Inflammation and Coagulation Factors for Predicting Cerebral Edema After SAH
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06009016
Collaborator
(none)
80
1
24
3.3
Study Details
Study Description
Brief Summary
Explore the role of Inflammation and coagulation factors in cerebrospinal fluid for predicting persistent cerebral edema after subarachnoid hemorrhage
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
80 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Inflammation and Coagulation Factors in Cerebrospinal Fluid for Predicting Persistent Cerebral Edema After Subarachnoid Hemorrhage
Actual Study Start Date
:
Aug 1, 2022
Anticipated Primary Completion Date
:
Aug 1, 2024
Anticipated Study Completion Date
:
Aug 1, 2024
Outcome Measures
Primary Outcome Measures
- Cerebral edema after subarachnoid hemorrhage [At 3 and 7days after SAH onset]
Cerebral edema after subarachnoid hemorrhage will be determined by the SEBES score. SEBES 0-2 is mild edema; SEBES 3-4 is severe edema.
- Outcome at 3 months after subarachnoid hemorrhage [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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Second affiliated hospital of Zhejiang University, School of Medicine | Hangzhou | Zhejiang | China | 310000 |
Sponsors and Collaborators
- Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Yuanjian Fang,
Second Affiliated Hospital, School of Medicine, Zhejiang University,
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT06009016
Other Study ID Numbers:
- 2023-059
First Posted:
Aug 24, 2023
Last Update Posted:
Aug 24, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: