Sepsis-associated Thrombocytopenia and Platelet Transfusion （STAPT）

NCT07230067 | Recruiting

• 1 other identifier: NFEC-2025-392
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Sepsis and Coagulopathy

Keywords

Sepsis-Associated Thrombocytopenia; Platelet infusion; mortality; sepsis; platelet

Outcome Measures

Primary Outcomes (1)

• ICU mortality

  Survival status from ICU admission to discharge/transfer from the ICU.

  Survival status from ICU admission to discharge/transfer from the ICU.

Secondary Outcomes (5)

• Bleeding events

  Within 28 days from ICU admission or at the time of ICU transfer/discharge.

• Thrombotic events

  Within 28 days from ICU admission or at the time of ICU transfer/discharge.

• ICU length of stay within 28 days

  within 28 days after ICU admission

• Platelet transfusion therapy-related endpoints

  Post-transfusion day 1, 3, 5, and 7

• Laboratory indicator-related endpoints

  Post-transfusion day 1, 3, 5, and 7

Study Arms (2)

Platelet Transfusion Group

Platelet Transfusion within 14 days after ICU admission

Other: SAT patients

No Platelet Transfusion Group

No Platelet Transfusion within 14 days after ICU admission

Other: SAT patients

Interventions

SAT patients OTHER

Whether or not the SAT patients received Platelet infusion

No Platelet Transfusion Group; Platelet Transfusion Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Meeting the Sepsis-3.0 diagnostic criteria and platelet count \< 100 × 10⁹/L at ICU admission

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital， Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Sepsis; Hemostatic Disorders

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: November 17, 2025
• Study Start: November 15, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)