| CTRI Number |
CTRI/2025/04/084073 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
02/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Serum Biomarkers in Children with Head Injury for Predicting Outcomes |
|
Scientific Title of Study
|
Evalution of Lactate to Albumin and C-reactive Protein to Albumin Ratios as Prognostic Biomarkers in Pediatric traumatic Brain injury: A Retrospective Observational Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashish Bindra |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New delhi, India. |
| Address |
Room No. 118, First-Floor, Faculty Block, JPN Apex Trauma Centre, All India Institute of Medical Sciences (AIIMS), New Delhi
All India Institute of Medical Sciences, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8826417127 |
| Fax |
|
| Email |
dr_ashi2208@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashish Bindra |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New delhi, India. |
| Address |
Room No. 118, First-Floor, Faculty Block, JPN Apex Trauma Centre, All India Institute of Medical Sciences (AIIMS), New Delhi
All India Institute of Medical Sciences, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8826417127 |
| Fax |
|
| Email |
dr_ashi2208@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashish Bindra |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New delhi, India. |
| Address |
Room No. 118, First-Floor, Faculty Block, JPN Apex Trauma Centre, All India Institute of Medical Sciences (AIIMS), New Delhi
All India Institute of Medical Sciences, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8826417127 |
| Fax |
|
| Email |
dr_ashi2208@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Jai Prakash Narayan Apex ,Trauma Centre,All India Institute of Medical Science, Ansari Nagar ,New Delhi,India, 110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Science,New Delhi |
| Address |
AIIMS,Anasri Nagar, New Delhi, 110029 |
| 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 |
| Dr Ashish Bindra |
All India Institute Of Medical Science, New Delhi |
Room No. 118, First-Floor, , Department Of Neuroanesthesiology & Critical Care ,Jai Prakash Narayan Apex Trauma Centre.
New Delhi
DELHI |
08826417127
dr_ashi2208@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE ALL INDIA INSTITUTE OF MEDICAL SCIENCE, NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S00-S09||Injuries to the head, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
Observational study |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Children with aged up t0 15 years with moderate to severe traumatic brain injury are admitted to neuro ICU within 24 hours of injury |
|
| ExclusionCriteria |
| Details |
Patient aged above 15 years ,admitted to Neuro ICU more 24 hours of post injury, with minor head injuries (14-15), non TBI cause of head drowsiness and pre existing chronic illness( e.g. autoimmune disorder and CDK) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Morality within 24 hours,30 days and 90 days. |
24 hours, 30 days and 90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Admission duration,total ICU stay, need for mechanical ventilation, and inotrope support. |
Till discharge |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
13/04/2025 |
| 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) |
Closed to Recruitment of Participants |
|
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
|
Pediatric
traumatic brain injury (TBI) is a leading cause of morbidity and mortality,
necessitating accurate prognostic tools for early risk stratification.
Traditional tools like the Glasgow Coma Scale (GCS) and Pediatric Index of
Mortality 2 (PIM2) often fail to capture the complex metabolic and inflammatory
responses associated with TBI. Emerging biomarkers, such as the
lactate-to-albumin ratio (LAR) and C-reactive protein-to-albumin ratio (CAR),
offer a more nuanced evaluation of systemic inflammation, hypoperfusion, and
nutritional status. This study evaluates the utility of LAR and CAR as
prognostic markers for mortality in pediatric TBI, comparing their predictive
accuracy with GCS and PIM2. The findings aim to establish these markers as
cost-effective, accessible tools to enhance clinical decision-making and improve
outcomes, especially in resource-limited settings.By analyzing 18 months of data (July 2023–January 2025) from an ongoing ICMR project at AIIMS, New Delhi, the study compares LAR and CAR with existing prognostic markers. Key outcomes include mortality at 24 hours, 30 days, and 90 days, along with ICU stay, mechanical ventilation, and inotrope support, aiming to establish these biomarkers as cost-effective tools for clinical decision-making. |