- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07832903
Serial Platelet Count and Indices for Predicting In-Hospital Mortality in Sepsis
Predictive Value of Serial Platelet Count, and Platelet Indices for In-Hospital Mortality in Patients With Sepsis: A Cohort Study
This observational study aims to determine if tracking changes in blood platelets over time can help predict the clinical outcomes of adult patients hospitalized with sepsis. While current medical scoring systems (like SOFA and APACHE) help doctors evaluate a patient's risk when they are first admitted, they are often static and may not capture how the body's response changes during the infection. Platelet count and the size of the platelets (mean platelet volume) change dynamically during sepsis.
Researchers will observe the routine daily blood test results of adult sepsis patients during their first 7 to 14 days in the hospital to track these changes. By calculating specific platelet ratios and analyzing their trajectories, the study hopes to find out if these simple, cost-effective markers can accurately predict a patient's risk of in-hospital mortality, and if they can improve the accuracy of current standard severity scores.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
During sepsis, platelet count (PC) and mean platelet volume (MPV) act as dynamic markers reflecting systemic inflammation, platelet consumption, marrow response, and platelet activation. Current prognostic tools, such as the SOFA and APACHE II/IV scores, provide important baseline risk stratification but are relatively static and may not fully capture the evolving host response to infection.
Emerging evidence indicates that serial platelet indices yield greater prognostic information than single, baseline measurements. Furthermore, composite platelet-derived metrics-such as the MPV/PC ratio, platelet-to-lymphocyte ratio (PLR), CRP-to-platelet ratio (CRP/PLT), and platelet-to-creatinine ratio (PLT/Cr)-integrate signals of inflammation, haemostasis, and organ dysfunction, which may enhance clinical risk prediction. Despite these signals, few prospective studies have simultaneously examined the serial trajectories of PC and MPV, their derived ratios, and their incremental value beyond conventional severity scores.
This prospective cohort study hypothesizes that serial PC and MPV dynamics, along with derived platelet ratios, independently predict in-hospital mortality in adults with sepsis after adjusting for clinical confounders. Demonstrating independent prognostic value and improved reclassification when these trajectory-based markers are combined with SOFA or APACHE scores would support incorporating routine, time-updated platelet indices into sepsis prognostication and risk-stratified management.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Ahmed Abdelwahed
- Telefonní číslo: 01115279800
- E-mail: ahmed.18313435@med.aun.edu.eg
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Adult patients admitted to the hospital or Intensive Care Unit (ICU) at Assiut University Hospitals who are diagnosed with sepsis.
Popis
Inclusion Criteria:
- Adults (>18 years).
- Admitted to the hospital/ICU with sepsis as defined by Sepsis-3 criteria (suspected/proven infection plus an acute increase in SOFA score >= 2).
Exclusion Criteria:
- Age <18 years.
- Known hematologic malignancy with active chemotherapy affecting platelets.
- Platelet transfusion within 24 hours before the first platelet measurement.
- Chronic thrombocytopenia from non-sepsis causes (e.g., immune thrombocytopenia).
- Missing core baseline data (e.g., date of admission, vital status).
- Declined consent.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: PROSPECTIVE
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
Adult Sepsis Cohort
Adult patients (older than 18 years) admitted to the hospital or Intensive Care Unit (ICU) who are diagnosed with sepsis according to Sepsis-3 criteria (suspected or proven infection plus an acute increase in SOFA score of 2 or more) |
Routine automated complete blood counts, including platelet count (PC) and mean platelet volume (MPV), collected serially during the first 7-14 days of admission. These are used to evaluate biological trajectories and calculate derived indices (MPV/PC, PLR, CRP/PLT, and PLT/Cr) |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
In-hospital mortality
Časové okno: From hospital admission until hospital discharge, assessed up to 28 days.
|
Death of the patient from any cause prior to hospital discharge, evaluated as a binary outcome (survivor vs. non-survivor). |
From hospital admission until hospital discharge, assessed up to 28 days.
|
Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- Aydemir H, Piskin N, Akduman D, Kokturk F, Aktas E. Platelet and mean platelet volume kinetics in adult patients with sepsis. Platelets. 2015;26(4):331-5. doi: 10.3109/09537104.2012.701027. Epub 2012 Jun 25.
- Schupp T, Weidner K, Rusnak J, Jawhar S, Forner J, Dulatahu F, Bruck LM, Hoffmann U, Kittel M, Bertsch T, Akin I, Behnes M. Diagnostic and prognostic role of platelets in patients with sepsis and septic shock. Platelets. 2023 Dec;34(1):2131753. doi: 10.1080/09537104.2022.2131753.
- Wang D, Wang S, Wu H, Gao J, Huang K, Xu D, Ru H. Association Between Platelet Levels and 28-Day Mortality in Patients With Sepsis: A Retrospective Analysis of a Large Clinical Database MIMIC-IV. Front Med (Lausanne). 2022 Apr 7;9:833996. doi: 10.3389/fmed.2022.833996. eCollection 2022.
- Thorup CV, Christensen S, Hvas AM. Immature Platelets As a Predictor of Disease Severity and Mortality in Sepsis and Septic Shock: A Systematic Review. Semin Thromb Hemost. 2020 Apr;46(3):320-327. doi: 10.1055/s-0039-3400256. Epub 2019 Dec 13.
- Tekin YK, Tekin G. Mean Platelet Volume-to-Platelet Count Ratio, Mean Platelet Volume-to-Lymphocyte Ratio, and Red Blood Cell Distribution Width-Platelet Count Ratio as Markers of Inflammation in Patients with Ascending Thoracic Aortic Aneurysm. Braz J Cardiovasc Surg. 2020 Apr 1;35(2):175-180. doi: 10.21470/1678-9741-2019-0348.
- Zhao L, Zhao L, Wang YY, Yang F, Chen Z, Yu Q, Shi H, Huang S, Zhao X, Xiu L, Li X, Li Y. Platelets as a prognostic marker for sepsis: A cohort study from the MIMIC-III database. Medicine (Baltimore). 2020 Nov 6;99(45):e23151. doi: 10.1097/MD.0000000000023151.
- Liu Y, Zou Y, Liu X, Li M. Stratified assessment of platelets in sepsis: from dynamic counts to functional phenotypes. Front Immunol. 2026 Apr 10;17:1783001. doi: 10.3389/fimmu.2026.1783001. eCollection 2026.
- Ye Q, Wang X, Xu X, Chen J, Christiani DC, Chen F, Zhang R, Wei Y. Serial platelet count as a dynamic prediction marker of hospital mortality among septic patients. Burns Trauma. 2024 Jun 15;12:tkae016. doi: 10.1093/burnst/tkae016. eCollection 2024.
- Lobo SM, Lobo FR, Bota DP, Lopes-Ferreira F, Soliman HM, Melot C, Vincent JL. C-reactive protein levels correlate with mortality and organ failure in critically ill patients. Chest. 2003 Jun;123(6):2043-9. doi: 10.1378/chest.123.6.2043.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Serial platelets in sepsis
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