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

Sponsor
Shanghai 10th People's Hospital
Study ID
NCT07595133
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Sepsis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • Administer recombinant human thrombopoietin therapy — DRUG
    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.)

Study Details

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.

Key Dates

First listed
May 19, 2026
Start date
Jun 1, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
280 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: treatment group: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 volume as that of Romiplostim.
  • Active Comparator: 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.)

Primary Outcome Measure

The effective rate of platelet-stimulating treatment after the 7th day [ Time Frame: 7th day ]

Central Contacts

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