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

Обзор

This study intends to randomly divide the SAT patients admitted to the ICU into the ropivacaine N01 treatment group and the recombinant human thrombopoietin control group. By measuring the platelet count of the SAT patients, the therapeutic effect of ropivacaine N01 will be evaluated. Moreover, through the APACHE II score of the patients, the improvement of platelet technology, the 28-day mortality rate, the incidence of adverse reactions, the length of ICU stay and the hospitalization cost, the advantages and social value of ropivacaine N01 in treating SAT will be explored.

Вмешательства

• Препарат Administer Romiplostim treatment.
  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 volum
• Препарат Administer recombinant human thrombopoietin therapy
  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.)

Первичные конечные точки

• The effective rate of platelet-stimulating treatment after the 7th day [Срок оценки: 7th day]

Вторичные конечные точки (3)

• The time when platelet count first returned to ≥ 100×109/L [Срок оценки: up to 2 weeks]
• Platelet counts on the 3rd day, 7th day, 9th day, and 14th day [Срок оценки: 3rd day, 7th day, 9th day, and 14th day]
• The mortality rate 28 days after treatment [Срок оценки: 28 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07595133 · SHTJH-2026015 · 80,000 yuan

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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