Dataset Information

Applicability of Clinical Trials in an Unselected Cohort of Patients With Intracerebral Hemorrhage.

ABSTRACT: Patient selection in clinical trials on intracerebral hemorrhage (ICH) affects overall applicability of results. We estimated eligibility for completed, ongoing, and planned clinical trials in an unselected cohort of patients with ICH.Large clinical ICH trials were identified using trial registration databases. Each trial's inclusion criteria were applied to a consecutive group of patients with ICH from the prospective hospital-based Lund Stroke Register. Survival status was obtained from the National Census Office and 90-day poor functional outcome (modified Rankin Scale ?4) from the Swedish Stroke Register or medical files.Among 253 patients with ICH, estimated eligibility proportions ranged between 2% and 36% for the 11 identified clinical trials. Patients not eligible for any trial (n=96) had more intraventricular hemorrhage, lower baseline level of consciousness, higher rates of cerebellar ICH, and lower rates of lobar ICH (P?0.001). Thirty-day case fatality for noneligible patients was 54% versus 18% among patients eligible in ?1 trial (95% confidence interval, 44%-64% versus 13%-25%; P<0.001). Noneligible ICH patients more frequently had poor functional outcome (75% versus 48%; 95% confidence interval, 65%-83% versus 40%-56%; P<0.001).There is large variation in proportions of patients with ICH eligible for inclusion in clinical trials and over a third of patients with ICH are not eligible for any trial.

SUBMITTER: Hansen BM

PROVIDER: S-EPMC5328273 | biostudies-literature | 2016 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Applicability of Clinical Trials in an Unselected Cohort of Patients With Intracerebral Hemorrhage.

Hansen Björn M BM Ullman Natalie N Norrving Bo B Hanley Daniel F DF Lindgren Arne A

Stroke 20160913 10

<h4>Background and purpose</h4>Patient selection in clinical trials on intracerebral hemorrhage (ICH) affects overall applicability of results. We estimated eligibility for completed, ongoing, and planned clinical trials in an unselected cohort of patients with ICH.<h4>Methods</h4>Large clinical ICH trials were identified using trial registration databases. Each trial's inclusion criteria were applied to a consecutive group of patients with ICH from the prospective hospital-based Lund Stroke Reg ...[more]

PMID: 27625384

Similar Datasets

Project description:Intracranial hemorrhage (ICH) occurs when a blood vessel ruptures in the brain. This leads to significant morbidity and mortality, the likelihood of which is predicated on the size of the bleeding event. X-ray computed tomography (CT) scans allow clinicians and researchers to qualitatively and quantitatively diagnose hemorrhagic stroke, guide interventions and determine inclusion criteria of patients in clinical trials. There is no currently available open source, validated tool to quickly segment hemorrhage. Using an automated pipeline and 2D and 3D deep neural networks, we show that we can quickly and accurately estimate ICH volume with high agreement with time-consuming manual segmentation. The training and validation datasets include significant heterogeneity in terms of pathology, such as the presence of intraventricular (IVH) or subdural hemorrhages (SDH) as well as variable image acquisition parameters. We show that deep neural networks trained with an appropriate anatomic context in the network receptive field, can effectively perform ICH segmentation, but those without enough context will overestimate hemorrhage along the skull and around calcifications in the ventricular system. We trained with all data from a multi-center phase II study (n = 112) achieving a best mean and median Dice coefficient of 0.914 and 0.919, a volume correlation of 0.979 and an average volume difference of 1.7 ml and root mean squared error of 4.7 ml in 500 out-of-sample scans from the corresponding multi-center phase III study. 3D networks with appropriate anatomic context outperformed both 2D and random forest models. Our results suggest that deep neural network models, when carefully developed can be incorporated into the workflow of an ICH clinical trial series to quickly and accurately segment ICH, estimate total hemorrhage volume and minimize segmentation failures. The model, weights and scripts for deployment are located at https://github.com/msharrock/deepbleed . This is the first publicly available neural network model for segmentation of ICH, the only model evaluated with the presence of both IVH and SDH and the only model validated in the workflow of a series of clinical trials.

Project description:Cytotoxic edema (CE) is an important form of perihematomal edema (PHE), which is a surrogate marker of secondary injury after intracerebral hemorrhage (ICH). However, knowledge about CE after ICH is insufficient. Whether CE has adverse effects on clinical outcomes of patients with ICH remains unknown. Therefore, we aimed to investigate the temporal pattern of CE and its association with clinical outcomes in patients with ICH. Data were derived from a randomized controlled study (comparing the deproteinized calf blood extract with placebo in patients with ICH). Intervention in this original study did not show any impact on hematoma and PHE volume, presence of CE, or clinical outcomes. We conducted our analysis in 20 patients who underwent magnetic resonance imaging with diffusion-weighted imaging (DWI) and apparent diffusion coefficient (ADC) images at day 3 and within 7-12 days after symptom onset. CE was defined as an elevated DWI b1000 signal and an ADC value reduced by > 10% compared with the mirror area of interest in the perihematomal region. The modified Rankin Scale (mRS), National Institutes of Health Stroke Scale (NIHSS), and Barthel Index (BI) were performed face to face at 30-day and 90-day follow-ups after ICH onset to assess the clinical outcomes of the patients. CE was detected in nearly two thirds of patients with ICH in our study and seemed to be reversible. CE within 7-12 days, rather than at day 3 after symptom onset, was associated with poor clinical outcome (mRS 3-6) at the 30-day follow-up (P = 0.020). In addition, compared with those without CE, patients with CE within 7-12 days had more severe neurological impairment measured by NIHSS score (P = 0.024) and worse daily life quality measured by BI (P = 0.004) at both the 30- and 90-day follow-ups. CE appears in the acute phase of ICH and might be reversible. CE within 7-12 days post ICH was related to poor outcomes, which provides a novel therapeutic target for ICH intervention.

Project description:BackgroundTo identify whether the risk of intracerebral hemorrhage is higher in patients with coronavirus disease 2019 (COVID-19), we compared the risk factors, comorbidities, and outcomes in patients intracerebral hemorrhage and COVID-19 and those without COVID-19.MethodsWe analyzed the data from the Cerner deidentified COVID-19 data set derived from 62 health care facilities. The data set included patients with an emergency department or inpatient encounter with discharge diagnoses codes that could be associated with suspicion of or exposure to COVID-19 or confirmed COVID-19.ResultsThere were a total of 154 (0.2%) and 667 (0.3%) patients with intracerebral hemorrhage among 85,645 patients with COVID-19 and 197,073 patients without COVID-19, respectively. In the multivariate model, there was a lower risk of intracerebral hemorrhage in patients with COVID-19 (odds ratio 0.5; 95% confidence interval 0.5-0.6; p < .0001) after adjustment for sex, age strata, race/ethnicity, hypertension, diabetes mellitus, nicotine dependence/tobacco use, hyperlipidemia, atrial fibrillation, congestive heart failure, long-term anticoagulant use, and alcohol abuse. The proportions of patients who developed pneumonia (58.4% versus 22.5%; p < .0001), acute kidney injury (48.7% versus 31.0%; p < .0001), acute myocardial infarction (11% versus 6.4%; p = .048), sepsis (41.6% versus 22.5%; p < .0001), and respiratory failure (61.7% versus 42.3%; p < .0001) were significantly higher among patients with intracerebral hemorrhage and COVID-19 compared with those without COVID-19. The in-hospital mortality among patients with intracerebral hemorrhage and COVID-19 was significantly higher compared with that among those without COVID-19 (40.3% versus 19.0%; p < .0001).ConclusionsOur analysis does not suggest that rates of intracerebral hemorrhage are higher in patients with COVID-19. The higher mortality in patients with intracerebral hemorrhage and COVID-19 compared with those without COVID-19 is likely mediated by higher frequency of comorbidities and adverse in-hospital events.

Project description:BackgroundIdentifying the cause of intracerebral hemorrhage (ICH) is relevant to optimize its management. We aimed to assess the applicability and utility of the Edinburgh CT criteria for cerebral amyloid angiopathy (CAA) in an unselected cohort of hospitalized patients.Patients and methodsWe retrospectively applied the Edinburgh criteria to the first available brain CTs of patients hospitalized for a first-ever lobar ICH in the district of L'Aquila from 2011 to 2017. ICH characteristics and outcomes were compared according to the presence of the Edinburgh CT criteria, including associated subarachnoid hemorrhage (aSAH) and finger-like projections (FLPs). The outcome of ICH in-hospital mortality was assessed with multivariate logistic regression analysis. We adopted the Edinburgh criteria, age, NIHSS and Glasgow Coma Scale scores, systolic blood pressure, antiplatelet treatment, ICH volume, and intraventricular extension on admission as covariates.ResultsOf 178 patients with lobar ICH, 52 (29.2%) had aSAH+FLPs, 60 (33.7%) aSAH only, 1 (0.6%) FLPs, and 65 (36.5%) none. Patients with aSAH+FLPs were older (79.0 ± 9.2 years) than those with only one criterion or none (74.0 ± 15.3 and 72.2 ± 13.8 years, respectively; P = 0.020). Patients with aSAH+FLPs also had more severe ICH at onset, higher in-hospital case-fatality (log rank test P = 0.003) and higher mRS scores at discharge (P < 0.001) as compared to those fulfilling one or none of the Edinburgh criteria. Low Glasgow Coma Scale score was the only factor independently associated to in-hospital case-fatality (odds ratio per point increase 0.51; 95% confidence interval, 0.32-0.91; P = 0.021).DiscussionOur data suggest the applicability of the Edinburgh CT criteria in a hospital setting. The presence of those criteria reflects ICH clinical severity.ConclusionsApplying the Edinburgh CT criteria might help refining the diagnosis and improving the management of patients with lobar ICH.

Dataset Information

Applicability of Clinical Trials in an Unselected Cohort of Patients With Intracerebral Hemorrhage.

Publications

Applicability of Clinical Trials in an Unselected Cohort of Patients With Intracerebral Hemorrhage.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets