Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT07230067
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07230067
Study Brief:
Protocol Section:
NCT07230067