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

February 20, 2025 updated by: Tang Ziren

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients after successful cardiopulmonary resuscitation (CPR) were transferred to the emergency intensive care unit for further standardized management

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tang Ziren

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

September 30, 2024

First Submitted That Met QC Criteria

September 30, 2024

First Posted (Actual)

October 3, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 20, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-1-10-3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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