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NCT06009016 Clinical Trial

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
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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