| 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
|
|
|
Primary Sponsor
|
| Name |
Command Hospital |
| Address |
Command Hospital, Pune |
| Type of Sponsor |
Research institution and hospital |
|
|
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 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
|
|
|
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 |
|
|
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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