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NCT Number: NCT06587763

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

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.

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Key information

Conditions

Cardiac Arrest, Out-Of-Hospital Brain Diseases Brain Injuries Cardiovascular Diseases Central Nervous System Diseases Craniocerebral Trauma Dementia Heart Arrest Heart Diseases Inflammation Mental Disorders Nervous System Diseases Neurocognitive Disorders Out-of-Hospital Cardiac Arrest Pathologic Processes Pathological Conditions, Signs and Symptoms Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Helsingborgs Hospital, Helsingborg, Sweden

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Functional outcome

    Time frame: 6 months

    Modified Rankin Scale 4-6

Secondary outcomes

  1. Neurocognitive outcomes

    Time frame: 6 months

    Montreal Cognitive Assessment

  2. Neurocognitive outcomes

    Time frame: 6 months

    Symbol Digit Modalities Test

Study contacts

Contact information is provided by the study sponsor or research team.

Marion Moseby-Knappe, MD, PhD

CONTACT

[email protected]

+46-46710000

Niklas Nielsen, Prof

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • Lund University
  • University of Helsinki

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2032
First posted
Sep 19, 2024
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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