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.
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.
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.
Parallel
Administer Romiplostim treatment.
DrugAdminister 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.
Administer recombinant human thrombopoietin therapy
DrugAdminister 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.)
The effective rate of platelet-stimulating treatment after the 7th day
The effective rate of platelet-stimulating treatment after the 7th day
The time when platelet count first returned to ≥ 100×109/L
The time when platelet count first returned to ≥ 100×109/L
Platelet counts on the 3rd day, 7th day, 9th day, and 14th day
Platelet counts on the 3rd day, 7th day, 9th day, and 14th day
The mortality rate 28 days after treatment
The mortality rate 28 days after treatment
The incidence of bleeding events after treatment
The incidence of bleeding events after treatment
Length of stay in the ICU
Length of stay in the ICU
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Shanghai 10th People's Hospital
Lead sponsor
Shanghai Tongji Hospital, Tongji University School of Medicine
Collaborator
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