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CTRI Number  CTRI/2024/06/068786 [Registered on: 12/06/2024] Trial Registered Prospectively
Last Modified On: 02/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   How does altered consciousness affect the neurological outcome of patients with aneurysmal subarachnoid haemorrhage ? 
Scientific Title of Study   Impact of altered consciousness at the time of presentation on the neurological outcome of patients with aneurysmal subarachnoid haemorrhage 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shreosee Das 
Designation  Senior Resident 
Affiliation  PGIMER 
Address  Department of Anaesthesiology and Critical Care, Division of Neuroanaesthesiology and Neuro Critical Care, Nehru Building, PGIMER.

Chandigarh
CHANDIGARH
160012
India 
Phone  8098842367  
Fax    
Email  shreosee36@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr.Shreosee Das 
Designation  DM Resident and researcher 
Affiliation  PGIMER 
Address  Department of Anaesthesiology and Critical Care, Division of Neuroanaesthesiology and Neuro Critical Care, Nehru Building, PGIMER.


CHANDIGARH
160012
India 
Phone  8098842367  
Fax    
Email  shreosee36@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shreosee Das 
Designation  Senior Resident 
Affiliation  PGIMER 
Address  Department of Anaesthesiology and Critical Care, Division of Neuroanaesthesiology and Neuro Critical Care, Nehru Building, PGIMER.


CHANDIGARH
160012
India 
Phone  8098842367  
Fax    
Email  shreosee36@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Post Graduate Institute of Medical Education and Research 
Address  PGIMER, Sector 12, Chandigarh. 160012 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shreosee Das  Department of Anaesthesiology and Critical Care  Department of Anaesthesiology and Critical Care 4003 4th floor A block Nehru Hospital PGIMER,Sector 12, Chandigarh. 160012
Chandigarh
CHANDIGARH 
8098842367

shreosee36@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Post Graduate Institute of Medical Education and Research Chandigarh Institute Ethics Committee (Intramural)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I601||Nontraumatic subarachnoid hemorrhage from middle cerebral artery, (2) ICD-10 Condition: I602||Nontraumatic subarachnoid hemorrhage from anterior communicating artery, (3) ICD-10 Condition: I603||Nontraumatic subarachnoid hemorrhage from posterior communicating artery, (4) ICD-10 Condition: I604||Nontraumatic subarachnoid hemorrhage from basilar artery, (5) ICD-10 Condition: I606||Nontraumatic subarachnoid hemorrhage from other intracranial arteries, (6) ICD-10 Condition: I607||Nontraumatic subarachnoid hemorrhage from unspecified intracranial artery, (7) ICD-10 Condition: I600||Nontraumatic subarachnoid hemorrhage from carotid siphon and bifurcation, (8) ICD-10 Condition: I608||Other nontraumatic subarachnoid hemorrhage, (9) ICD-10 Condition: I605||Nontraumatic subarachnoid hemorrhage from vertebral artery, (10) ICD-10 Condition: I609||Nontraumatic subarachnoid hemorrhage, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Age 18 years and above
Radiological confirmed aneurysmal subarachnoid haemorrhage
Patients with aneurysmal subarachnoid haemorrhage undergoing surgical clipping/ endovascular obliteration
Patients with aneurysmal subarachnoid haemorrhage not undergoing clipping/endovascular procedure
 
 
ExclusionCriteria 
Details  Consent withheld by patient or patient’s legal kin
Patient less than 18 years of age
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the impact of Glasgow Coma Score post resuscitation on the neurological outcome of patients with aneurysmal subarachnoid haemorrhage  3 months from event 
 
Secondary Outcome  
Outcome  TimePoints 
To study & compare the impact of altered consciousness using 3 different scales on patients with aneurysmal subarachnoid haemorrhage
To study the impact of altered consciousness on the neurological outcome of patients with aneurysmal subarachnoid haemorrhage
 
At discharge & at one month following the event 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   23/06/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Cerebral aneurysms are defined as dilations that occur at weak points along the arterial circulation within the brain. Around 85% of aneurysms are located in the anterior circulation, predominately at junctions or bifurcations along the circle of Willis. Rupture of these aneurysms cause subarachnoid haemorrhage.1

In India, the prevalence of intracranial aneurysm ranges from 0.75% to 10.3%.2

 

Patients with high white blood cell count, multiple aneurysms, hypertension, GCS<9, GCS 9-12, modified Fisher grade 3 and 4 and Hunt-Hess grade 3 or more were found to have poor prognosis.3 Cardiac complications associated with aneurysmal subarachnoid haemorrhage include arrhythmia, myocardial infarction and even cardiac arrest. aSAH is also associated with pulmonary oedema, acute respiratory distress, septicaemia and acute renal failure. Rebleeding, delayed cerebral ischemia, seizures and hydrocephalus are examples of neurological complications.4

Reduced alertness, diminished wakefulness, and a decreased awareness of oneself and the environment all characterize impaired consciousness.5 After being admitted, none of the patients with a GCS motor score of 3 or less than 3 were still alive at 12 months according to a single centre retrospective study.6Sodhi et al in their study reported that WFNS grade at presentation as the most important predictor of outcome.7Chiang et al found that the patient’s worst clinical grade is most predictive of outcome, especially when the patient is assessed using the WFNS scale or the GCS.8 There are very few studies from India that have looked into the overall prognosis of aSAH patients especially those with altered consciousness. We hypothesize that patients with aneurysmal subarachnoid haemorrhagepresenting with altered consciousness at the time of hospital admission will have poor neurological outcome as compared to those with preservation of consciousness.


 

Hypothesis of the study

Patients with aneurysmal subarachnoid haemorrhage presenting with altered consciousness at the time of hospital admission will have poor neurological outcome as compared to those with preserved consciousness.

 
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