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NCT Number: NCT07046858

Predictive Accuracy of PLR and PNR in Detecting ETIC

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

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jubilee Mission Medical College

Thrissur, Kerala, 670303, India

Location status: Recruiting

Location contact

Dr Amrutha T, MBBS

PRINCIPAL_INVESTIGATOR

Dr Siju V Abraham, MBBS MD

CONTACT

[email protected]

+91 94477 54321

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    PLR and PNR ratio in predicting in-hospital 30 day mortality

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

    Time frame: 24 hours

    Prolonged ventilators support

  3. 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

    Renal replacement therapy in patients with ETIC

  4. 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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Amrutha T, MBBS

CONTACT

[email protected]

+918547196022

Dr Siju V Abraham, MBBS MD

CONTACT

[email protected]

+919447754321

Sponsors and collaborators

Lead sponsor

Jubilee Mission Medical College and Research Institute

Other

Registry information

Official study title

Predictive Accuracy of Platelet Lymphocyte Ratio & Platelet Neutrophil Ratio in Detecting Early Trauma Induced Coagulopathy

Acronym: ETIC

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 2, 2025
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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