A Multicenter Clinical Study of Romiplostim N01 in the Tr... | NCT07595133

NCT07595133

Protocol Section

Identification Module

Results Section

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Annotation Section

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Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
80,000 yuan	Other Grant/Funding Number	Shanghai Tongji Hospital

Status Module

Name	Class
Shanghai Tongji Hospital, Tongji University School of Medicine	OTHER

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
treatment group:Administer Romiplostim treatment	Experimental	Administer Romiplostim treatment. Romiplostim for injection N01 (specification: 250 μg per vial) is administered subcutaneously, 250 μg, once a week (since the risk of bleeding in patients with sepsis is high and the included patients have a platelet count of < 50 × 109/L, the starting dose is 4 μg/kg as per the instructions), administered on the first day; a saline solution is used as the placebo, and the administration is repeated for 6 days after the first administration, with the same volume as that of Romiplostim.	Drug: Administer Romiplostim treatment.
Administer recombinant human thrombopoietin therapy	Active Comparator	Administer recombinant human thrombopoietin therapy. Thrombopoietin injection (specification: 15000 U/mL) is administered subcutaneously, 15000 U each time, once a day, for a continuous period of ≥1 week. If PLT ≥ 100×109/L, the medication is suspended. If PLT ≤ 10×109/L or there is a significant bleeding tendency, machine-processed platelets are transfused and enhanced hemostasis treatment is provided. (Notes: Both groups of patients were informed of the administration frequency and method.)	Drug: Administer recombinant human thrombopoietin therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Administer Romiplostim treatment.	Drug	Administer Romiplostim treatment. Romiplostim for injection N01 (specification: 250 μg per vial) is administered subcutaneously, 250 μg, once a week (since the risk of bleeding in patients with sepsis is high and the included patients have a platelet count of < 50 × 109/L, the starting dose is 4 μg/kg as per the instructions), administered on the first day; a saline solution is used as the placebo, and the administration is repeated for 6 days after the first administration, with the same volume as that of Romiplostim.

Outcomes Module

Measure	Description	Time Frame
The effective rate of platelet-stimulating treatment after the 7th day	The effective rate of platelet-stimulating treatment after the 7th day	7th day

Secondary Outcomes

Measure	Description	Time Frame
The time when platelet count first returned to ≥ 100×109/L	The time when platelet count first returned to ≥ 100×109/L	up to 2 weeks
Platelet counts on the 3rd day, 7th day, 9th day, and 14th day

Other Outcomes

Measure	Description	Time Frame
The incidence of bleeding events after treatment	The incidence of bleeding events after treatment	through study completion, an average of 1 month
Length of stay in the ICU	Length of stay in the ICU

Eligibility Module

Eligibility Criteria

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.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Feb 12, 2026	Mar 21, 2026	Prot_SAP_000.pdf
ICF	No	No	Yes	Informed Consent Form	Feb 2, 2026	Mar 21, 2026	ICF_001.pdf

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes