Investigate the Relationship Between Inflammatory and Coagulation in SAH CSF

December 15, 2021 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

Inhibition of Caspase-1 Reduces Pyroptotic Neuroinflammation and Tissue Factor-Induced Cerebrospinal Fluid Circulation Impairment After Subarachnoid Hemorrhage

Investigate the role of inflammasome and blood coagulation response in human cerebrospinal fluid after subarachnoid hemorrhage.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Investigate the role of inflammasome and blood coagulation response in human cerebrospinal fluid after subarachnoid hemorrhage (SAH).

1.40 patients with SAH will be included. The CSF will used for ELISA test for inflammatory factors and cogulation factors.

2.CSF obtained from 4 patients with non-neuroloogical disease with 4 addittional SAH patients will be used for Mass Spectrometry

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

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

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Second affiliated hosipital of zhejiang univerisity school of medicine

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

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with SAH

Description

Inclusion Criteria:

  • SAH patients with modified Fisher Scale 3-4.

Exclusion Criteria:

  • Patients with history of CNS disease (e.g., stroke, traumatic brain injury, CNS infection) or accompanied by serious comorbidities before SAH onset (e.g., severe coagulation disorders, malignant tumor, uncontrollable heart disease, and hypertension) or other organ dysfunctions within 6 months were excluded from the study

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
subarachnoid hemorrhage
Patients with subarachnoid hemorrhage
Diagnostic test: Lumbar puncture
Lumbar puncture to obtain the cerebrospinal fluid and for diagnostic test
Control
patients with non-neurological diseases
Diagnostic test: Lumbar puncture
Lumbar puncture to obtain the cerebrospinal fluid and for diagnostic test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: evaluated 1day after discharge
Length of hospital stay
evaluated 1day after discharge
modified Rankin Scale
Time Frame: evaluated 1day after discharge
modified Rankin Scale (mRS) at discharge. mRS ranging from 0-5, higher represents worse
evaluated 1day after discharge
Glasgow Outcome Scale
Time Frame: evaluated 1day after discharge
Glasgow Outcome Scale (GOS) at discharge, GOS ranging from 0-5, higher represents better
evaluated 1day after discharge

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

Investigators

  • Study Chair: Yuanjian Fang, M.D, Zhejiang Univerisity

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)

December 1, 2020

Primary Completion (Actual)

August 1, 2021

Study Completion (Actual)

October 1, 2021

Study Registration Dates

First Submitted

June 21, 2021

First Submitted That Met QC Criteria

June 23, 2021

First Posted (Actual)

June 24, 2021

Study Record Updates

Last Update Posted (Actual)

January 6, 2022

Last Update Submitted That Met QC Criteria

December 15, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-892

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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