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

NCT ID: NCT04974775

Last Updated: 2025-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

8500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2026-12-31

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.

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.

Conditions

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Critical Illness Cardiac Arrest Sepsis Influenza Covid19 Trauma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Critically Ill

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

Blood collection

Intervention Type DIAGNOSTIC_TEST

Sampling on admission to ICU (all patients)

Cardiac Arrest

Cardiac Arrest according to the ICD-10 I469 diagnosis.

Blood collection

Intervention Type DIAGNOSTIC_TEST

Sampling on admission to ICU (all patients)

Blood collection, serial sampling

Intervention Type DIAGNOSTIC_TEST

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.

Sepsis

Sepsis according to the sepsis-3 criteria.

Blood collection

Intervention Type DIAGNOSTIC_TEST

Sampling on admission to ICU (all patients)

Covid-19

Critically ill patients with a positive Covid-19 test.

Blood collection

Intervention Type DIAGNOSTIC_TEST

Sampling on admission to ICU (all patients)

Blood collection, serial sampling

Intervention Type DIAGNOSTIC_TEST

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.

Influenza

Critically ill patients with a positive influenza test.

Blood collection

Intervention Type DIAGNOSTIC_TEST

Sampling on admission to ICU (all patients)

Trauma

Critically ill patients after a severe traumatic event.

Blood collection

Intervention Type DIAGNOSTIC_TEST

Sampling on admission to ICU (all patients)

Healthy controls

Healthy at the time of blood sampling

Blood collection

Intervention Type DIAGNOSTIC_TEST

Sampling on admission to ICU (all patients)

Interventions

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Blood collection

Sampling on admission to ICU (all patients)

Intervention Type DIAGNOSTIC_TEST

Blood 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.

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Region Skane

OTHER

Sponsor Role collaborator

Lund University

OTHER

Sponsor Role collaborator

Skane University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hans Friberg

Professor, Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hans Friberg, MD, PhD

Role: STUDY_CHAIR

Skane University Hospital

Locations

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Helsingborg Hospital

Helsingborg, , Sweden

Site Status

Kristianstad Central Hospital

Kristianstad, , Sweden

Site Status

Skane University Hospital

Lund, , Sweden

Site Status

Skane University Hospital

Malmo, , Sweden

Site Status

Countries

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Sweden

References

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Lengquist M, Lundberg OHM, Spangfors M, Annborn M, Levin H, Friberg H, Frigyesi A. Sepsis is underreported in Swedish intensive care units: A retrospective observational multicentre study. Acta Anaesthesiol Scand. 2020 Sep;64(8):1167-1176. doi: 10.1111/aas.13647. Epub 2020 Jun 18.

Reference Type BACKGROUND
PMID: 32463121 (View on PubMed)

Lundberg OHM, Lengquist M, Spangfors M, Annborn M, Bergmann D, Schulte J, Levin H, Melander O, Frigyesi A, Friberg H. Circulating bioactive adrenomedullin as a marker of sepsis, septic shock and critical illness. Crit Care. 2020 Nov 4;24(1):636. doi: 10.1186/s13054-020-03351-1.

Reference Type BACKGROUND
PMID: 33148300 (View on PubMed)

Thorgeirsdottir B, Levin H, Spangfors M, Annborn M, Cronberg T, Nielsen N, Lybeck A, Friberg H, Frigyesi A. Plasma proenkephalin A 119-159 and dipeptidyl peptidase 3 on admission after cardiac arrest help predict long-term neurological outcome. Resuscitation. 2021 Jun;163:108-115. doi: 10.1016/j.resuscitation.2021.04.021. Epub 2021 Apr 27.

Reference Type BACKGROUND
PMID: 33930500 (View on PubMed)

Johnsson J, Bjornsson O, Andersson P, Jakobsson A, Cronberg T, Lilja G, Friberg H, Hassager C, Kjaergard J, Wise M, Nielsen N, Frigyesi A. Artificial neural networks improve early outcome prediction and risk classification in out-of-hospital cardiac arrest patients admitted to intensive care. Crit Care. 2020 Jul 30;24(1):474. doi: 10.1186/s13054-020-03103-1.

Reference Type BACKGROUND
PMID: 32731878 (View on PubMed)

Arctaedius I, Wasselius J, Lang M, Drake M, Johnsson M, Friberg H, Leithner C, Kenda M, Lybeck A, Moseby-Knappe M. The semi-quantitative cardiac arrest brain ischemia (CABI) score for magnetic resonance imaging predicts functional outcome after cardiac arrest. Crit Care. 2025 Aug 20;29(1):373. doi: 10.1186/s13054-025-05595-1.

Reference Type DERIVED
PMID: 40836345 (View on PubMed)

Didriksson I, Frigyesi A, Spangfors M, Leffler M, Reepalu A, Nilsson AC, Annborn M, Lybeck A, Friberg H, Lilja G. Long-term recovery in critically ill COVID-19 survivors: A prospective cohort study. Acta Anaesthesiol Scand. 2025 Jan;69(1):e14550. doi: 10.1111/aas.14550.

Reference Type DERIVED
PMID: 39540322 (View on PubMed)

Didriksson I, Lengquist M, Spangfors M, Leffler M, Sievert T, Lilja G, Frigyesi A, Friberg H, Schiopu A. Increasing plasma calprotectin (S100A8/A9) is associated with 12-month mortality and unfavourable functional outcome in critically ill COVID-19 patients. J Intensive Care. 2024 Jul 9;12(1):26. doi: 10.1186/s40560-024-00740-4.

Reference Type DERIVED
PMID: 38982551 (View on PubMed)

Arctaedius I, Levin H, Larsson M, Friberg H, Cronberg T, Nielsen N, Moseby-Knappe M, Lybeck A. 2021 European Resuscitation Council/European Society of Intensive Care Medicine Algorithm for Prognostication of Poor Neurological Outcome After Cardiac Arrest-Can Entry Criteria Be Broadened? Crit Care Med. 2024 Apr 1;52(4):531-541. doi: 10.1097/CCM.0000000000006113. Epub 2023 Dec 7.

Reference Type DERIVED
PMID: 38059722 (View on PubMed)

Other Identifiers

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SWECRIT

Identifier Type: -

Identifier Source: org_study_id

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