Biospecimens and Molecular and Cellular Biomarkers in Aneurysmal Subarachnoid Hemorrhage Studies: Common Data Elements and Standard Reporting Recommendations

Chou, Sherry; Macdonald, R. Loch; Keller, Emanuela

doi:10.1007/s12028-019-00725-4

Cited by 32 publications

(23 citation statements)

References 91 publications

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“…Furthermore, our study complies with the recent reporting recommendations in cellular and molecular SAH studies using recommended methods of sample acquisition, use of collection tubes, biospecimen processing and storage, inclusion of a neurologically healthy control group for both CSF and plasma, as well as using functional outcome and DCI as outcome measures [42]. This way, we hope to contribute to increased homogeneity across studies, which is essential for future biomarker validation to improve risk prediction and optimize treatment.…”

Section: Discussionmentioning

confidence: 60%

“…Finally, this is still a novel investigation field in which our exploratory and retrospective study design was not able to include all potential laboratory and clinical confounders, which may alter LCP profiles in plasma and CSF. Future studies should investigate comorbidities, in particular on-going inflammatory/infectious diseases, neoplastic, paraneoplastic and demyelinating conditions, premorbid hypertension as stated in recent recommendations as well as other potential confounders [42,47].…”

Section: Discussionmentioning

confidence: 99%

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Lectin complement pathway initiators after subarachnoid hemorrhage — an observational study

Matzen

Krogh

Forman

et al. 2020

J Neuroinflammation

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Background This exploratory study investigated the time-course of lectin complement pathway (LCP) initiators in cerebrospinal fluid (CSF) and plasma in patients with subarachnoid hemorrhage (SAH), as well as their relationship to delayed cerebral ischemia (DCI) and functional outcome. Methods Concentrations of ficolin-1, ficolin-2, ficolin-3, and mannose-binding lectin (MBL) were analyzed in CSF and plasma from patients with SAH. Samples were collected daily from admission until day 9 (CSF; N_PATIENTS = 63, n_SAMPLES = 399) and day 8 (plasma; N_PATIENTS = 50, n_SAMPLES = 358), respectively. Twelve neurologically healthy patients undergoing spinal anesthesia and 12 healthy blood donors served as controls. The development of DCI during hospitalization and functional outcome at 3 months (modified Rankin Scale) were registered for patients. Results On admission, CSF levels of all LCP initiators were increased in SAH patients compared with healthy controls. Levels declined gradually over days in patients; however, a biphasic course was observed for ficolin-1. Increased CSF levels of all LCP initiators were associated with a poor functional outcome in univariate analyses. This relationship persisted for ficolin-1 and MBL in multivariate analysis after adjustments for confounders (age, sex, clinical severity, distribution and amount of blood on CT-imaging) and multiple testing (1.87 ng/mL higher in average, 95% CI, 1.17 to 2.99 and 1.69 ng/mL higher in average, 95% CI, 1.09 to 2.63, respectively). In patients who developed DCI compared with those without DCI, CSF levels of ficolin-1 and MBL tended to increase slightly more over time (p_interaction = 0.021 and 0.033, respectively); however, no association was found after adjustments for confounders and multiple testing (p-adj_interaction = 0.086 and 0.098, respectively). Plasma ficolin-1 and ficolin-3 were lower in SAH patients compared with healthy controls on all days. DCI and functional outcome were not associated with LCP initiator levels in plasma. Conclusion Patients with SAH displayed elevated CSF levels of ficolin-1, ficolin-2, ficolin-3, and MBL. Increased CSF levels of ficolin-1 and MBL were associated with a poor functional outcome. Trial registration This study was a retrospective analysis of samples, which had been prospectively sampled and stored in a biobank. Registered at clinicaltrials.gov (NCT01791257, February 13, 2013, and NCT02320539, December 19, 2014).

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Section: Discussionmentioning

confidence: 60%

Section: Discussionmentioning

confidence: 99%

Lectin complement pathway initiators after subarachnoid hemorrhage — an observational study

Matzen

Krogh

Forman

et al. 2020

J Neuroinflammation

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“…The National Institute of Neurological Disease and Stroke (NINDS) has developed and catalogued consensus CDEs across many important neurological conditions including stroke, subarachnoid hemorrhage, and traumatic brain injury [37][38][39]. CDE development for COVID-19 neurological dysfunction will follow the guidelines set forth by the NINDS CDE project [36,37,[40][41][42][43] [44]. Tier 1 CDE includes patient sex, age, race/ethnicity, presence of comorbidities, neurological symptoms and syndromes, admission laboratory values, radiographic findings, pharmacological treatments and hospital outcomes including death, discharge disposition, and length of stay.…”

Section: Common Data Elementsmentioning

confidence: 99%

Global Consortium Study of Neurological Dysfunction in COVID-19 (GCS-NeuroCOVID): Study Design and Rationale

et al. 2020

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Background: As the COVID-19 pandemic developed, reports of neurological dysfunctions spanning the central and peripheral nervous systems have emerged. The spectrum of acute neurological dysfunctions may implicate direct viral invasion, para-infectious complications, neurological manifestations of systemic diseases, or co-incident neurological dysfunction in the context of high SARS-CoV-2 prevalence. A rapid and pragmatic approach to understanding the prevalence, phenotypes, pathophysiology and prognostic implications of COVID-19 neurological syndromes is urgently needed. Methods: The Global Consortium to Study Neurological dysfunction in COVID-19 (GCS-NeuroCOVID), endorsed by the Neurocritical Care Society (NCS), was rapidly established to address this need in a tiered approach. Tier-1 consists of focused, pragmatic, low-cost, observational common data element (CDE) collection, which can be launched immediately at many sites in the first phase of this pandemic and is designed for expedited ethical board review with waiver-of-consent. Tier 2 consists of prospective functional and cognitive outcomes assessments with more detailed clinical, laboratory and radiographic data collection that would require informed consent. Tier 3 overlays Tiers 1 and 2 with experimental molecular, electrophysiology, pathology and imaging studies with longitudinal outcomes assessment and would require centers with specific resources. A multicenter pediatrics core has developed and launched a parallel study focusing on patients ages <18 years. Study sites are eligible for participation if they provide clinical care to COVID-19 patients and are able to conduct patient-oriented research under approval of an internal or global ethics committee. Hospitalized pediatric and adult patients with SARS-CoV-2 and with acute neurological signs or symptoms are eligible to participate. The primary study outcome is the overall prevalence of neurological complications among hospitalized COVID-19 patients, which will be calculated by pooled estimates of each neurological finding divided by the average census of COVID-19 positive patients over the study period. Secondary outcomes include: in-hospital, 30 and 90-day morality, discharge modified Rankin score, ventilator-free survival, ventilator days, discharge disposition, and hospital length of stay.

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“…Neuroprotective agents thus far have failed to effectively translate to clinical application, but appropriately selected biomarkers may revive this effort [13]. Because of these challenges, any proposed biomarker would need to be cross-validated [21].…”

Section: Challenges In Biomarker Utilizationmentioning

confidence: 99%

Biomarker Application for Precision Medicine in Stroke

Simpkins

Janowski

et al. 2019

Transl. Stroke Res.

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Stroke remains one of the leading causes of long-term disability and mortality despite recent advances in acute thrombolytic therapies. In fact, the global lifetime risk of stroke in adults over the age of 25 is approximately 25%, with 24.9 million cases of ischemic stroke and 18.7 million cases of hemorrhagic stroke reported in 2015. One of the main challenges in developing effective new acute therapeutics and enhanced long-term interventions for stroke recovery is the heterogeneity of stroke, including etiology, comorbidities, and lifestyle factors that uniquely affect each individual stroke survivor. In this comprehensive review, we propose that future biomarker studies can be designed to support precision medicine therapeutic interventions after stroke. The current challenges in defining ideal biomarkers for stroke are highlighted, including consideration of disease course, age, lifestyle factors, and subtypes of stroke. This overview of current clinical trials includes biomarker collection, and concludes with an example of biomarker design for aneurysmal subarachnoid hemorrhage. With the advent of "-omics" studies, neuroimaging, big data, and precision medicine, well-designed stroke biomarker trials will greatly advance the treatment of a disease that affects millions globally every year.

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Biospecimens and Molecular and Cellular Biomarkers in Aneurysmal Subarachnoid Hemorrhage Studies: Common Data Elements and Standard Reporting Recommendations

Cited by 32 publications

References 91 publications

Lectin complement pathway initiators after subarachnoid hemorrhage — an observational study

Lectin complement pathway initiators after subarachnoid hemorrhage — an observational study

Global Consortium Study of Neurological Dysfunction in COVID-19 (GCS-NeuroCOVID): Study Design and Rationale

Biomarker Application for Precision Medicine in Stroke

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