SepsisNCT07230067
Sepsis-associated Thrombocytopenia and Platelet Transfusion (STAPT)
An observational study of Sepsis and Sepsis and Coagulopathy, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Currently, there are no multicenter studies on platelet transfusion for SAT patients, and the benefits and risks of platelet transfusion still require further validation based on large-sample data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Sepsis and Coagulopathy
- What is being tested?
- SAT patients
- Type of treatment
- Injection or infusion
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2025to 31 Mar 2027
- 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: Meeting the Sepsis-3.0 diagnostic criteria and platelet count < 100 × 10⁹/L at ICU admission
Who may be able to join
- Patients admitted to the ICU between January 2021 and May 2024 and subsequently discharged
- Age ≥ 18 years
- Meeting the Sepsis-3.0 diagnostic criteria
- Platelet count < 100 × 10⁹/L at ICU admission
- ICU length of stay ≥ 48 hours
Who cannot join
- Active bleeding (e.g., major gastrointestinal bleeding, intracranial hemorrhage) or hematologic malignancies (e.g., leukemia, myelodysplastic syndrome, lymphoma);
- Liver cirrhosis (Child-Pugh class B/C), chronic kidney disease (CKD stage 4-5), or autoimmune diseases (e.g., systemic lupus erythematosus);
- Receipt of chemotherapy, immunosuppressants (e.g., cyclosporine, rituximab), or hematopoietic stem cell/solid organ transplantation within 2 weeks;
- Pregnancy or lactation;
- Pre-existing chronic thrombocytopenia (baseline platelet count <100×10⁹/L for >1 month) or long-term use of antiplatelet/anticoagulant drugs (>2 weeks);
- Significant baseline coagulation dysfunction at ICU admission:Prothrombin time (PT) >1.5 times the upper limit of normal; Activated partial thromboplastin time (APTT) >1.5 times the upper limit of normal; Fibrinogen level <1.0 g/L;
- APACHE II score ≥30 within 24 hours of ICU admission;
- Missing >20% of key data (e.g., daily platelet counts, ICU survival status within 28 days).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Lulan Li, Ph.D, 86-13631309571, lilulanlilulan@163.com
Zhenhua Zeng, Ph.D, 86-15692428912, zhenhuazeng.2008@163.com
About this study
Official title: The Impact of Platelet Transfusion Therapy on 28-day Mortality in Septic Patients With Thrombocytopenia During ICU Stay: a Multicenter Retrospective Observational Study
Currently, there are no multicenter studies on platelet transfusion for SAT patients, and the benefits and risks of platelet transfusion still require further validation based on large-sample data. In summary, investigating the correlation between platelet transfusion during ICU stay and 28-day mortality in SAT patients, as well as evaluating the impact of platelet transfusion on bleeding, thrombotic events, and inflammation control, is of great significance for optimizing SAT management strategies. This study aims to analyze the effect of platelet transfusion on the prognosis of SAT patients, thereby providing an evidence-based foundation for clinical decision-making.
Read the detailed description
Sepsis is the most common cause of thrombocytopenia in intensive care unit (ICU) patients, with an incidence rate as high as 35%-59%. Severe thrombocytopenia (≤50×10⁹/L) accounts for 30% of cases, and the degree of thrombocytopenia is positively correlated with mortality risk [1-3]. Studies have shown that patients with sepsis-associated thrombocytopenia (SAT) not only experience prolonged ICU stays and mechanical ventilation duration but also have significantly increased rates of major bleeding events and renal replacement therapy. Meanwhile, the 28-day mortality rate rises with the severity of thrombocytopenia [4, 5]. Platelets play a dual role in sepsis: on one hand, they act as "innocent bystanders" reflecting disease severity; on the other hand, they participate in the pathological process through immune regulation and microvascular protection. For example, platelets contribute to host defense by facilitating neutrophil extracellular traps (NETs) formation mediated by Toll-like receptor 4 (TLR4), but a reduction in platelet count can lead to impaired endothelial barrier function, exacerbating organ edema and bleeding risk [6, 7]. Furthermore, dynamic changes in platelet morphological parameters, such as mean platelet volume (MPV) and platelet distribution width (PDW), are independently associated with inflammatory response and mortality, highlighting the importance of platelet function monitoring [8].
In clinical practice, the primary goal of exogenous platelet transfusion in SAT patients is to rapidly increase circulating platelet counts in cases of inadequate platelet production or excessive consumption, thereby reducing bleeding risk. Due to the complex mechanisms of thrombocytopenia in sepsis-including bone marrow suppression, peripheral consumption (e.g., disseminated intravascular coagulation (DIC), immune-mediated destruction), and splenic sequestration-endogenous platelet recovery is often delayed. Exogenous transfusion provides immediate platelet supplementation, particularly for patients with severe thrombocytopenia (≤50×10⁹/L) accompanied by bleeding tendencies or those requiring invasive procedures (e.g., surgery, central venous catheterization) [9]. Compared to endogenous platelet production (which typically takes 5-7 days), exogenous transfusion helps to rapidly correct hemostatic function, reduce the risk of spontaneous bleeding (such as gastrointestinal or intracranial bleeding); improve endothelial barrier function, decrease microvascular leakage, thereby alleviating organ edema and hypoxic injury; and provide platelets with immunomodulatory activity, potentially regulating excessive inflammatory responses through the release of anti-inflammatory factors (e.g., TGF-β, IL-10) [10, 11].
However, current treatment strategies for SAT remain controversial. Some studies indicate that platelet transfusion may increase in-hospital mortality, particularly in patients with severe thrombocytopenia (≤50×10⁹/L), where transfusion is associated with higher 28-day and 90-day mortality rates, along with risks such as transfusion reactions and alloimmunization [12, 13]. Potential mechanisms include: the inflammatory microenvironment in septic patients may cause rapid activation or destruction of transfused platelets, reducing transfusion efficacy; allogeneic platelets may carry pro-inflammatory mediators (e.g., mitochondrial DNA, high mobility group box 1 (HMGB1)), further exacerbating systemic inflammatory response; and transfusion-related complications, such as transfusion-related acute lung injury (TRALI), transfusion-associated circulatory overload (TACO), and alloimmune reactions, may contribute to adverse clinical outcomes [14, 15]. Additionally, recent studies have found that platelet function may be impaired in septic patients (e.g., increased glycoprotein Ibα (GPIbα) shedding), leading to reduced adhesion and aggregation capacity of transfused platelets and potentially worsening endothelial dysfunction [16].
Previous studies on platelet transfusion and outcomes in SAT patients were all based on database analyses. The results showed that platelet transfusion in septic patients with thrombocytopenia was associated with increased mortality [17, 18]. Currently, there are no multicenter studies on platelet transfusion specifically for SAT patients, and the benefits and risks of platelet transfusion still require further validation based on large-sample data.
In summary, investigating the correlation between platelet transfusion during ICU stay and 28-day mortality in SAT patients, as well as evaluating the impact of platelet transfusion on bleeding and thrombotic events and inflammation control, is of great significance for optimizing SAT management strategies. This study aims to analyze the effect of platelet transfusion on the prognosis of SAT patients, thereby providing an evidence-based foundation for clinical decision-making.
- Conditions
- Sepsis, Sepsis and Coagulopathy
- Being tested
- SAT patients
- Keywords
- Sepsis-Associated Thrombocytopenia, Platelet infusion, mortality, sepsis, platelet
- Medical subject headings
- Sepsis, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAT patientsOther
Whether or not the SAT patients received Platelet infusion
| Study group | Role | What they receive |
|---|---|---|
| Platelet Transfusion Group | Platelet Transfusion within 14 days after ICU admission Receives: Other: SAT patients | |
| No Platelet Transfusion Group | No Platelet Transfusion within 14 days after ICU admission Receives: Other: SAT patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU mortality
Survival status from ICU admission to discharge/transfer from the ICU.
Measured: Survival status from ICU admission to discharge/transfer from the ICU.
Secondary outcomes (5)
Bleeding events
Record newly occurring gastrointestinal bleeding, airway bleeding, epistaxis, oral bleeding, and subcutaneous bleeding within 28 days, based on records from the electronic medical record (EMR) or intensive care unit (ICU) information system
Measured: Within 28 days from ICU admission or at the time of ICU transfer/discharge.
Thrombotic events
Record deep vein thrombosis and pulmonary embolism occurring within 28 days, based on records from the electronic medical record (EMR) or intensive care unit (ICU) information system
Measured: Within 28 days from ICU admission or at the time of ICU transfer/discharge.
ICU length of stay within 28 days
Measured: within 28 days after ICU admission
Platelet transfusion therapy-related endpoints
Record dose-response relationship between platelet transfusion frequency/dosage and ICU mortality;Platelet counts on Day 1, Day 3, Day 5, and Day 7 after platelet transfusion.
Measured: Post-transfusion day 1, 3, 5, and 7
Laboratory indicator-related endpoints
Record the dynamic trajectory of platelet counts (e.g., recovery rate, duration of low values, fluctuation amplitude) based on laboratory results; Trends in platelet morphological parameters (MPV, PDW) and inflammatory markers (IL-6, CRP, PCT).
Measured: Post-transfusion day 1, 3, 5, and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start15 Nov 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical 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
- Retrospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07230067
- Sponsor's protocol ID
- NFEC-2025-392
- Status last verified
- Jan 2026
- First submitted
- 29 Aug 2025
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Platelet Transfusion Therapy on 28-day Mortality in Septic Patients With Thrombocytopenia During ICU Stay: a Multicenter Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT07230067
- Acronym / sponsor ID
- NFEC-2025-392
- Conditions
- Sepsis, Sepsis and Coagulopathy
- Keywords
- Sepsis-Associated Thrombocytopenia, Platelet infusion, mortality, sepsis, platelet
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 17 Nov 2025 (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.
Currently, there are no multicenter studies on platelet transfusion for SAT patients, and the benefits and risks of platelet transfusion still require further validation based on large-sample data. In summary, investigating the correlation between platelet transfusion during ICU stay and 28-day mortality in SAT patients, as well as evaluating the impact of platelet transfusion on bleeding, thrombotic events, and inflammation control, is of great significance for optimizing SAT management strategies. This study aims to analyze the effect of platelet transfusion on the prognosis of SAT patients, thereby providing an evidence-based foundation for clinical decision-making.
Detailed description
Sepsis is the most common cause of thrombocytopenia in intensive care unit (ICU) patients, with an incidence rate as high as 35%-59%. Severe thrombocytopenia (≤50×10⁹/L) accounts for 30% of cases, and the degree of thrombocytopenia is positively correlated with mortality risk [1-3]. Studies have shown that patients with sepsis-associated thrombocytopenia (SAT) not only experience prolonged ICU stays and mechanical ventilation duration but also have significantly increased rates of major bleeding events and renal replacement therapy. Meanwhile, the 28-day mortality rate rises with the severity of thrombocytopenia [4, 5]. Platelets play a dual role in sepsis: on one hand, they act as "innocent bystanders" reflecting disease severity; on the other hand, they participate in the pathological process through immune regulation and microvascular protection. For example, platelets contribute to host defense by facilitating neutrophil extracellular traps (NETs) formation mediated by Toll-like receptor 4 (TLR4), but a reduction in platelet count can lead to impaired endothelial barrier function, exacerbating organ edema and bleeding risk [6, 7]. Furthermore, dynamic changes in platelet morphological parameters, such as mean platelet volume (MPV) and platelet distribution width (PDW), are independently associated with inflammatory response and mortality, highlighting the importance of platelet function monitoring [8].
In clinical practice, the primary goal of exogenous platelet transfusion in SAT patients is to rapidly increase circulating platelet counts in cases of inadequate platelet production or excessive consumption, thereby reducing bleeding risk. Due to the complex mechanisms of thrombocytopenia in sepsis-including bone marrow suppression, peripheral consumption (e.g., disseminated intravascular coagulation (DIC), immune-mediated destruction), and splenic sequestration-endogenous platelet recovery is often delayed. Exogenous transfusion provides immediate platelet supplementation, particularly for patients with severe thrombocytopenia (≤50×10⁹/L) accompanied by bleeding tendencies or those requiring invasive procedures (e.g., surgery, central venous catheterization) [9]. Compared to endogenous platelet production (which typically takes 5-7 days), exogenous transfusion helps to rapidly correct hemostatic function, reduce the risk of spontaneous bleeding (such as gastrointestinal or intracranial bleeding); improve endothelial barrier function, decrease microvascular leakage, thereby alleviating organ edema and hypoxic injury; and provide platelets with immunomodulatory activity, potentially regulating excessive inflammatory responses through the release of anti-inflammatory factors (e.g., TGF-β, IL-10) [10, 11].
However, current treatment strategies for SAT remain controversial. Some studies indicate that platelet transfusion may increase in-hospital mortality, particularly in patients with severe thrombocytopenia (≤50×10⁹/L), where transfusion is associated with higher 28-day and 90-day mortality rates, along with risks such as transfusion reactions and alloimmunization [12, 13]. Potential mechanisms include: the inflammatory microenvironment in septic patients may cause rapid activation or destruction of transfused platelets, reducing transfusion efficacy; allogeneic platelets may carry pro-inflammatory mediators (e.g., mitochondrial DNA, high mobility group box 1 (HMGB1)), further exacerbating systemic inflammatory response; and transfusion-related complications, such as transfusion-related acute lung injury (TRALI), transfusion-associated circulatory overload (TACO), and alloimmune reactions, may contribute to adverse clinical outcomes [14, 15]. Additionally, recent studies have found that platelet function may be impaired in septic patients (e.g., increased glycoprotein Ibα (GPIbα) shedding), leading to reduced adhesion and aggregation capacity of transfused platelets and potentially worsening endothelial dysfunction [16].
Previous studies on platelet transfusion and outcomes in SAT patients were all based on database analyses. The results showed that platelet transfusion in septic patients with thrombocytopenia was associated with increased mortality [17, 18]. Currently, there are no multicenter studies on platelet transfusion specifically for SAT patients, and the benefits and risks of platelet transfusion still require further validation based on large-sample data.
In summary, investigating the correlation between platelet transfusion during ICU stay and 28-day mortality in SAT patients, as well as evaluating the impact of platelet transfusion on bleeding and thrombotic events and inflammation control, is of great significance for optimizing SAT management strategies. This study aims to analyze the effect of platelet transfusion on the prognosis of SAT patients, thereby providing an evidence-based foundation for clinical decision-making.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet Transfusion Group | – | Other: SAT patientsPlatelet Transfusion within 14 days after ICU admission |
| No Platelet Transfusion Group | – | Other: SAT patientsNo Platelet Transfusion within 14 days after ICU admission |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Meeting the Sepsis-3.0 diagnostic criteria and platelet count < 100 × 10⁹/L at ICU admission
Key inclusion criteria (5 listed)
- Patients admitted to the ICU between January 2021 and May 2024 and subsequently discharged
- Age ≥ 18 years
- Meeting the Sepsis-3.0 diagnostic criteria
- Platelet count < 100 × 10⁹/L at ICU admission
- ICU length of stay ≥ 48 hours
Key exclusion criteria (8 listed)
- Active bleeding (e.g., major gastrointestinal bleeding, intracranial hemorrhage) or hematologic malignancies (e.g., leukemia, myelodysplastic syndrome, lymphoma);
- Liver cirrhosis (Child-Pugh class B/C), chronic kidney disease (CKD stage 4-5), or autoimmune diseases (e.g., systemic lupus erythematosus);
- Receipt of chemotherapy, immunosuppressants (e.g., cyclosporine, rituximab), or hematopoietic stem cell/solid organ transplantation within 2 weeks;
- Pregnancy or lactation;
- Pre-existing chronic thrombocytopenia (baseline platelet count <100×10⁹/L for >1 month) or long-term use of antiplatelet/anticoagulant drugs (>2 weeks);
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 |
|---|---|---|
| SAT patientsWhether or not the SAT patients received Platelet infusion | Other | No Platelet Transfusion Group, Platelet Transfusion Group |
Primary outcome
ICU mortality
Time frame: Survival status from ICU admission to discharge/transfer from the ICU.
Survival status from ICU admission to discharge/transfer from the ICU.
5 secondary outcomes
Bleeding events
Time frame: Within 28 days from ICU admission or at the time of ICU transfer/discharge.
Thrombotic events
Time frame: Within 28 days from ICU admission or at the time of ICU transfer/discharge.
ICU length of stay within 28 days
Time frame: within 28 days after ICU admission
Platelet transfusion therapy-related endpoints
Time frame: Post-transfusion day 1, 3, 5, and 7
Laboratory indicator-related endpoints
Time frame: Post-transfusion day 1, 3, 5, and 7
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 30 Jan 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Sepsis and Coagulopathy, run by Nanfang Hospital, Southern Medical University at 1 site in China.
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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU mortality (time frame: Survival status from ICU admission to discharge/transfer from the ICU.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2026.