NCT07230067 Sepsis-associated Thrombocytopenia and Platelet Transfusion (STAPT)
| NCT ID | NCT07230067 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nanfang Hospital, Southern Medical University |
| Condition | Sepsis |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2025-11-15 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,500 participants in total. It began in 2025-11-15 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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).
Frequently Asked Questions
Who can join the NCT07230067 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sepsis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07230067 currently recruiting?
Yes, NCT07230067 is actively recruiting participants. Visit ClinicalTrials.gov or contact Nanfang Hospital, Southern Medical University to inquire about joining.
Where is the NCT07230067 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07230067 clinical trial?
NCT07230067 is sponsored by Nanfang Hospital, Southern Medical University. The trial plans to enroll 1,500 participants.