Inflammation and Coagulation Factors for Predicting Cerebral Edema After SAH

Inflammation Clinical Trial

Official title:

Inflammation and Coagulation Factors in Cerebrospinal Fluid for Predicting Persistent Cerebral Edema After Subarachnoid Hemorrhage

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06009016
• Other study ID #: 2023-059
• Status: Recruiting
• Start date: August 1, 2022
• Est. completion date: August 1, 2024

Study information

• Verified date: August 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Yuanjian Fang, M.D
• Phone: 86-18768109541
• Email: sandman0506[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Brain Edema
• Cerebral Edema
• Coagulation and Hemorrhagic Disorders
• Edema
• Hemorrhagic Disorders
• Inflammation

Intervention

Diagnostic Test:
• Inflammatory factors and coagulation factors level in cerebrospinal fluid after subarachnoid hemorrhage
Inflammatory factors and coagulation factors level in cerebrospinal fluid will be tested by ELISA kits.

Locations

Country	Name	City	State
China	Second affiliated hospital of Zhejiang University, School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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