SepsisNCT07832903
Serial Platelet Count and Indices for Predicting In-Hospital Mortality in Sepsis
An observational study of Sepsis, run by Assiut University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Serial Complete Blood Counts (CBC)
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients admitted to the hospital or Intensive Care Unit (ICU) at Assiut University Hospitals who are diagnosed with sepsis.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Sepsis
- Being tested
- Serial Complete Blood Counts (CBC)
- Keywords
- Platelet count, Mean platelet volume, Platelet indices, Systemic inflammation, In-hospital mortality
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serial Complete Blood Counts (CBC)Diagnostic test
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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Diagnostic Test: Serial Complete Blood Counts (CBC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
Death of the patient from any cause prior to hospital discharge, evaluated as a binary outcome (survivor vs. non-survivor).
Measured: From hospital admission until hospital discharge, assessed up to 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelwahed Abdeljaber Abdelmawjood, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07832903
- Sponsor's protocol ID
- Serial platelets in sepsis
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 22731700Schupp 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.
PubMed 36484263Wang 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.
PubMed 35463034Thorup 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.
PubMed 31858518Tekin 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.
PubMed 32369297Zhao 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.
PubMed 33157998Liu 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.
PubMed 42039178Ye 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.
PubMed 38882552Lobo 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.
PubMed 12796187
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Serial Platelet Count, and Platelet Indices for In-Hospital Mortality in Patients With Sepsis: A Cohort Study
- ClinicalTrials.gov ID
- NCT07832903
- Acronym / sponsor ID
- Serial platelets in sepsis
- Conditions
- Sepsis
- Keywords
- Platelet count, Mean platelet volume, Platelet indices, Systemic inflammation, In-hospital mortality
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult Sepsis Cohort | – | Diagnostic Test: Serial Complete Blood Counts (CBC)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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to the hospital or Intensive Care Unit (ICU) at Assiut University Hospitals who are diagnosed with sepsis.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serial Complete Blood Counts (CBC)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) | Diagnostic test | Adult Sepsis Cohort |
Primary outcome
In-hospital mortality
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Background: PubMed 22731700Aydemir 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.
- Background: PubMed 36484263Schupp 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.
- Background: PubMed 35463034Wang 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.
- Background: PubMed 31858518Thorup 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.
- Background: PubMed 32369297Tekin 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.
- Background: PubMed 33157998Zhao 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.
- Background: PubMed 42039178Liu 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.
- Background: PubMed 38882552Ye 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.
- Background: PubMed 12796187Lobo 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Abdelwahed (01115279800, ahmed.18313435@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital mortality (time frame: From hospital admission until hospital discharge, assessed up to 28 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07832903, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.