Investigate the Relationship Between Inflammatory and Coagulation in SAH CSF

Subarachnoid Hemorrhage, Aneurysmal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04938414
• Other study ID #: 2020-892
• Status: Completed
• Start date: December 1, 2020
• Est. completion date: October 1, 2021

Study information

• Verified date: June 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage
• Subarachnoid Hemorrhage, Aneurysmal

Intervention

Diagnostic Test:
• Lumbar puncture
Lumbar puncture to obtain the cerebrospinal fluid and for diagnostic test

Locations

Country	Name	City	State
China	Second affiliated hosipital of zhejiang univerisity 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	Length of hospital stay	Length of hospital stay	evaluated 1day after discharge
Primary	modified Rankin Scale	modified Rankin Scale (mRS) at discharge. mRS ranging from 0-5, higher represents worse	evaluated 1day after discharge
Primary	Glasgow Outcome Scale	Glasgow Outcome Scale (GOS) at discharge, GOS ranging from 0-5, higher represents better	evaluated 1day after discharge