Inflammation and Coagulation Factors for Predicting Cerebral Edema After SAH

NCT06009016 | Unknown

• 1 other identifier: 2023-059
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Explore the role of Inflammation and coagulation factors in cerebrospinal fluid for predicting persistent cerebral edema after subarachnoid hemorrhage

Conditions

Inflammation; Coagulation and Hemorrhagic Disorders; Cerebral Edema

Outcome Measures

Primary Outcomes (2)

• Cerebral edema after subarachnoid hemorrhage

  Cerebral edema after subarachnoid hemorrhage will be determined by the SEBES score. SEBES 0-2 is mild edema; SEBES 3-4 is severe edema.

  At 3 and 7days after SAH onset

• Outcome at 3 months after subarachnoid hemorrhage

  Outcome will be determined by the modified Rankin Score (mRS). mRS 0-2 is favorable outcome; mRS3-5 is poor outcome.

  3 months after subarachnoid hemorrhage

Interventions

Inflammatory factors and coagulation factors level in cerebrospinal fluid after subarachnoid hemorrhage DIAGNOSTIC_TEST

Inflammatory factors and coagulation factors level in cerebrospinal fluid will be tested by ELISA kits.

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subarachnoid hemorrhage patients admitted to our neurosurgery department with modified Fisher Scale 3-4, with a confirmed radiographic diagnosis. Age range from 20-80.

You may qualify if:

• Subarachnoid hemorrhage patients admitted to our neurosurgery department with modified Fisher Scale 3-4, with a confirmed radiographic diagnosis.

You may not qualify if:

• Angiogram-negative patients, patients with a history of trauma or previous brain injury (stroke, hemorrhage, surgery et al. which left associated chronic changes on CT), arteriovenous malformation, radiological data lost, accompany with serious comorbidities before subarachnoid hemorrhage onset (such as coagulation defects, uncontrollable hypertension, and arrhythmia et.al.), initial radiological data performed more than 3 days after SAH onset

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second affiliated hospital of Zhejiang University, School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Inflammation; Thrombosis; Hemorrhagic Disorders; Brain Edema

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Yuanjian Fang, M.D

CONTACT

86-18768109541; sandman0506@zju.edu.cn

Sheng Chen, M.D

CONTACT

86-13645814323; saintchan@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Record Dates

• First Submitted: August 13, 2023
• First Posted: August 24, 2023
• Study Start: August 1, 2022
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 24, 2023

Record last verified: 2023-08

Locations

CN (1)