Predictive Accuracy of PLR and PNR in Detecting ETIC

NCT07046858 | Recruiting

• 1 other identifier: 47/23/IEC/JMMC&RI
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Trauma Injury; Coagulopathy

Keywords

Early trauma induced coagulopathy

Outcome Measures

Primary Outcomes (1)

• 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 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

  24 hours

• Compare the AUROC of PLR and PNR ratio in predicting prolonged ventilatory support (>21 days)

  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)

  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)

  24hours

Study Arms (1)

Trauma patients with and without ETIC

All the trauma patients coming to ED for whom the physician send investigations

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jubilee Mission Medical College and Research Institute: lead

Study Sites (1)

Jubilee Mission Medical College

Thrissur, Kerala, 670303, India

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Accidental Injuries; Hemostatic Disorders

Condition Hierarchy (Ancestors)

Wounds and Injuries; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Dr Siju V Abraham, MBBS MD

CONTACT

+919447754321; sijuvabraham@gmail.com

Dr Amrutha T, MBBS

CONTACT

+918547196022; amruthathotten@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior Resident

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: July 2, 2025
• Study Start: October 17, 2023
• Primary Completion: October 27, 2025
• Study Completion: November 27, 2025
• Last Updated: July 2, 2025

Record last verified: 2025-06

Locations

IN (1)