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Clinical Trials/NCT06624488
NCT06624488
Recruiting
Not Applicable

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

Tang Ziren1 site in 1 country30 target enrollmentJanuary 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Arrest (CA)
Sponsor
Tang Ziren
Enrollment
30
Locations
1
Primary Endpoint
Neurologic prognosis
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2023
End Date
May 1, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Tang Ziren
Responsible Party
Sponsor Investigator
Principal Investigator

Tang Ziren

Professor

Capital Medical University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Study Sites (1)

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