NCT02073890

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2012

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 27, 2014

Completed
Last Updated

February 27, 2014

Status Verified

February 1, 2014

Enrollment Period

7 months

First QC Date

February 6, 2014

Last Update Submit

February 25, 2014

Conditions

Traumatic Subarachnoid Haemorrhage

Keywords

traumatic Subarachnoid HaemorrhageHead TraumaComputed Tomography

Outcome Measures

Primary Outcomes (1)

  • Level of consciousness measured by Glasgow coma scale

    Change from baseline to one month

Secondary Outcomes (1)

  • appearance of subarachnoid hemorrhage on CT measured by Fisher Grading

    Change from baseline to one month

Study Arms (1)

traumatic subarachnoid haemorrhage

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

traumatic subarachnoid haemorrhage

You may qualify if:

  • All patients of traumatic subarachnoid haemorrhage

You may not qualify if:

  • Metabolic disorder
  • Altered coagulation profile
  • Cardiac disease
  • Co- morbid illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Subarachnoid Hemorrhage, TraumaticCraniocerebral Trauma

Condition Hierarchy (Ancestors)

Intracranial Hemorrhage, TraumaticIntracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSubarachnoid HemorrhageTrauma, Nervous SystemCerebrovascular TraumaVascular DiseasesCardiovascular DiseasesWounds and Injuries

Study Officials

  • 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

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2014

First Posted

February 27, 2014

Study Start

September 1, 2012

Primary Completion

April 1, 2013

Study Completion

June 1, 2013

Last Updated

February 27, 2014

Record last verified: 2014-02