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CTRI Number  CTRI/2024/03/064429 [Registered on: 19/03/2024] Trial Registered Prospectively
Last Modified On: 24/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Surgical options offered for spontaneous brain hemorrhage.  
Scientific Title of Study   Spontaneous intracerebral hemorrhage - outcomes of different surgical approaches  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Geeta S 
Designation  Senior Resident  
Affiliation  Department of Neurosurgery, KMC, Manipal, MAHE University 
Address  Department of Neurosurgery, Kasturba Hospital, KMC, Manipal, MAHE University, Manipal 576104, Udupi District, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9632462974  
Fax    
Email  harry_geeta@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr. Raghavendra Nayak 
Designation  Professor and Head of Department 
Affiliation  Department of Neurosurgery, KMC, Manipal, MAHE University 
Address  Department of Neurosurgery, Kasturba Hospital, KMC, Manipal, MAHE University, Manipal 576104, Udupi District, Karnataka

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  nayakraghu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Geeta S 
Designation  Senior Resident  
Affiliation  Department of Neurosurgery, KMC, Manipal, MAHE University 
Address  Department of Neurosurgery, Kasturba Hospital, KMC, Manipal, MAHE University, Manipal 576104, Udupi District, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9632462974  
Fax    
Email  harry_geeta@yahoo.co.in  
 
Source of Monetary or Material Support  
Kasturba Hospital, Kasturba Medical College, Manipal, Manipal 576104, Udupi District, Karnataka, India 
 
Primary Sponsor  
Name  Kasturba Hospital, Manipal  
Address  Kasturba Hospital, Manipal, Manipal 576104, Udupi District, Karnataka 
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 Geeta S  Kasturba Hospital, Manipal   Department of Neurosurgery, Room No 12, OPD Block, Kasturba Hospital, Manipal, Manipal 576104, Udupi District, Karnataka
Udupi
KARNATAKA 		 9632462974

harry_geeta@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G939||Disorder of brain, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients between 18 to 70 years. Informed consent for surgery is given by patient or their family. New onset SIH (72 hours of ictus). GCS 5 or more. Hematoma volume greater than 30 ml. 
 
ExclusionCriteria 
Details  Patients or family not giving consent for surgery. Traumatic ICH . Pregnant patients . Age less than 18 years or greater than 70 years. Patients not on regular follow up. GCS on arrival E1M1V1 with absent brainstem reflexes. If prior or present history of an intracranial tumor, aneurysm or vascular pathology, or stroke and or status post chemotherapy or radiotherapy. Hematoma involving the posterior fossa or brainstem or midbrain. Those patients with SIH that didn’t warrant surgery as per the senior consultants decision. Those patients undergoing medical management. If CT scan at the time of presentation shows completely effaced basal cisterns, advanced herniation and midline shift greater than 1cm. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary outcomes are mRS modified Rankin Scale at 3 months follow up and Effective hematoma evacuation or residual hematoma volume   mRS will be evaluated at 3 months post discharge.  
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcomes are Complications rebleed, meningitis, postoperative new deficits. ICU stay in days. Hospital stay in days. Tracheostomy, if done. If on oral feeds at time of discharge. Late neurological deterioration & Perioperative mortality  mRS will be evaluated at 3 months post discharge.  
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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)   15/04/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response (Others) -  Images from the intra-operative findings
  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [harry_geeta@yahoo.co.in].

  6. For how long will this data be available start date provided 01-12-2025 and end date provided 01-12-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary
Modification(s)  

Through this study, we aim to understand the differences and impact of microsurgical, endoscopic evacuation and decompressive craniectomy for spontaneous intracranial hemorrhage (SIH) as carried out in our local setting. This study hopes to identify the better surgical technique for SIH and also the effectiveness of the minimally invasive surgeries like endoscopic and microsurgical techniques in management of SIH.

 
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