Sepsis-associated Thrombocytopenia and Platelet Transfusion （STAPT）

NCT ID: NCT07230067

Last Updated: 2026-01-30

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-11-15
• Study Completion Date: 2027-03-31

Brief 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. 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.

Conditions

Sepsis; Sepsis and Coagulopathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Platelet Transfusion Group

Platelet Transfusion within 14 days after ICU admission

SAT patients

Intervention Type: OTHER

Whether or not the SAT patients received Platelet infusion

No Platelet Transfusion Group

No Platelet Transfusion within 14 days after ICU admission

SAT patients

Intervention Type: OTHER

Whether or not the SAT patients received Platelet infusion

Interventions

SAT patients

Whether or not the SAT patients received Platelet infusion

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nanfang Hospital， Southern Medical University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Lulan Li, Ph.D

Role: primary

lilulanlilulan@163.com

86-13631309571

Zhenhua Zeng, Ph.D

Role: backup

zhenhuazeng.2008@163.com

86-15692428912

Other Identifiers

NFEC-2025-392

Identifier Type: -

Identifier Source: org_study_id