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NCT Number: NCT06624488

The Relationship Between Brain Injury Biomarkers in Cerebrospinal Fluid and Blood of Patients After Cardiac Arrest and Prognosis

This study is a single-center, prospective, observational study. After successful cardiopulmonary resuscitation for patients with cardiac arrest, they will be transferred to the emergency intensive care unit for further standardized targeted temperature management. When evaluating that the patient meets the indications for lumbar puncture and there are no contraindications for lumbar puncture, lumbar puncture examinations will be completed immediately after return of spontaneous circulation (ROSC), at 24 hours of hypothermia, at 72 hours of hypothermia, and after rewarming. Routine cerebrospinal fluid examinations such as cerebrospinal fluid routine, cerebrospinal fluid biochemistry, and cerebrospinal fluid lactate will be sent for inspection. At the same time, 6 ml of cerebrospinal fluid will be retained and stored in a refrigerator at -80°C. After sample collection is completed, enzyme-linked immunosorbent assay (ELISA) will be used to detect markers such as NSE, HCH-L1, NFL, tau, MBP, GFAP, and S100β. While performing the lumbar puncture examination, peripheral blood will be collected. After centrifugation for 10 minutes (4000 revolutions), serum will be retained and stored in a refrigerator at -80°C to complete the examination of the above markers. After 3 months, the patient's neurological function prognosis will be followed up according to the Pittsburgh Cerebral Performance Category (CPC) scale.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years old.
  • Still lack of directive movements after restoration of spontaneous circulation through cardiopulmonary resuscitation.
  • Advanced life support and targeted temperature management are carried out within 6 hours after return of spontaneous circulation (ROSC).

Exclusion criteria

  • Patients with contraindications for lumbar puncture (severe cerebral edema indicated by brain imaging, disappearance of basal cisterns or occult intracranial mass lesions, receiving antiplatelet and anticoagulant therapy, and those with coagulation disorders).
  • Pregnant patients.
  • Patients with concomitant traumatic brain injury, stroke, cerebral hemorrhage and other diseases.
  • Patients whose families do not agree to be enrolled.

Treatment and study plan

Primary outcomes

  1. Neurologic prognosis

    Time frame: 3 months

    Patients will be followed up for neurologic prognosis according to the Pittsburgh Cerebral Performance Category (CPC) scale at 3 months after disease onset.The CPC score ranges from 1 to 5, with 1 indicating good performance, 2 indicating moderate disability, 3 indicating severe disability, 4 indicating vegetative state and 5 indicating brain death or death.

Sponsors and collaborators

Lead sponsor

Tang Ziren

Other

Registry information

Official study title

The Relationship Between Brain Injury Biomarkers in Cerebrospinal Fluid and Blood of Patients After Cardiac Arrest and Prognosis.

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 3, 2024
Registry last updated
Feb 21, 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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