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

What Was Tested

This registered phase 1 trial tested Romiplostim.

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.

It had two arms (groups): treatment group:Administer Romiplostim treatment (experimental) and Administer recombinant human thrombopoietin therapy (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 280 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age ≥ 18 years old, gender unrestricted. 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.

The full record lists 4 inclusion and 15 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

The participants were allocated by chance, so the Romiplostim group and the comparison group should start out alike.

The Romiplostim group and the comparison group ran side by side rather than switching.

As a double-blind Romiplostim study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2026-06-01 with completion listed for 2027-12-31.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 3 secondary outcomes, for example The time when platelet count first returned to ≥ 100×109/L, Platelet counts on the 3rd day, 7th day, 9th day, and 14th day and The mortality rate 28 days after treatment.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Romiplostim in 280 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Romiplostim compound page, all human trials.