Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage (TICH-2): an international randomised, placebo-controlled, phase 3 superiority trial

BackgroundTranexamic acid (TXA) reduces death due to bleeding after trauma and post-partum haemorrhage. The aim was to assess if tranexamic acid reduces haematoma expansion and improves outcome in adults with stroke due to intracerebral 6 haemorrhage (ICH). MethodsWe undertook an international, randomised placebo-controlled trial in adults with intracerebral haemorrhage. Participants received 1g intravenous tranexamic acid bolus followed by an 8 hour 1g infusion, or matching placebo, within 8 hours of symptom onset. The primary outcome was functional status at day 90, measured by shift in the modified Rankin Scale (mRS), using ordinal logistic regression, with adjustment for stratification and minimisation criteria. All analyses were performed on an intention to treat basis. This trial is registered as ISRCTN93732214.FindingsWe recruited 2,325 participants (TXA 1161, placebo 1164) from 124 hospitals in 12 countries between 2013 and 2017. Treatment groups were well balanced at baseline. The primary outcome was determined for 2307 (99·2%) participants. There was no statistically significant difference between the groups for the primary outcome of functional status at day 90 (adjusted odds ratio [aOR] 0·88, 95% CI 0·76-1·03, p=0·11). Although there were fewer deaths by day 7 in the TXA group (aOR 0·73, 95% CI 0·53-0·99, p=0·0406), there was no difference in case fatality at 90 days (adjusted hazard ratio 0·92, 95% CI 0·77 to 1·10, p =0·37). There were fewer serious adverse events after TXA vs. placebo by days 2 (p=0·0272), 7 (p=0·0200) and 90 (p=0·0393).InterpretationThere was no significant difference in functional status 90 days after intracerebral haemorrhage with tranexamic acid, despite a reduction in early deaths and serious adverse events. Larger randomised trials are needed to confirm or refute a clinically significant treatment effect

FM BMJ

This small non-randomized clinical trial incorporated an intervention group (subjects 1-4) and a standard care group (subjects 5-9). Outcome assessments were conducted during visit 1 and visit 2 at 10 weeks later. The outcome assessment tool was the Bamford- Kowal-Bench (BKB) sentence test presented against a 20-talker babble noise, conducted within the “crescent of sound” booth.The BKB sentences were presented from the loudspeaker positioned at 0° azimuth to the participant with the babble coming: a. from the same loudspeaker at 0°at the front b. from the loudspeaker 90° to the left (-90°). c. from the loudspeaker 90° to the right (+90°). The test was conducted with the participant using the FM (aided condition) or not using the FM (unaided condition). Microsoft Excel for Mac 2010 was used to create the data file. Side column denotes side of stroke lesion: 0(right lesion) 1(left lesion); Gender: 1 (male), 2(female); Group: 1(intervention) 0 (standard care

Auditory rehabilitation after stroke: treatment of auditory processing disorders in stroke patients with personal frequency-modulated (FM) systems

<p><b>Purpose:</b> Auditory disability due to impaired auditory processing (AP) despite normal pure-tone thresholds is common after stroke, and it leads to isolation, reduced quality of life and physical decline. There are currently no proven remedial interventions for AP deficits in stroke patients. This is the first study to investigate the benefits of personal frequency-modulated (FM) systems in stroke patients with disordered AP. <b>Methods:</b> Fifty stroke patients had baseline audiological assessments, AP tests and completed the (modified) Amsterdam Inventory for Auditory Disability and Hearing Handicap Inventory for Elderly questionnaires. Nine out of these 50 patients were diagnosed with disordered AP based on severe deficits in understanding speech in background noise but with normal pure-tone thresholds. These nine patients underwent spatial speech-in-noise testing in a sound-attenuating chamber (the “crescent of sound”) with and without FM systems. <b>Results:</b> The signal-to-noise ratio (SNR) for 50% correct speech recognition performance was measured with speech presented from 0° azimuth and competing babble from ±90° azimuth. Spatial release from masking (SRM) was defined as the difference between SNRs measured with co-located speech and babble and SNRs measured with spatially separated speech and babble. The SRM significantly improved when babble was spatially separated from target speech, while the patients had the FM systems in their ears compared to without the FM systems. <b>Conclusions:</b> Personal FM systems may substantially improve speech-in-noise deficits in stroke patients who are not eligible for conventional hearing aids. FMs are feasible in stroke patients and show promise to address impaired AP after stroke.Implications for Rehabilitation</p><p>This is the first study to investigate the benefits of personal frequency-modulated (FM) systems in stroke patients with disordered AP.</p><p>All cases significantly improved speech perception in noise with the FM systems, when noise was spatially separated from the speech signal by 90° compared with unaided listening.</p><p>Personal FM systems are feasible in stroke patients, and may be of benefit in just under 20% of this population, who are not eligible for conventional hearing aids.</p><p></p> <p>This is the first study to investigate the benefits of personal frequency-modulated (FM) systems in stroke patients with disordered AP.</p> <p>All cases significantly improved speech perception in noise with the FM systems, when noise was spatially separated from the speech signal by 90° compared with unaided listening.</p> <p>Personal FM systems are feasible in stroke patients, and may be of benefit in just under 20% of this population, who are not eligible for conventional hearing aids.</p