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

Skane University Hospital

Status: Active, not recruiting

Conditions: Influenza; Trauma; Critical Illness; Covid19; Cardiac Arrest; Sepsis

Treatments: Diagnostic Test: Blood collection; Diagnostic Test: Blood collection, serial sampling

Study type: Observational

Funder types: Other

Identifiers

NCT04974775

SWECRIT

Details and patient eligibility

About

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.

Full description

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.

1. 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.
2. Assessment of neurological prognosis and outcomes will be a common denominator in several studies.
3. 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.

Enrollment: 8,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

8,500 participants in 7 patient groups

Critically Ill

Description:

Critically ill patients and patients in need of post-operative intensive care.

Treatment:

Diagnostic Test: Blood collection

Cardiac Arrest

Description:

Cardiac Arrest according to the ICD-10 I469 diagnosis.

Treatment:

Diagnostic Test: Blood collection, serial sampling

Diagnostic Test: Blood collection

Sepsis

Description:

Sepsis according to the sepsis-3 criteria.

Treatment:

Diagnostic Test: Blood collection

Covid-19

Description:

Critically ill patients with a positive Covid-19 test.

Treatment:

Diagnostic Test: Blood collection, serial sampling

Diagnostic Test: Blood collection

Influenza

Description:

Critically ill patients with a positive influenza test.

Treatment:

Diagnostic Test: Blood collection

Trauma

Description:

Critically ill patients after a severe traumatic event.

Treatment:

Diagnostic Test: Blood collection

Healthy controls

Description:

Healthy at the time of blood sampling

Treatment:

Diagnostic Test: Blood collection