| 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
|
|
|
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
|
|
|
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
|
|
|
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
|
|
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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. |