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Not yet recruiting NCT06587763

Late Biomarkers in Adult Survivors After Out-of-hospital Cardiac Arrest

Observational Cardiac Arrest, Out-Of-Hospital

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cardiac Arrest, Out-Of-Hospital. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Blood samples are collected at six months follow-up from adult survivors after out-of-hospital cardiac arrest. Patients will be informed about the study and if they consent to participation, venous blood will be drawn by authorised medical personnel. Plasma, serum and PAX-RNA will be collected (ca 15 ml in total), processed and frozen for analysis after trial completion.

Detailed description

Blood samples are collected at six months follow-up from adult survivors after out-of-hospital cardiac arrest. Patients will be informed about the study and if they consent to participation, venous blood will be drawn by authorised medical personnel. Plasma, serum and PAX-RNA will be collected (ca 15 ml in total), processed and frozen for analysis after trial completion.

Samples will be analysed in batch for biomarkers of brain injury, inflammation etc.

Primary outcome is functional outcome (modified Rankin Scale 4-6) at six months after cardiac arrest.

Secondary outcomes are neurocognitive function according to the Montreal Cognitive Assessment (MoCA), Symbol Digits Modalities Test (SDMT).

Primary outcome measures

  • Functional outcome [Time frame: 6 months]
Secondary outcome measures (2)
  • Neurocognitive outcomes [Time frame: 6 months]
  • Neurocognitive outcomes [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • Survivors of out-of-cardiac arrest who participate in the extended follow-up study of the STEPCARE trial at selected sites only

Exclusion criteria

  • Patients not participating in the extended follow-up at participating sites

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Sweden · 3 centers
  • Helsingborgs Hospital — Helsingborg
  • Skåne university hospital — Lund
  • Skåne University Hospital — Malmö

Identifiers

NCT: NCT06587763 · STEPCARE late biomarker study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗