RecruitingNot Applicable

Sepsis-associated Thrombocytopenia and Platelet Transfusion （STAPT）

China1,500 participantsStarted 2025-11-15

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

ICU mortality

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

Trial details

NCT IDNCT07230067

SponsorNanfang Hospital, Southern Medical University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12-30

View on ClinicalTrials.gov More Sepsis trials