Swecrit Biobank - Blood Samples From Critically Ill Patients and Healthy Controls

Study Overview
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Brief Summary
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Blood samples are collected and stored in a biobank for later analysis of circulating substances in peripheral blood and genetic variations in patients with severe critical illness and risk of death. The aim is to analyze stored samples in order to identify substances that can help predict the outcome of critically ill patients, but also to optimize treatment and possibly prevent serious illness and death in the future.

Detailed Description
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SWECRIT is a regional, multicenter study with prospective collection of blood samples and background information from critically ill patients, admitted to an Intensive Care Unit (ICU) in Region Skåne, Sweden. Patients were originally categorized into four study cohorts a) cardiac arrest, b) sepsis, c) influenza, and d) trauma. In April of 2020, a fifth study cohort, covid19, was added to the original ones. In addition, a control group of healthy controls has been enrolled. Diagnoses, disease course, treatment results and survival are prospectively collected from all critically ill patients in the Patient Administrative System for Intensive Care Units (PASIVA). PASIVA is the portal by which collected laboratory and physiological data are entered into the Swedish Intensive Care Register (SIR). Further data are collected retrospectively from other health-related registers, such as the Swedish Population Register, the International Cardiac Arrest Registry (INTCAR), The Swedish CPR Registry, the Swedish Trauma Registry (SweTrau), and the Regional quality register Covid-IR (covid19 disease). Specifically for the covid19-cohort, detailed face-to-face follow-up will be performed of all survivors at 3 & 12 months and a telephone interview after 3 years. Questionnaires (see below) will be sent to patients prior to the follow-up. Questions about well-being in general, quality-of-life, sleeping disorders, psychological and psychiatric problems will be addressed. Collected blood samples in the ICU are processed by clinical chemistry at each participating hospital and frozen specimens of whole blood, serum, and plasma (200 ul aliquots) are sent to the biobank BD-47 in Region Skane for long-term storage (maximum 20 years). The circulating substances and genetic markers, i.e. biomarkers that will be analyzed are: proteins (markers of inflammation, stress, infection, neurologic injury, myocardial injury and endothelial function) and other circulating substances in the blood (metabolomics), genes (DNA) from the entire genome, epigenetic changes (eg methylation status of DNA), gene fragments (eg secretory DNA), various forms of RNA such as micro-RNA & longcoding RNA. Research questions for future analyzes of collected samples are specified but subject to change, depending on progress and development in the specific research field of each study cohort. Identification and use of biomarkers for assessment of severity of disease and trajectory over time in the ICU will be the main area of research. Assessment of neurological prognosis and outcomes will be a common denominator in several studies. Descriptive statistics and regression analyses will be performed in order to identify independent variables (biomarkers) of importance for prognosis and outcomes. Inquiries to access the sample collection for research purpose can be sent to the central contacts listed below.

Official Title
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Swecrit Biobank - Blood Samples From Critically Ill Patients and Healthy Controls

Conditions
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Critical Illness, Cardiac Arrest, Sepsis, Influenza, Covid19, Trauma

Intervention / Treatment
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* Diagnostic Test: Blood collection
* Diagnostic Test: Blood collection, serial sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Critically ill patients admitted to the ICU 18 years or older covid19-verified (covid19-cohort) Exclusion Criteria: The patient or next of kin decline participation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Critically Ill<br>Critically ill patients and patients in need of post-operative intensive care. | Diagnostic Test: Blood collection<br>* Sampling on admission to ICU (all patients)<br>|
| Cardiac Arrest<br>Cardiac Arrest according to the ICD-10 I469 diagnosis. | Diagnostic Test: Blood collection<br>* Sampling on admission to ICU (all patients)<br>Diagnostic Test: Blood collection, serial sampling<br>* Additional sampling to admission samples in the Cardiac Arrest group after 12 and 48 hours the Covid-19 group on day 2 and 7 while in the ICU the Covid-19 group after 3 and 12 months.<br>|
| Sepsis<br>Sepsis according to the sepsis-3 criteria. | Diagnostic Test: Blood collection<br>* Sampling on admission to ICU (all patients)<br>|
| Covid-19<br>Critically ill patients with a positive Covid-19 test. | Diagnostic Test: Blood collection<br>* Sampling on admission to ICU (all patients)<br>Diagnostic Test: Blood collection, serial sampling<br>* Additional sampling to admission samples in the Cardiac Arrest group after 12 and 48 hours the Covid-19 group on day 2 and 7 while in the ICU the Covid-19 group after 3 and 12 months.<br>|
| Influenza<br>Critically ill patients with a positive influenza test. | Diagnostic Test: Blood collection<br>* Sampling on admission to ICU (all patients)<br>|
| Trauma<br>Critically ill patients after a severe traumatic event. | Diagnostic Test: Blood collection<br>* Sampling on admission to ICU (all patients)<br>|
| Healthy controls<br>Healthy at the time of blood sampling | Diagnostic Test: Blood collection<br>* Sampling on admission to ICU (all patients)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality (all) | Primary outcome when functional outcome cannot be assessed. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with good neurological outcome 1 (all) | Neurological outcome assessed using Cerebral Performance Category 1-5 (CPC 1-5), CPC 1 representing the best and CPC 5 the worst outcome. Good outcome is defined as CPC 1-2, poor outcome as CPC 3-5. | 3-6 months | 
| Proportion of patients with good neurological outcome 2 (all) | Modified Rankin Score 0-6 (mRS 0-6), mRS 0 representing the best and mRS 6 representing the worst outcome. Good outcome is defined as mRS 0-3, poor outcome as mRS 3-6. | 3-6 months | 
| Neurological outcome 3 (covid19) | Glasgow Outcome Scale Extended 1-8 (GOSE 1-8), GOSE 1 representing the worst outcome and GOSE 8 the best outcome. | 3-6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biobank, Critical Illness, Cardiac Arrest, Sepsis, Influenza, Covid-19, Trauma, Prognosis, Neurology