Inflammation and Coagulation Factors for Predicting Cerebral Edema After SAH

August 22, 2023 updated by: Yuanjian Fang, Second Affiliated Hospital, School of Medicine, Zhejiang University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • Second Affiliated Hospital of Zhejiang University, School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral edema after subarachnoid hemorrhage
Time Frame: 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.
At 3 and 7days after SAH onset
Outcome at 3 months after subarachnoid hemorrhage
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

August 13, 2023

First Submitted That Met QC Criteria

August 22, 2023

First Posted (Actual)

August 24, 2023

Study Record Updates

Last Update Posted (Actual)

August 24, 2023

Last Update Submitted That Met QC Criteria

August 22, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-059

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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