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A Multicenter Clinical Study of Romiplostim N01 in the Treatment of Sepsis-related Thrombocytopenia (ITJ(QN)2510)

12 maj 2026 uppdaterad av: Sheng Wang MD PhD, Shanghai 10th People's Hospital
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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

280

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Läkemedel: 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.
Aktiv komparator: 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.)
Läkemedel: 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.)

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
The effective rate of platelet-stimulating treatment after the 7th day
Tidsram: 7th day
The effective rate of platelet-stimulating treatment after the 7th day
7th day

Sekundära resultatmått

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

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
The incidence of bleeding events after treatment
Tidsram: through study completion, an average of 1 month
The incidence of bleeding events after treatment
through study completion, an average of 1 month
Length of stay in the ICU
Tidsram: through study completion, an average of 1 month
Length of stay in the ICU
through study completion, an average of 1 month

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Shanghai 10th People's Hospital

Samarbetspartners

Shanghai Tongji Hospital, Tongji University School of Medicine

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 juni 2026

Primärt slutförande (Beräknad)

31 december 2027

Avslutad studie (Beräknad)

31 december 2027

Studieregistreringsdatum

Först inskickad

21 mars 2026

Först inskickad som uppfyllde QC-kriterierna

12 maj 2026

Första postat (Faktisk)

19 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

19 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

12 maj 2026

Senast verifierad

1 mars 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • SHTJH-2026015
  • 80,000 yuan (Annat bidrag/finansieringsnummer: Shanghai Tongji Hospital)

Plan för individuella deltagardata (IPD)

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