| CTRI Number |
CTRI/2025/05/086429 [Registered on: 06/05/2025] Trial Registered Prospectively |
| Last Modified On: |
05/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing chest trauma severity scoring with mitochondrial dna level |
|
Scientific Title of Study
|
Comparing chest trauma severity scoring with levels of circulating mitochondrial dna as prognostic marker in chest trauma patients |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kavita Meena |
| Designation |
Associate Professor |
| Affiliation |
Institute of medical sciences Banaras Hindu university |
| Address |
Department of Anaesthesiology Institute of medical sciences BHU 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9711897587 |
| Fax |
|
| Email |
kavitameenabhu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ganesh S |
| Designation |
2nd year Post graduate Resident |
| Affiliation |
Institute of medical sciences Banaras Hindu university varansi 221005 |
| Address |
Department of Anaesthesiology Institute of medical sciences Banaras Hindu university 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9711897587 |
| Fax |
|
| Email |
ganig5219@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kavita Meena |
| Designation |
Associate professor Department of Anaesthesiology |
| Affiliation |
Institute of medical sciences Banaras Hindu university Varanasi 221005 |
| Address |
Department of Anaesthesiology Institute of medical sciences Banaras Hindu university 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9711897587 |
| Fax |
|
| Email |
kavitameenabhu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology Institute of medical sciences Banaras Hindu university varansi 221005 |
|
|
Primary Sponsor
|
| Name |
Department of anaesthesiology |
| Address |
Department of anaesthesiology Institute of medical sciences Banaras hindu university 221005 |
| 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 |
| Kavita Meena |
Institute of medical sciences Banaras hindu university |
Department of anaesthesiology Institute of medical sciences Banaras hindu university Varanasi 221005
Varanasi
UTTAR PRADESH |
09711897587
kavitameenabhu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee institute of medical sciences Banaras Hindu university varanasi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S299||Unspecified injury of thorax, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Blood sample collection for estimation of levels of mitochondrial dna |
Blood sample will be collected to check for levels of circulating mitochondrial dna in blood and it is compared with chest trauma severity scoring as prognostic marker |
| Intervention |
Observational study (chest trauma severity scoring assessment and blood sample collection for mitochondrial dna estimation) |
Chest trauma severity assessment and blood collection for mitochondrial dna estimation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient admitted to the emergency department within 24 hours
2. Patients with clinical symptoms and pulmonary infiltrative shadows
3. Patients requiring mechanical ventilation support
4. Patients with chest trauma with trauma as a causative factor; confirmation of blunt trauma based on clinical evaluation and diagnostic imaging (e.g., chest x-ray, ct scan)
5. Availability of blood samples for mitochondrial dna (mtdna) analysis at the time of admission or shortly thereafter
6. Written informed consent obtained from patients or legally authorized representatives for participation in the study |
|
| ExclusionCriteria |
| Details |
1) Patients with penetrating chest trauma (e.g., gunshot wounds, stab wounds) as
the primary mechanism of injury.
2) Patients with pre-existing medical conditions or comorbidities known to affect
mtDNA levels or alter prognostic outcomes (e.g., chronic inflammatory disorders,
mitochondrial diseases).
Patients with severe traumatic brain injury or other injuries requiring immediate
surgical intervention, potentially confounding the assessment of blunt chest
trauma outcomes.
3) Patients with history of Chronic lung disease, Autoimmune diseases, infections
4) Patients with history of Lung Surgery
5) Patients with ARDS with Non-Traumatic causes
6) Patients with active Bleeding conditions
Patients with incomplete medical records or missing data necessary for the
evaluation of clinical outcomes and severity scoring.
7) Pregnant patients, as pregnancy-related changes in mtDNA levels could
introduce confounding variables in the analysis.
8) Patients who decline or are unable to provide informed consent for participationPatients transferred from other healthcare facilities with incomplete
documentation of injury mechanism or clinical management prior to arrival.
in the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Compare Chest Trauma Severity Scoring with Levels of Circulating DNA as a
prognostic Marker |
1. Day of Admission( Day 1)
2. 3 rd Day
3. 7 th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) 28 days Mortality
2) Ventilatory Free days
3)Requirement of Mechanical ventilator support
4) Evaluate the association between circulating mtDNA levels and clinical outcomes
in chest trauma patients.
5) Compare the prognostic efficacy of mtDNA levels with traditional clinical findings
such as vital signs, physical examination, and imaging studies.
6) Investigate the feasibility of incorporating mtDNA analysis into routine prognostic assessments for chest trauma patients. |
1. Day of Admission( Day 1)
2. 3 rd Day
3. 7 th day |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
20/05/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 aims to evaluate whether levels of mitochondrial DNA in the blood can serve as a reliable prognostic marker in patients with chest trauma. The researchers compare standard chest trauma severity scores with circulating mtDNA levels, to see how well each predicts clinical outcomes such as complications, ICU stay, or mortality. Patients presenting with chest trauma are assessed using established severity scoring systems e.g., AIS, ISS. At the same time, blood samples are collected to measure mtDNA levels. The relationship between trauma severity, mtDNA concentration, and patient outcomes is analyzed to determine if mtDNA can enhance or replace existing scoring tools for prognosis. |