Trauma InjuryETICNCT07046858
Predictive Accuracy of PLR and PNR in Detecting ETIC
An observational study of Trauma Injury and Coagulopathy, run by Jubilee Mission Medical College and Research Institute at 1 site in India.
Trial summary
Observational study to know what is the predictive accuracy of platelet-neutrophil ratio (PNR) and platelet-lymphocyte ratio (PLR) done in patients presenting to ED( emergency department)within 6 hours of trauma; in detecting early trauma induced coagulopathy during hospital admission Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Trauma Injury, Coagulopathy
- How many people
- 250 participants
- Where
- 1 siteIndia
- Study dates
- 17 Oct 2023to 27 Nov 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All patients with trauma AND Presenting to ED within 6 hrs of the event AND The ED Physician sends coagulation profile
Who may be able to join
- All patients with trauma AND
- Presenting to ED within 6 hours of the event AND
- The ED Physician sends coagulation profile
Who cannot join
- Treated with intravenous fluids, drugs, whole blood and blood products elsewhere
- Patients admitted with a non-mechanical mechanism of injury, specifically drowning, hanging,or burns, as these mechanisms may result in a different biologic response than mechanical trauma
- Patients on known medications affecting coagulation profile or hemogram
- Patients with known chronic liver disease, chronic renal failure, malignancy, hematological disorders
- Patients not consenting for the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Jubilee Mission Medical College
Thrissur, Kerala, 670303
Dr Siju V Abraham, MBBS MD, +91 94477 54321, sijuvabraham@gmail.com
Dr Amrutha T, MBBS
About this study
Official title: Predictive Accuracy of Platelet Lymphocyte Ratio & Platelet Neutrophil Ratio in Detecting Early Trauma Induced Coagulopathy
Observational study to know what is the predictive accuracy of platelet-neutrophil ratio (PNR) and platelet-lymphocyte ratio (PLR) done in patients presenting to ED( emergency department)within 6 hours of trauma; in detecting early trauma induced coagulopathy during hospital admission
Read the detailed description
Trauma has a significant impact on the wellbeing and healthcare for the populations. Millions of patients seek medical help as a result of trauma, with a substantial proportion of patients suffering from life-changing or life-limiting injuries. The leading cause of traumatic death worldwide is road traffic collision, followed by suicide and homicide.(4) The role of platelets in the hemostasis and coagulation is crucial. Platelet interaction with lymphocytes, neutrophils, and monocytes modifies both the innate and adaptive immune responses.Platelets stick to the damaged endothelium and recruit leukocytes to the sites of injury.
Lymphocytes are the major cellular components of the humoral and cell-mediated immune system which include T, B, and natural killer cells. Platelet-lymphocyte ratio (PLR), platelet- neutrophil ratio (PNR) could reflect the balance between the body response to inflammation and immunity mediators Previously, few studies have tested the usefulness of PLR, PNR for predicting the outcomes in stroke , cardiovascular diseases. abdominal trauma, ARDS (Acute Respiratory Distress Syndrome) \& sepsis. I would like to do a study, where the results could be utilized in a resource limited hospital , for early referral and the prognostic value of these biomarkers in predicting ETIC in trauma.
The present study hypothesize that the on-admission PLR , PNR values would help early risk stratification and timely management of trauma patients which subsequently improve the outcomes
- Conditions
- Trauma Injury, Coagulopathy
- Keywords
- Early trauma induced coagulopathy
- Medical subject headings
- Accidental Injuries, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Trauma patients with and without ETIC | All the trauma patients coming to ED for whom the physician send investigations |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Sensitivity, specificity, positive and negative predictive value
PLR and PNR ratio in predicting in-hospital transfusion requirement during index hospital admission.
Measured: 24 hours
Secondary outcomes (4)
Compare the AUROC ( Area Under the Receiver Operating Characteristic Curve) of PLR and PNR ratio in predicting in-hospital transfusion requirement during index hospital admission
PLR and PNR ratio in predicting in-hospital 30 day mortality
Measured: 24 hours
Compare the AUROC of PLR and PNR ratio in predicting prolonged ventilatory support (>21 days)
Prolonged ventilators support
Measured: 24 hours
Compare the incidence of emergent surgery, renal replacement therapy amongst patients developing ETIC and those who do not during the duration of hospital stay or within 30 days (whichever is earlier)
Renal replacement therapy in patients with ETIC
Measured: 24hours
Compare the length of hospital stay, total number of surgeries, total intensive care days in numbers amongst patients developing ETIC and those who do not during the duration of hospital stay or within 30 days (whichever is earlier)
length of hospital stay, total number of surgeries, total intensive care days in numbers amongst patients developing ETIC and those who do not during the duration of hospital stay or within 30 days
Measured: 24hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start17 Oct 2023
- Primary completion27 Oct 2025 (estimated)
- Study completion27 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Jubilee Mission Medical College and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amrutha Thotten, Jubilee Mission Medical College and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046858
- Sponsor's protocol ID
- 47/23/IEC/JMMC&RI
- Acronym
- ETIC
- Status last verified
- Jun 2025
- First submitted
- 9 Aug 2023
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Accuracy of Platelet Lymphocyte Ratio & Platelet Neutrophil Ratio in Detecting Early Trauma Induced Coagulopathy
- ClinicalTrials.gov ID
- NCT07046858
- Acronym / sponsor ID
- ETIC / 47/23/IEC/JMMC&RI
- Conditions
- Trauma Injury, Coagulopathy
- Keywords
- Early trauma induced coagulopathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Jubilee Mission Medical College and Research InstituteUniversity, hospital or other
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- 27 Oct 2025 (estimated)
- Study completion
- 27 Nov 2025 (estimated)
- First posted
- 2 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observational study to know what is the predictive accuracy of platelet-neutrophil ratio (PNR) and platelet-lymphocyte ratio (PLR) done in patients presenting to ED( emergency department)within 6 hours of trauma; in detecting early trauma induced coagulopathy during hospital admission
Detailed description
Trauma has a significant impact on the wellbeing and healthcare for the populations. Millions of patients seek medical help as a result of trauma, with a substantial proportion of patients suffering from life-changing or life-limiting injuries. The leading cause of traumatic death worldwide is road traffic collision, followed by suicide and homicide.(4) The role of platelets in the hemostasis and coagulation is crucial. Platelet interaction with lymphocytes, neutrophils, and monocytes modifies both the innate and adaptive immune responses.Platelets stick to the damaged endothelium and recruit leukocytes to the sites of injury.
Lymphocytes are the major cellular components of the humoral and cell-mediated immune system which include T, B, and natural killer cells. Platelet-lymphocyte ratio (PLR), platelet- neutrophil ratio (PNR) could reflect the balance between the body response to inflammation and immunity mediators Previously, few studies have tested the usefulness of PLR, PNR for predicting the outcomes in stroke , cardiovascular diseases. abdominal trauma, ARDS (Acute Respiratory Distress Syndrome) \& sepsis. I would like to do a study, where the results could be utilized in a resource limited hospital , for early referral and the prognostic value of these biomarkers in predicting ETIC in trauma.
The present study hypothesize that the on-admission PLR , PNR values would help early risk stratification and timely management of trauma patients which subsequently improve the outcomes
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trauma patients with and without ETIC | – | –All the trauma patients coming to ED for whom the physician send investigations |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with trauma AND Presenting to ED within 6 hrs of the event AND The ED Physician sends coagulation profile
Key inclusion criteria (3 listed)
- All patients with trauma AND
- Presenting to ED within 6 hours of the event AND
- The ED Physician sends coagulation profile
Key exclusion criteria (5 listed)
- Treated with intravenous fluids, drugs, whole blood and blood products elsewhere
- Patients admitted with a non-mechanical mechanism of injury, specifically drowning, hanging,or burns, as these mechanisms may result in a different biologic response than mechanical trauma
- Patients on known medications affecting coagulation profile or hemogram
- Patients with known chronic liver disease, chronic renal failure, malignancy, hematological disorders
- Patients not consenting for the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
1. Sensitivity, specificity, positive and negative predictive value
Time frame: 24 hours
PLR and PNR ratio in predicting in-hospital transfusion requirement during index hospital admission.
4 secondary outcomes
Compare the AUROC ( Area Under the Receiver Operating Characteristic Curve) of PLR and PNR ratio in predicting in-hospital transfusion requirement during index hospital admission
Time frame: 24 hours
Compare the AUROC of PLR and PNR ratio in predicting prolonged ventilatory support (>21 days)
Time frame: 24 hours
Compare the incidence of emergent surgery, renal replacement therapy amongst patients developing ETIC and those who do not during the duration of hospital stay or within 30 days (whichever is earlier)
Time frame: 24hours
Compare the length of hospital stay, total number of surgeries, total intensive care days in numbers amongst patients developing ETIC and those who do not during the duration of hospital stay or within 30 days (whichever is earlier)
Time frame: 24hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma Injury and Coagulopathy, run by Jubilee Mission Medical College and Research Institute at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Siju V Abraham, MBBS MD (+919447754321, sijuvabraham@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Sensitivity, specificity, positive and negative predictive value (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.