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CTRI Number  CTRI/2024/04/065394 [Registered on: 08/04/2024] Trial Registered Prospectively
Last Modified On: 27/02/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Prospective case series 
Study Design  Other 
Public Title of Study   Cadaveric organ donation 
Scientific Title of Study   Conversion of first apnea or ancilliary test positive potential brain-dead organ donors to donors: A prospective case series from a military organ transplant centre in India 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nitin Pahuja 
Designation  Assistant Professor 
Affiliation  Command Hospital/Armed Forced Medical College, Pune 
Address  Department of Anaesthesia and Critical Care, Command Hospital, Pune

Pune
MAHARASHTRA
411040
India 
Phone  9876087985  
Fax    
Email  pb_nitin@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Nitin Pahuja 
Designation  Assistant Professor 
Affiliation  Command Hospital/Armed Forced Medical College, Pune 
Address  Department of Anaesthesia and Critical Care, Command Hospital, Pune

Pune
MAHARASHTRA
411040
India 
Phone  9876087985  
Fax    
Email  pb_nitin@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Nitin Pahuja 
Designation  Assistant Professor 
Affiliation  Command Hospital/Armed Forced Medical College, Pune 
Address  Department of Anaesthesia and Critical Care, Command Hospital, Pune

Pune
MAHARASHTRA
411040
India 
Phone  9876087985  
Fax    
Email  pb_nitin@yahoo.co.in  
 
Source of Monetary or Material Support  
Command Hospital, Pune 
 
Primary Sponsor  
Name  Command Hospital 
Address  Command Hospital, Pune 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
None  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 Nitin Pahuja  Command Hospital, Pune  ICU, Department of Anaesthesia and Critical Care, Floor-5, Command Hospital
Pune
MAHARASHTRA 
9876087985

pb_nitin@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Armed Forces Medical College, Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G938||Other specified disorders of brain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Patients meeting the clinical criteria for brain death

Positive first apnea or ancilliary test 
 
ExclusionCriteria 
Details  None 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the challenges which prevent successful conversion of potential brain-dead organ donors to donors  6 months or time to enroll minimum of 8 patients whichever is later 
 
Secondary Outcome  
Outcome  TimePoints 
None  Not applicable 
 
Target Sample Size   Total Sample Size="8"
Sample Size from India="8" 
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" 
Phase of Trial   N/A 
Date of First Enrollment (India)   21/04/2024 
Date of Study Completion (India) 20/06/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
     As per data released in May 2022 by Indian Society of Organ Transplants, patients waiting for various organs transplant in India are approximately 3.17 lakhs. Approximately 55% of these patients are waiting for kidney transplant. However only less than 10% patients requiring kidney transplant end up receiving a kidney. A large majority of organ donations in India are from live donors. Cadaver donations represent only about  5% of all donations. As per data for the year 2021 from National Crime Records Bureau, the fatalities attributed to road traffic accident in India were approximately 1.55 lakhs. The cause was head injury in 40-50% of cases. About 70% of the accidents involved young adults.
      It is estimated that if 5-10% of all brain-dead patients are considered for organ harvesting, there would be no requirement for a living person to donate organs. However the donation of organs from brain-dead patients is highly under-utilized due to lack of awareness, religious beliefs and challenges in identifying potential brain-dead organ donors and managing them prior to organs retrieval.
     To boost the number of potential donors and increase cadaver (post brain death) organ donations, the government of Maharashtra has passed a resolution making it mandatory for authorized medical practioners to certify the patients who have reached the brain dead stage as brain-dead without wasting time. The government resolution underlines the responsibilities of hospitals registered under Transplantation of Human Organs (THO) Act 1994 that are authorized transplant centers. As per Indian law, two apnea tests are required to be done at minimum of 6 hours apart in a patient having no brainstem reflexes to declare him/her as brain-dead. If apnea test is inconclusive or could not be done, various ancillary tests may be performed like electroencephalography, trans-cranial doppler, coronary angiography, etc. However due to various factors, some of these potential donors do not end up becoming actual donors due to factors mentioned above.
     The present prospective case series aims at assessing the challenges that prevent successful conversion of potential brain-dead organ donors to actual organ donors. This study will be conducted at a military organ transplant center in India.
 
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