Predictive Accuracy of PLR and PNR in Detecting ETIC (ETIC)

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

Study Overview

• Status: Recruiting
• Conditions: Trauma Injury; Coagulopathy

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 Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Dr Siju V Abraham, MBBS MD; Phone Number: +919447754321; Email: sijuvabraham@gmail.com
• Study Contact Backup: Name: Dr Amrutha T, MBBS; Phone Number: +918547196022; Email: amruthathotten@gmail.com

Study Locations

• India
  • Kerala
    • Thrissur, Kerala, India, 670303
      • Recruiting
      • Jubilee Mission Medical College
      • Contact: Dr Siju V Abraham, MBBS MD; Phone Number: +91 94477 54321; Email: sijuvabraham@gmail.com
      • Principal Investigator: Dr Amrutha T, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

All patients with trauma AND Presenting to ED within 6 hrs of the event AND The ED Physician sends coagulation profile

Description

Inclusion Criteria:

• All patients with trauma AND
• Presenting to ED within 6 hours of the event AND
• The ED Physician sends coagulation profile

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Trauma patients with and without ETIC; All the trauma patients coming to ED for whom the physician send investigations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Sensitivity, specificity, positive and negative predictive value	PLR and PNR ratio in predicting in-hospital transfusion requirement during index hospital admission.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 hours
Compare the AUROC of PLR and PNR ratio in predicting prolonged ventilatory support (>21 days)	Prolonged ventilators support	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	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	24hours

Collaborators and Investigators

• Sponsor: Jubilee Mission Medical College and Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2023
• Primary Completion (Estimated): October 27, 2025
• Study Completion (Estimated): November 27, 2025

Study Registration Dates

• First Submitted: August 9, 2023
• First Submitted That Met QC Criteria: June 23, 2025
• First Posted (Actual): July 2, 2025

Study Record Updates

• Last Update Posted (Actual): July 2, 2025
• Last Update Submitted That Met QC Criteria: June 23, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Early trauma induced coagulopathy
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Wounds and Injuries; Hemostatic Disorders; Blood Coagulation Disorders
• Other Study ID Numbers: 47/23/IEC/JMMC&RI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No