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Prophylactic Platelet transfusion Requirement in Sepsis-associated Thrombocytopenia Optimization

Study on personalized blood transfusion strategy and mechanism for sepsis-related cytopenia based on biomarkers and clinical practice

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111584
Enrollment
Unknown
Registered
2025-11-03
Start date
2025-11-05
Completion date
Unknown
Last updated
2025-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Interventions

High threshold:Prophylactic platelet transfusion is administered when the platelet count reaches the threshold (also called the trigger value or indication) of <=50×10^9/L.
Low threshold:Prophylactic platelet transfusion is administered when the platelet count reaches the threshold (also called the trigger value or indication) of <=20×10^9/L.
(Exploration of red blood cell transfusion markers based on proteomics) Control group:None
(Exploration of red blood cell transfusion markers based on proteomics) Sepsis group Non-transfusion group:None
(Proteomics-based exploration of red blood cell transfusion markers) Sepsis group with intermediate transfusion threshold (Hb 7.0-9.0 g/dL):None
(Exploration of red blood cell transfusion markers based on proteomics) Sepsis group with intermediate transfusion threshold (Hb < 7.0 g/dL):None
(Translational basic research) control group:None
(Translational Basic Research) Low Threshold Group:None
(Translational Basic Research) High Threshold Group:None

Sponsors

The Third People's Hospital of Chengdu
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Exploration of Red Blood Cell Transfusion Markers Based on ProteomicsPatients:aged >=18 years, meeting Sepsis-3 diagnosis, in medical, surgical, and cardiac surgery departments with Hb levels greater than 9 g/dL, Hb =18 years; (2) Admitted to the Intensive Care Unit (ICU); (3) Diagnosed with sepsis (according to Sepsis-3 criteria: presence of confirmed or suspected infection, and an acute change in total SOFA score >=2 points), and platelet count =18 years, meeting Sepsis-3 diagnosis in medical or emergency ICU, with platelet count =18 years; (3) Platelet count <=50×10^9/L within the past 6 hours; (4) Meeting Sepsis-3.0 diagnostic criteria; (5) Informed consent signed by a legally authorized representative.

Exclusion criteria

Exclusion criteria: Proteomics-based exploration of red blood cell transfusion markers Patients with massive bleeding, patients with known chronic blood system diseases, cancer patients undergoing chemotherapy or radiotherapy, patients with terminal diseases who have given up active treatment, patients with severe liver failure, patients who have received blood transfusion treatment in the recent period (3 months), and pregnant women. Retrospective study 1. Patients who died within 2 days after admission to the ICU or were discharged voluntarily without following the doctor's advice; 2. Pregnant or breastfeeding; 3. Patients with active bleeding or postoperative status; 4. Patients receiving dialysis, extracorporeal circulation or extracorporeal membrane oxygenation (ECMO); 5. Patients with a history of organ transplantation or receiving immunosuppressive therapy; 6. Patients using antiplatelet drugs; 7. Patients with non-sepsis-related thrombocytopenia, including: immune thrombocytopenia (patients who received platelet transfusion within 3 weeks before enrollment should be tested for platelet antibodies), hereditary thrombocytopenia, thrombotic thrombocytopenic purpura, hemolytic uremic syndrome, drug-related thrombocytopenia (such as ITP, HIT, PTP), and malignancy-related thrombocytopenia. Translational basic research 1. Patients who died within 2 days after admission to the ICU or were discharged voluntarily without following the doctor's advice; 2. Pregnant or breastfeeding patients; 3. Patients with active bleeding or postoperative status; 4. Patients receiving dialysis, extracorporeal circulation, or extracorporeal membrane oxygenation (ECMO); 5. Patients with a history of organ transplantation or receiving immunosuppressive therapy; 6. Patients using antiplatelet drugs; 7. Patients with non-sepsis-related thrombocytopenia, including: immune thrombocytopenia (patients who received platelet transfusion within 3 weeks before enrollment should be tested for platelet antibodies), hereditary thrombocytopenia, thrombotic thrombocytopenic purpura, hemolytic uremic syndrome, drug-related thrombocytopenia (such as ITP, HIT, PTP), and malignancy-related thrombocytopenia. Randomized controlled trials 1.Patients whose medical decisions are not suitable for participation in the study (patients with critical conditions, patients who died or were transferred out of the ICU within 48 hours, patients who had previously experienced serious adverse reactions to blood products, patients who had received organ transplants or were taking immunosuppressants, patients with immunodeficiency, etc.). 2.Pregnancy and lactation. 3.After differential diagnosis, other possible causes of thrombocytopenia cannot be ruled out except for thrombocytopenia caused by infection: active bleeding in the past 72 hours, surgery, extracorporeal circulation or ECMO use in the past ten days, immune thrombocytopenia (platelet antibody testing for patients who received platelet transfusions within 3 weeks before enrollment), hereditary thrombocytopenia, thrombotic thrombocytopenic purpura, hemolytic uremic syndrome, drug-induced thrombocytopenia (ITP, HIT, PTP), and thrombocytopenia related to malignant tumors. 4.Special infections: severe fever with thrombocytopenia syndrome (SFTS) virus infection. 5.Long-term use of antiplatelet drugs before admission.

Design outcomes

Primary

MeasureTime frame
28d all-cause mortality;90d all-cause mortality;

Secondary

MeasureTime frame
PIICS onset rate;

Countries

China

Contacts

Public ContactYunhong Yu

The Third People's Hospital of Chengdu

1136929270@qq.com+86 139 8011 0975

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026