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

NCT06624488 | Recruiting DMC

• 1 other identifier: 2023-1-10-3
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrest (CA); Brain Injuries, Acute

Keywords

cardiac arrest; brain injury; cerebrospinal fluid; biomarkers

Outcome Measures

Primary Outcomes (1)

• Neurologic prognosis

  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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tang Ziren: lead

Study Sites (1)

Beijing chaoyang hospital

Beijing, 100020, China

RECRUITING

MeSH Terms

Conditions

Heart Arrest; Brain Injuries

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 3, 2024
• Study Start: January 1, 2023
• Primary Completion: April 1, 2025
• Study Completion: May 1, 2025
• Last Updated: February 21, 2025

Record last verified: 2025-02

Locations

CN (1)