Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-01-02 @ 4:04 AM
Study NCT ID:
NCT07046858
Status:
RECRUITING
Last Update Posted:
2025-07-02
First Post:
2023-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Accuracy of PLR and PNR in Detecting ETIC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081084', 'term': 'Accidental Injuries'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-11-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-23', 'studyFirstSubmitDate': '2023-08-09', 'studyFirstSubmitQcDate': '2025-06-23', 'lastUpdatePostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1. Sensitivity, specificity, positive and negative predictive value', 'timeFrame': '24 hours', 'description': 'PLR and PNR ratio in predicting in-hospital transfusion requirement during index hospital admission.'}], 'secondaryOutcomes': [{'measure': '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', 'timeFrame': '24 hours', 'description': 'PLR and PNR ratio in predicting in-hospital 30 day mortality'}, {'measure': 'Compare the AUROC of PLR and PNR ratio in predicting prolonged ventilatory support (>21 days)', 'timeFrame': '24 hours', 'description': 'Prolonged ventilators support'}, {'measure': '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)', 'timeFrame': '24hours', 'description': 'Renal replacement therapy in patients with ETIC'}, {'measure': '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)', 'timeFrame': '24hours', 'description': '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'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Early trauma induced coagulopathy'], 'conditions': ['Trauma Injury', 'Coagulopathy']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.\n\nLymphocytes 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.\n\nThe 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with trauma AND Presenting to ED within 6 hrs of the event AND The ED Physician sends coagulation profile', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with trauma AND\n* Presenting to ED within 6 hours of the event AND\n* The ED Physician sends coagulation profile\n\nExclusion Criteria:\n\n* Treated with intravenous fluids, drugs, whole blood and blood products elsewhere\n* 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\n* Patients on known medications affecting coagulation profile or hemogram\n* Patients with known chronic liver disease, chronic renal failure, malignancy, hematological disorders\n* Patients not consenting for the study'}, 'identificationModule': {'nctId': 'NCT07046858', 'acronym': 'ETIC', 'briefTitle': 'Predictive Accuracy of PLR and PNR in Detecting ETIC', 'organization': {'class': 'OTHER', 'fullName': 'Jubilee Mission Medical College and Research Institute'}, 'officialTitle': 'Predictive Accuracy of Platelet Lymphocyte Ratio & Platelet Neutrophil Ratio in Detecting Early Trauma Induced Coagulopathy', 'orgStudyIdInfo': {'id': '47/23/IEC/JMMC&RI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Trauma patients with and without ETIC', 'description': 'All the trauma patients coming to ED for whom the physician send investigations'}]}, 'contactsLocationsModule': {'locations': [{'zip': '670303', 'city': 'Thrissur', 'state': 'Kerala', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Dr Siju V Abraham, MBBS MD', 'role': 'CONTACT', 'email': 'sijuvabraham@gmail.com', 'phone': '+91 94477 54321'}, {'name': 'Dr Amrutha T, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Jubilee Mission Medical College', 'geoPoint': {'lat': 10.51667, 'lon': 76.21667}}], 'centralContacts': [{'name': 'Dr Siju V Abraham, MBBS MD', 'role': 'CONTACT', 'email': 'sijuvabraham@gmail.com', 'phone': '+919447754321'}, {'name': 'Dr Amrutha T, MBBS', 'role': 'CONTACT', 'email': 'amruthathotten@gmail.com', 'phone': '+918547196022'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jubilee Mission Medical College and Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Junior Resident', 'investigatorFullName': 'Amrutha Thotten', 'investigatorAffiliation': 'Jubilee Mission Medical College and Research Institute'}}}}