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CTRI Number  CTRI/2025/03/082510 [Registered on: 17/03/2025] Trial Registered Prospectively
Last Modified On: 17/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Factors predicting outcome in patients with stroke 
Scientific Title of Study   Prediction Model for neurological outcome in patients with Aneurysmal SAH 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ikjot Singh 
Designation  Senior Resident 
Affiliation  PGIMER, Chandigarh 
Address  PGIMER, Madhya Marg Sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  08006120555  
Fax    
Email  singhikjot29@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Hemant Bhagat 
Designation  Professor 
Affiliation  PGIMER, Chandigarh 
Address  Department of Anaesthesia and Intensive care, PGIMER, Madhya Marg Sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  08006120555  
Fax    
Email  hembhagat@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ikjot Singh 
Designation  Senior Resident 
Affiliation  PGIMER, Chandigarh 
Address  PGIMER, Madhya Marg Sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  08006120555  
Fax    
Email  singhikjot29@gmail.com  
 
Source of Monetary or Material Support  
Department of Neuroanaesthesia, PGIMER, Madhya Marg Sector 12, Chandigarh Chandigarh CHANDIGARH 160012 India  
 
Primary Sponsor  
Name  Post Graduate Institute of Medical Education and Research 
Address  PGIMER, Madhya Marg Sector 12, Chandigarh Chandigarh CHANDIGARH 160012 India  
Type of Sponsor  Government medical college 
 
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 
PGIMER   Post Graduate Institute of Medical Education and Research, Chandigarh  Room number 20 Nehru hospital, Division of Neuro Anaesthesia and Neuro Critical Care Department of Anaesthesia and Critical Care , PGIMER Sector 12 Chandigarh
Chandigarh
CHANDIGARH 
8006120555

singhikjot29@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Postgraduate Institute of Medical Education and research, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I609||Nontraumatic subarachnoid hemorrhage, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NA  NA 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  The inclusion criteria for the study consisted of several key factors. Participants had to be aged 18 years or above and have radiologically confirmed aneurysmal subarachnoid hemorrhage. Additionally, patients undergoing surgical management for aneurysmal subarachnoid hemorrhage, including those undergoing surgical clipping or endovascular obliteration, were also included. Conversely, patients with aneurysmal subarachnoid hemorrhage who did not undergo clipping or endovascular procedures were excluded from the study. 
 
ExclusionCriteria 
Details  The study excluded patients who could not be scored on the Glasgow Coma Scale (GCS) upon admission, such as those who were intubated and under sedation before arriving at the central hospital. Additionally, patients who were lost to follow-up during the study period were also excluded. Furthermore, patients or their legal kin who withheld consent for participation in the study were not included. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
functional outcomes assessed using the Modified Rankin Scale (mRS) at discharge, 1 month, and 3 months, and the Glasgow Outcome Scale-Extended (GOSE) at 1 month and 3 months. Neurological status will be evaluated using the Glasgow Coma Scale (GCS) at discharge and any decline of 2 or more points during hospital stay. Mortality will be assessed based on in-hospital death and its cause.  enrollment, during hospitalization, and at discharge, with long-term functional recovery evaluated at 1 and 3 months post-ictus. 
 
Secondary Outcome  
Outcome  TimePoints 
complications, surgical details, biochemical and radiological parameters, hospital stay, long-term functional recovery, and patient demographics and risk factors.  enrollment, during hospitalization, and at discharge, with long-term functional recovery evaluated at 1 and 3 months post-ictus. 
 
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)   01/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/04/2025 
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  

Subarachnoid haemorrhage (SAH) is a type of stroke that mainly affects younger people with a mean age of 58 years. [1] Although the outcome has improved within the last decades, SAH still has an in-hospital mortality of 26%. [2] Roughly 25% of the variation in outcome for patients with SAH is explained by known risk factors including older age, worse neurological state on admission, severity of SAH on the initial computed tomography (CT)-scan, a history of hypertension and the size and position of the aneurysm in the posterior circulation. [3,4]

Outcome prediction in aneurysmal subarachnoid haemorrhage (SAH) has been attempted utilizing a variety of scoring systems. One-month mortality rate for aneurysmal SAH is around 40%, with the 6-month rates approaching 50–60%. The intention through past attempts was to reliably predict, by way of clinical status and neuroimaging, the risk of developing the serious complications and adverse outcomes associated with SAH. Complications such as vasospasm, shunt-dependent hydrocephalus, subendocardial ischemia, and neurogenic pulmonary edema are of primary interest. In addition, length of intensive care unit (ICU) stay, ventilator dependency, tracheostomy and gastrostomy status, discharge rates, and 1- and 6-month outcome prediction are desired. [5]

Clinical prediction models statistically combine a set of characteristics of the patient and disease to estimate the probability of an outcome. They can be useful decision support tools, assisting clinicians in the complex choices they make about patient management and, in turn, facilitating evidence informed discussions with the patient and family members around outcome expectations for shared decision making. According to some studies, outcome prediction tools can outperform clinical intuition in patients with stroke. Several prediction models and risk scores have been developed for patients with SAH, but their uptake into clinical practice is limited. The reasons might be related to the use of suboptimal study design and analysis in the development of these tools, the lack of representativeness, the ease of use in clinical setting, or the absence of evidence of their generalisability in different settings, as shown in a systematic review. Therefore, validated easy to use prediction tools are urgently needed to support the management of SAH. [7]

So, in this study we aim to identify the predictors of outcome according to Modified Rankin Scale (MRS) in patients of aneurysmal SAH. We will evaluate the preoperative, intraoperative and postoperative parameters in patients of aneurysmal SAH to develop and validate a model to assess the level of disability and mortality in these patients.


 
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