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RecruitingNCT07046858ETICUpdated Jul 2, 2025

Predictive Accuracy of PLR and PNR in Detecting ETIC

An observational study in Trauma Injury and Coagulopathy, sponsored by Jubilee Mission Medical College and Research Institute. Recruiting at 1 site in India. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-02.

Sponsored by Jubilee Mission Medical College and Research Institute · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year ago, but the record still lists the study as recruiting.
  • Started Oct 2023; still recruiting 3 years later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
250
Ages
12 Years and older
Sex
All
01

Study 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 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

02

Conditions studied

  • Trauma Injury
  • Coagulopathy

Keywords

  • Early trauma induced coagulopathy
03

In context

Accidental Injuries

128 studies on the registry are indexed under Accidental Injuries; 39 are open to participants now.

This study's planned enrollment of 250 is above the median of 170 across 59 observational studies indexed under Accidental Injuries.

Browse Accidental Injuries studies →

Lead sponsor

Jubilee Mission Medical College and Research Institute is the lead sponsor of 25 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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, , hematological disorders
  • Patients not consenting for the study
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
250 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Trauma patients with and without ETIC

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

06

What researchers measure

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.

    Time frame: 24 hours

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

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

    Time frame: 24 hours

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

    Prolonged ventilators support

    Time frame: 24 hours

  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)

    Renal replacement therapy in patients with ETIC

    Time frame: 24hours

  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)

    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

    Time frame: 24hours

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2023 (actual). Primary completion is estimated for Oct 2025, 24 months after the start.

Of 33 non-industry observational studies under Accidental Injuries, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 60. This study's planned 24 months is close to that.

Counting every sponsor, half of 39 studies reached it within 31 months; a quarter within 12 and three quarters within 60.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 9, 2023
First posted
Jul 2, 2025
StartActual
Oct 17, 2023
Primary completionEst.
Oct 27, 2025
CompletionEst.
Nov 27, 2025
Last update
Jul 2, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07046858
Lead sponsor
Jubilee Mission Medical College and Research Institute
Responsible party
Amrutha Thotten (Junior Resident, Jubilee Mission Medical College and Research Institute) — Principal investigator
First posted
Jul 2, 2025
Start date
Oct 17, 2023
Primary completion
Oct 27, 2025 (estimated)
Completion
Nov 27, 2025 (estimated)
Last update
Jul 2, 2025

Study contacts

Dr Siju V Abraham, MBBS MD
Contact
sijuvabraham@gmail.com
+919447754321
Dr Amrutha T, MBBS
Contact
amruthathotten@gmail.com
+918547196022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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