A Multicenter Clinical Study of Romiplostim N01 in the Treatment of Sepsis-related Thrombocytopenia (ITJ(QN)2510)
2026年5月12日 更新者：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.
調査の概要
状態
まだ募集していません
条件
研究の種類
介入
入学 (推定)
280
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Qian Wu
- 電話番号：+86 13535056114
- メール：295022395@qq.com
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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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.
|
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アクティブコンパレータ：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.) |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The effective rate of platelet-stimulating treatment after the 7th day
時間枠：7th day
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The effective rate of platelet-stimulating treatment after the 7th day
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7th day
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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The time when platelet count first returned to ≥ 100×109/L
時間枠：up to 2 weeks
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The time when platelet count first returned to ≥ 100×109/L
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up to 2 weeks
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Platelet counts on the 3rd day, 7th day, 9th day, and 14th day
時間枠：3rd day, 7th day, 9th day, and 14th day
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Platelet counts on the 3rd day, 7th day, 9th day, and 14th day
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3rd day, 7th day, 9th day, and 14th day
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The mortality rate 28 days after treatment
時間枠：28 days
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The mortality rate 28 days after treatment
|
28 days
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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The incidence of bleeding events after treatment
時間枠：through study completion, an average of 1 month
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The incidence of bleeding events after treatment
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through study completion, an average of 1 month
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Length of stay in the ICU
時間枠：through study completion, an average of 1 month
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Length of stay in the ICU
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through study completion, an average of 1 month
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月1日
一次修了 (推定)
2027年12月31日
研究の完了 (推定)
2027年12月31日
試験登録日
最初に提出
2026年3月21日
QC基準を満たした最初の提出物
2026年5月12日
最初の投稿 (実際)
2026年5月19日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月19日
QC基準を満たした最後の更新が送信されました
2026年5月12日
最終確認日
2026年3月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- SHTJH-2026015
- 80,000 yuan (その他の助成金/資金番号：Shanghai Tongji Hospital)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
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