Traumatic Subarachnoid HaemorrhageNCT02073890
Neurological Outcome in Patients of Traumatic Subarachnoid Haemorrhage
An observational study of Traumatic Subarachnoid Haemorrhage, run by Macmillan Research Group UK.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Traumatic Subarachnoid Haemorrhage
- How many people
- 117 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: traumatic subarachnoid haemorrhage
Who may be able to join
- All patients of traumatic subarachnoid haemorrhage
Who cannot join
- Metabolic disorder
- Altered coagulation profile
- Cardiac disease
- Co- morbid illness
About this study
Official title: Incidence and Outcomes of Traumatic Subarachnoid Haemorrhage Patients: A Cross Sectional Study
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.
- Conditions
- Traumatic Subarachnoid Haemorrhage
- Keywords
- traumatic Subarachnoid Haemorrhage, Head Trauma, Computed Tomography
- Medical subject headings
- Subarachnoid Hemorrhage, Traumatic, Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| traumatic subarachnoid haemorrhage | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of consciousness measured by Glasgow coma scale
Measured: Change from baseline to one month
Secondary outcomes (1)
appearance of subarachnoid hemorrhage on CT measured by Fisher Grading
Measured: Change from baseline to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study startSep 2012
- Primary completionApr 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Subarachnoid HaemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Macmillan Research Group UK
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Center for Applied Research & Education, SMS Medical College and Hospital
- Responsible party
- Sponsor
- Investigators
- Neha Sharma, PhD, Study chair, Macmillan Research Group UKVirendra D Sinha, M Ch, Study director, SMS Medical College & Hospital, JaipurManish Agrawal, M Ch, Principal investigator, SMS Medical College & Hospital, Jaipur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02073890
- Sponsor's protocol ID
- CARE 1021/14
- Status last verified
- Feb 2014
- First submitted
- 6 Feb 2014
- Last updated
- 27 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Outcomes of Traumatic Subarachnoid Haemorrhage Patients: A Cross Sectional Study
- ClinicalTrials.gov ID
- NCT02073890
- Acronym / sponsor ID
- CARE 1021/14
- Conditions
- Traumatic Subarachnoid Haemorrhage
- Keywords
- traumatic Subarachnoid Haemorrhage, Head Trauma, Computed Tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Macmillan Research Group UKIndustry (pharma, biotech, devices)
- Collaborators
- Center for Applied Research & Education, SMS Medical College and Hospital
- Study start
- Sep 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 27 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| traumatic subarachnoid haemorrhage | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- traumatic subarachnoid haemorrhage
Key inclusion criteria (1 listed)
- All patients of traumatic subarachnoid haemorrhage
Key exclusion criteria (4 listed)
- Metabolic disorder
- Altered coagulation profile
- Cardiac disease
- Co- morbid illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Level of consciousness measured by Glasgow coma scale
Time frame: Change from baseline to one month
1 secondary outcome
appearance of subarachnoid hemorrhage on CT measured by Fisher Grading
Time frame: Change from baseline to one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neha Sharma, PhD study chair
Macmillan Research Group UK
Virendra D Sinha, M Ch study director
SMS Medical College & Hospital, Jaipur
Manish Agrawal, M Ch principal investigator
SMS Medical College & Hospital, Jaipur
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Subarachnoid Haemorrhage, run by Macmillan Research Group UK.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of consciousness measured by Glasgow coma scale (time frame: Change from baseline to one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2014.