Investigate the Relationship Between Inflammatory and Coa... | NCT04938414

Studies
Investigate the Relationship Between Inflammatory and Coagulation in SAH CSF

NCT04938414

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Completed

Last Update Posted

Jan 6, 2022Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Subarachnoid Hemorrhage, Aneurysmal

Interventions

Lumbar puncture

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2020Actual

Primary Completion Date

Aug 1, 2021Actual

Completion Date

Oct 1, 2021Actual

First Submitted Date

Jun 21, 2021

First Submission Date that Met QC Criteria

Jun 23, 2021

First Posted Date

Jun 24, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 15, 2021

Last Update Posted Date

Jan 6, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
subarachnoid hemorrhage		Patients with subarachnoid hemorrhage	Diagnostic Test: Lumbar puncture
Control		patients with non-neurological diseases	Diagnostic Test: Lumbar puncture

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lumbar puncture	Diagnostic Test	Lumbar puncture to obtain the cerebrospinal fluid and for diagnostic test	Control subarachnoid hemorrhage

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with SAH

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yuanjian Fang, M.D	Zhejiang Univerisity	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Second affiliated hosipital of zhejiang univerisity school of medicine		Hangzhou	Zhejiang	310000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Mar 19, 2022
Reset	Jul 15, 2022

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Mar 19, 2022			Jul 15, 2022

Condition Browse Module

MeSH Terms

ID	Term
D013345	Subarachnoid Hemorrhage
D013927	Thrombosis
D007249	Inflammation

Ancestor Terms

ID	Term
D020300	Intracranial Hemorrhages
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013129	Spinal Puncture

Ancestor Terms

ID	Term
D001706	Biopsy
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided