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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04974775
Acronym
SWECRIT
Enrollment
8500
Registered
2021-07-23
Start date
2014-06-30
Completion date
2026-12-31
Last updated
2025-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Biobank, Critical Illness, Cardiac Arrest, Sepsis, Influenza, Covid-19, Trauma, Prognosis, Neurology

Brief summary

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

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.

Interventions

DIAGNOSTIC_TESTBlood collection

Sampling on admission to ICU (all patients)

DIAGNOSTIC_TESTBlood collection, serial sampling

Additional sampling to admission samples in 1. the Cardiac Arrest group after 12 and 48 hours 2. the Covid-19 group on day 2 and 7 while in the ICU 3. the Covid-19 group after 3 and 12 months.

Sponsors

Region Skane
CollaboratorOTHER
Lund University
CollaboratorOTHER
Skane University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Mortality (all)6 monthsPrimary outcome when functional outcome cannot be assessed.

Secondary

MeasureTime frameDescription
Proportion of patients with good neurological outcome 1 (all)3-6 monthsNeurological 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.
Proportion of patients with good neurological outcome 2 (all)3-6 monthsModified 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.
Neurological outcome 3 (covid19)3-6 monthsGlasgow Outcome Scale Extended 1-8 (GOSE 1-8), GOSE 1 representing the worst outcome and GOSE 8 the best outcome.

Other

MeasureTime frameDescription
Proportion of patients with significant Fatigue (covid19)3, 12 and 36 monthsModified fatigue impact scale 0-84 (MFIS 0-84), higher values representing more fatigue and lower numbers representing less fatigue. A value \>38 discriminates significant fatigue.
Severity of the Acute Respiratory Distress Syndrome (ARDS) (covid19)On ICU admissionPatients fulfilling the ARDS criteria are categorized into mild, moderate or severe, depending on the ratio of arterial oxygen partial pressure (mmHg) to fractional inspired oxygen (FiO2). Mild: \< 300, Moderate: \< 200, Severe: \< 100.
Hospital Anxiety and Depression Scale (covid19)3, 12 and 36 monthsAnxiety and depression. Two sub-scales with 7 items in each, higher values represent more anxiety and depression, \>8 points in each sub-scale indicates significant symptoms of anxiety and depression.
Proportion of patients with pathological Pulmonary Function Testing (PFT)3 and 12 monthsA composite of Total Lung Capacity (TLC) & Diffusion capacity (DLCO) compared to a population norm. Less than 80 % of the (age-adjusted) population norm is considered pathological.
Subjective respiratory function (covid19)3, 12 and 36 monthsSaint George's Respiratory Questionnaire 0-100 (SGRQ 0-100), lower values representing better function and higher values representing worse function. 8.41 (SD 11.33) is considered a normative value (Spanish population).
Physical problems (covid19)3, 12 and 36 monthsShort form Health Survey, version 2, physical function 10 (SF-36 v.2 PF-10), 10 items, higher score for each item represents better function. Scores are transformed to T-scores based on norm-based values. A T-score of 50 indicates the norm mean for each item. At a group level scores \<47 and individual scores \<45 indicate low physical function.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026