| 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
|
|
|
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
|
|
|
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. |