A Multicenter Clinical Study of Romiplostim N01 in the Treatment of Sepsis-related Thrombocytopenia

Inclusion criteria

• Age ≥ 18 years old, gender unrestricted.
• Meeting the diagnostic criteria of sepsis 3.0, namely: a) confirmed or suspected infection; b) organ dysfunction caused by infection, that is, Sequential Organ Failure Assessment (SOFA) score ≥ 2 points. If organ dysfunction is known to exist before infection, that is, the SOFA score is greater than 0 points, then the SOFA score must increase by ≥ 2 points after the infection occurs.
• Platelet count ≤ 50×109/L.
• The subjects must fully understand and be able to comply with the requirements of the research protocol, and voluntarily sign the informed consent form.

Exclusion criteria

• Subjects who are allergic to romiplostim N01 or thrombopoietin, or who have previously received romiplostim N01 or thrombopoietin treatment but showed no therapeutic effect.
• Subjects who have undergone cardiopulmonary resuscitation or have end-stage liver or kidney failure.
• Subjects with thrombocytopenia caused by hematological diseases, or with other hypercoagulable state diseases, recent thrombosis, or acute active bleeding.
• Subjects who have participated in other drug clinical studies within one month.
• Subjects who have used anticoagulants or antiplatelet drugs (such as aspirin, clopidogrel, etc.) within three weeks.
• Subjects who have received platelet-raising treatment (such as methylprednisolone, platelet transfusion, intravenous immunoglobulin or TPO antirheumatic drugs) within two weeks.
• Subjects who have received immunomodulatory agent treatment within six months.
• Subjects who have undergone splenectomy within six months.
• Subjects with a history of radiotherapy or chemotherapy for malignant tumors or with advanced malignant tumors.
• Subjects who have previously received allogeneic stem cell transplantation or organ transplantation.
• Subjects with severe cardiovascular and cerebrovascular diseases, severe trauma, major surgery, or other causes of major bleeding.
• Subjects who were transferred out or died within 24 hours of admission (or ICU).
• Subjects with known or suspected immunosuppression history, including invasive opportunistic infection history (such as histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis); or subjects with complex long-term infections.
• Women who are currently pregnant or breastfeeding, or plan to become pregnant or breastfeed during the study; and men whose partners plan to become pregnant during the study.
• Subjects whom the investigator deems unsuitable for participation in this study for any other reason.