Platelet transfusion for adults with sepsis-associated thrombocytopenia

The Impact of Platelet Transfusion Therapy on 28-day Mortality in Septic Patients With Thrombocytopenia During ICU Stay: a Multicenter Retrospective Observational Study

This study will see if giving platelet transfusions to adults with sepsis-related low platelets changes 28-day survival, bleeding, clotting, or inflammation.

Quick facts

• Study type: Observational
• Enrollment: 1500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Nanfang Hospital, Southern Medical University (other)
• Drugs / interventions: rituximab, chemotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07230067 on ClinicalTrials.gov

What this trial studies

This is a retrospective observational analysis of adult ICU patients with sepsis-associated thrombocytopenia admitted between January 2021 and May 2024 at a tertiary hospital. Patients with platelet count <100×10^9/L and ICU stay ≥48 hours will be compared according to whether they received platelet transfusions during the ICU stay. The primary outcome is 28-day mortality, and secondary outcomes include major bleeding, thrombotic events, duration of mechanical ventilation, renal replacement therapy, and inflammatory and platelet morphology markers (e.g., MPV, PDW). The goal is to use large-sample real-world data to clarify associations between platelet transfusion and clinical outcomes to inform transfusion decisions in SAT patients.

Who should consider this trial

Good fit: Adults (≥18 years) admitted to the ICU with Sepsis-3 criteria, platelet count <100×10^9/L at ICU admission, and ICU length of stay ≥48 hours are the intended population.

Not a fit: Patients with active major bleeding, hematologic malignancy, advanced liver or kidney disease, pregnancy/lactation, pre-existing chronic thrombocytopenia, or recent chemotherapy/immunosuppression are excluded and unlikely to benefit from these results.

Why it matters

Potential benefit: If results show benefit or harm, they could help clinicians decide when platelet transfusion improves survival or reduces complications in sepsis-associated thrombocytopenia.

How similar studies have performed: Prior observational studies link low platelet counts to worse sepsis outcomes, but large-sample data specifically on platelet transfusion effects are limited and randomized evidence is lacking.

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).

Where this trial is running

Guangzhou, Guangdong

• Nanfang Hospital， Southern Medical University — Guangzhou, Guangdong, China (RECRUITING)

Conditions: Sepsis, Sepsis and Coagulopathy, Sepsis-Associated Thrombocytopenia, Platelet infusion, mortality, sepsis, platelet