2023. Cases were defined as culture-proven blastomycosis.
Acta Neurochir (Wien)
December 2024
Department of Neurosurgery, Addenbrooke's Hospital, University of Cambridge, Cambridge, UK.
Objectives: To report the results of an international patient-reported survey that adds to the growing body of evidence surrounding the role of surgery in the management of a subset of patients with non-hydrocephalic symptomatic pineal cyst.
Design: An international web-based survey of health outcomes in patients with nhSPC.
Subjects: All survey participants who self-reported a diagnosis of symptomatic pineal cyst without hydrocephalus after radiological imaging.
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