Neurological Outcome in Patients of Traumatic Subarachnoi... | NCT02073890

Studies
Neurological Outcome in Patients of Traumatic Subarachnoid Haemorrhage

NCT02073890

Sponsor

Macmillan Research Group UK

Status

Completed

Last Update Posted

Feb 27, 2014Estimated

Enrollment

117Actual

Phase

Not provided

Conditions

Traumatic Subarachnoid Haemorrhage

Interventions

Not provided

Countries

Not provided

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2014

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

Sep 2012

Primary Completion Date

Apr 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

Feb 6, 2014

First Submission Date that Met QC Criteria

Feb 25, 2014

First Posted Date

Feb 27, 2014Estimated

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

Feb 25, 2014

Last Update Posted Date

Feb 27, 2014Estimated

Name	Class
Center for Applied Research & Education	UNKNOWN
SMS Medical College and Hospital	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Traumatic brain injury is common cause of morbidity and mortality worldwide. Incidence and pattern of traumatic brain injury varies in developed and developing countries. Subarachnoid haemorrhage refers to blood in subarachnoid space that lies between arachnoid and piameninges, covering brain. It is often associated with concurrent intracranial injury component. Individuals at higher risk for tSAH are those who are at higher risk for blunt head trauma. This includes adolescents, low-income individuals, men, and individuals with a history of substance abuse. The investigators present study aims to investigate prognostic factors associated with the neurological outcome among patients of post traumatic SAH.

Detailed Description

Not provided

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

117Actual

Label	Type	Description	Intervention Names
traumatic subarachnoid haemorrhage

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Level of consciousness measured by Glasgow coma scale		Change from baseline to one month

Secondary Outcomes

Measure	Description	Time Frame
appearance of subarachnoid hemorrhage on CT measured by Fisher Grading		Change from baseline to one month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients of traumatic subarachnoid haemorrhage

Exclusion Criteria:

Metabolic disorder
Altered coagulation profile
Cardiac disease
Co- morbid illness

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

traumatic subarachnoid haemorrhage

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Neha Sharma, PhD	Macmillan Research Group UK	Study Chair
Virendra D Sinha, M Ch	SMS Medical College & Hospital, Jaipur	Study Director
Manish Agrawal, M Ch	SMS Medical College & Hospital, Jaipur	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020206	Subarachnoid Hemorrhage, Traumatic
D006259	Craniocerebral Trauma

Ancestor Terms

ID	Term
D020198	Intracranial Hemorrhage, Traumatic
D020300	Intracranial Hemorrhages
D002561	Cerebrovascular Disorders
D001927	Brain Diseases

Browse Leaves

Not provided

Browse Branches

Not provided