Consent for Brain Tissue Donation after Intracerebral Haemorrhage: A Community-Based Study.

BACKGROUND: Spontaneous intracerebral haemorrhage is a devastating form of stroke and its incidence increases with age. Obtaining brain tissue following intracerebral haemorrhage helps to understand its cause. Given declining autopsy rates worldwide, the feasibility of establishing an autopsy-based collection and its generalisability are uncertain. METHODS: We used multiple overlapping sources of case ascertainment to identify every adult diagnosed with intracerebral haemorrhage between 1st June 2010-31st May 2012, whilst resident in the Lothian region of Scotland. We sought consent from patients with intracerebral haemorrhage (or their nearest relative if the patient lacked mental capacity) to conduct a research autopsy. RESULTS: Of 295 adults with acute intracerebral haemorrhage, 110 (37%) could not be approached to consider donation. Of 185 adults/relatives approached, 91 (49%) consented to research autopsy. There were no differences in baseline demographic variables or markers of intracerebral haemorrhage severity between consenters and non-consenters. Adults who died and became donors (n = 46) differed from the rest of the cohort (n = 249) by being older (median age 80, IQR 76-86 vs. 75, IQR 65-83, p = 0.002) and having larger haemorrhages (median volume 23 ml, IQR 13-50 vs. 13 ml, IQR 4-40; p = 0.002). CONCLUSIONS: Nearly half of those approached consent to brain tissue donation after acute intracerebral haemorrhage. The characteristics of adults who gave consent were comparable to those in an entire community, although those who donate early are older and have larger haemorrhage volumes.

Influence of intracerebral hemorrhage location on incidence, characteristics, and outcome: population-based study.

BACKGROUND AND PURPOSE: The characteristics of intracerebral hemorrhage (ICH) may vary by ICH location because of differences in the distribution of underlying cerebral small vessel diseases. Therefore, we investigated the incidence, characteristics, and outcome of lobar and nonlobar ICH. METHODS: In a population-based, prospective inception cohort study of ICH, we used multiple overlapping sources of case ascertainment and follow-up to identify and validate ICH diagnoses in 2010 to 2011 in an adult population of 695 335. RESULTS: There were 128 participants with first-ever primary ICH. The overall incidence of lobar ICH was similar to nonlobar ICH (9.8 [95% confidence interval, 7.7-12.4] versus 8.6 [95% confidence interval, 6.7-11.1] per 100 000 adults/y). At baseline, adults with lobar ICH were more likely to have preceding dementia (21% versus 5%; P=0.01), lower Glasgow Coma Scale scores (median, 13 versus 14; P=0.03), larger ICHs (median, 38 versus 11 mL; P<0.001), subarachnoid extension (57% versus 5%; P<0.001), and subdural extension (15% versus 3%; P=0.02) than those with nonlobar ICH. One-year case fatality was lower after lobar ICH than after nonlobar ICH (adjusted odds ratio for death at 1 year: lobar versus nonlobar ICH 0.21; 95% confidence interval, 0.07-0.63; P=0.006, after adjustment for known predictors of outcome). There were 4 recurrent ICHs, which occurred exclusively in survivors of lobar ICH (annual risk of recurrent ICH after lobar ICH, 11.8%; 95% confidence interval, 4.6%-28.5% versus 0% after nonlobar ICH; log-rank P=0.04). CONCLUSIONS: The baseline characteristics and outcome of lobar ICH differ from other locations.

Long-term prognosis after intracerebral haemorrhage: systematic review and meta-analysis.

BACKGROUND AND AIM: There is uncertainty about the long-term prognosis after spontaneous intracerebral haemorrhage (ICH). Therefore, we systematically reviewed the literature for studies reporting long-term survival and ICH recurrence, and their predictors. METHODS: We searched Ovid Medline 1946-2011 inclusive for cohort studies of ≥50 patients reporting long-term (>30 days) outcome after ICH. Two reviewers independently extracted data from each study. We meta-analysed 1-year and 5-year survival data from population-based studies using a random effects model (and quantified inconsistency using the I2 statistic). RESULTS: We identified 122 eligible studies. The pooled estimate of 1-year survival was 46% (95% CI 43% to 49%; nine population-based studies (n=2408); I2=27%) and 5-year survival was 29% (95% CI 26% to 33%; three population-based studies (n=699); I2=6%). In 27 cohort studies, predictors most consistently associated with death were increasing age, decreasing Glasgow Coma Scale score, increasing ICH volume, presence of intraventricular haemorrhage, and deep/infratentorial ICH location. The annual risk of recurrent ICH varied from 1.3% to 7.4% in nine studies and this risk was higher after lobar ICH than non-lobar ICH in two of three hospital-based studies. Four studies reporting the risks of recurrent ICH and ischaemic stroke after ICH found no significant differences between these risks. CONCLUSIONS: Less than a half of patients with ICH survive 1 year and less than a third survive 5 years. Risks of recurrent ICH and ischaemic stroke after ICH appear similar after ICH, provoking uncertainties about the use of antithrombotic drugs.

Eligibility for randomized trials of treatments specifically for intracerebral hemorrhage: community-based study.

BACKGROUND AND PURPOSE: Acute treatments specifically for intracerebral hemorrhage (ICH) are being sought in randomized controlled trials. The treatment effect sizes in ongoing and future trials are likely to be small, necessitating large sample sizes. METHODS: We searched online trial registries for randomized controlled trials investigating an acute treatment for ICH. For the trials whose eligibility criteria could be assessed in a prospective, community-based ICH cohort study (2010-2011), we quantified the proportions of patients who were eligible and investigated influences on these proportions. RESULTS: We applied the eligibility criteria of 17 trials to 166 adults with ICH, of whom between 0.6% (95% confidence interval, 0.1-3.3) to 40% (95% confidence interval, 33-48) were eligible for each trial. Fewer patients were eligible for trials restricted to patients randomized within 12 hours of ICH onset (versus trials with a longer time window; P=0.03) and trials restricting eligibility according to premorbid disability (versus trials without this restriction; P=0.046). Each additional eligibility criterion reduced the portion of eligible patients by 1.3% (95% confidence interval, 0.4-2.2; adjusted R(2)=0.47; P=0.004). CONCLUSIONS: Less than half of patients with ICH were eligible for current randomized controlled trials. Future trials could maximize enrollment by minimizing the number of eligibility criteria, maximizing the time window for recruiting patients after ICH onset, permitting premorbid disability, and using a simulator to assess the impact of other eligibility critiera (www.dcn.ed.ac.uk/ICHsimulator/).