| CTRI Number |
CTRI/2025/03/082356 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
09/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of Aspirin in patients with aneurysmal subarachnoid haemorrhage
|
|
Scientific Title of Study
|
Effects of Aspirin on postoperative cerebral vasospasm and delayed cerebral ischemia in aneurysmal subarachnoid haemorrhage A prospective, randomized, single-blinded pilot trial
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Advait Pakhmode |
| Designation |
Junior Resident |
| Affiliation |
AIIMS jodhpur |
| Address |
Department of Neurosurgery, AIIMS Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9511699859 |
| Fax |
|
| Email |
advaitpakhmode17007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Advait Pakhmode |
| Designation |
Junior Resident |
| Affiliation |
AIIMS jodhpur |
| Address |
Department of Neurosurgery, AIIMS Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9511699859 |
| Fax |
|
| Email |
advaitpakhmode17007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Advait Pakhmode |
| Designation |
Junior Resident |
| Affiliation |
AIIMS jodhpur |
| Address |
Department of Neurosurgery, AIIMS Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9511699859 |
| Fax |
|
| Email |
advaitpakhmode17007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Neurosurgery, AIIMS Jodhpur, Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Basni, Jodhpur, Rajasthan, India, 342005 |
|
|
Primary Sponsor
|
| Name |
Dr. Jaskaran Gosal |
| Address |
Department of Neurosurgery AIIMS Jodhpur |
| Type of Sponsor |
Other [Guide] |
|
|
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 Jaskaran Gosal |
AIIMS jodhpur |
Department of Neurosurgery, AIIMS Jodhpur, Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Basni, Jodhpur, Rajasthan 342005, India
Jodhpur
RAJASTHAN |
6283475891
jhsgosal_87@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Clinical Trial) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I60||Nontraumatic subarachnoid hemorrhage, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
Nimodipine 60mg Q6H will be administered to the control gorup |
| Intervention |
Treatment group |
Aspirin 75mg OD HS for 14 days with Nimodipine 60mg Q6H will be administered to patients in the intervention group |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria:
1. Patients visiting the AIIMS Jodhpur emergency or OPD or admitted under the Department of Neurosurgery in the study duration
2. Age above 18 years, and
3. Patients with SAH caused by ruptured intracranial aneurysm
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
1. Patients with non aneurysmal SAH
2. Patients with known allergy to aspirin
3. Pregnancy
4. Patients with known bleeding diathesis
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Aspirin decreases the incidence of postoperative cerebral vasospasm and delayed cerebral ischaemia in patients with aneurysmal subarachnoid haemorrhage |
Outcomes will be assessed and compared at 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improved quality of life and decreased morbidity of patients |
aspirin by preventing cerebral vasospasm and delayed cerebral ischaemia will decrease the morbidity and improve the quality of life after the surgery |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
21/03/2025 |
| 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="6"
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
|
This study is a randomized, controlled, single centre trial, comparing the effects of Aspirin 75mg once daily in 92 patients with aneurysmal subarachnoid hemorrhage who have undergone clipping of aneurysm on postoperative cerebral vasospasm and delayed cerebral ischemia. The duration of the study is for 18 months. The primary outcome is comparison between the incidence of cerebral vasospasm and delayed cerebral ischemia in the treatment group (Aspirin + Nimodipine) versus control group (Nimodipine) at 3 months. The secondary outcome is to compare the inflammatory markers (TLC, ESR, CRP) in both groups and functional outcome by mRS of patients in both groups at 3 months.
|