A Multicenter Clinical Study of Romiplostim N01 in the Treatment of Sepsis-related Thrombocytopenia (ITJ(QN)2510)
12 mai 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
280
Phase
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Qian Wu
- Numéro de téléphone: +86 13535056114
- E-mail: 295022395@qq.com
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
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.
|
|
Comparateur actif: 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.) |
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.) |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The effective rate of platelet-stimulating treatment after the 7th day
Délai: 7th day
|
The effective rate of platelet-stimulating treatment after the 7th day
|
7th day
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The time when platelet count first returned to ≥ 100×109/L
Délai: 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
Délai: 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
Délai: 28 days
|
The mortality rate 28 days after treatment
|
28 days
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The incidence of bleeding events after treatment
Délai: 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
Délai: through study completion, an average of 1 month
|
Length of stay in the ICU
|
through study completion, an average of 1 month
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 juin 2026
Achèvement primaire (Estimé)
31 décembre 2027
Achèvement de l'étude (Estimé)
31 décembre 2027
Dates d'inscription aux études
Première soumission
21 mars 2026
Première soumission répondant aux critères de contrôle qualité
12 mai 2026
Première publication (Réel)
19 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
19 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
12 mai 2026
Dernière vérification
1 mars 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- SHTJH-2026015
- 80,000 yuan (Autre subvention/numéro de financement: Shanghai Tongji Hospital)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .