Role of Viscoelastometric Testing in the Development and Validation of a Clinical-biological Score for Predicting Bleeding in Patients With Malignant Haematological Disorders and Severe Thrombocytopenia (VISCOTHEM-2)
The goal of this single-center, non-controlled, non-randomized exploratory clinical trial is To develop and validate a clinical-biological score (VISCOTHEM score) incorporating viscoelastometric tests parameters; based on an association study, and to establish a threshold that enables the prediction of the immediate risk of bleeding in haematology patients with severe thrombocytopenia (<20 G/L); with a view to selecting a population with a residual risk of bleeding of zero (NPV ≥ 95%, to achieve a residual probability of bleeding < 5%).
The score may incorporate variables identified in the literature as having a plausible causal relationship with the occurrence of bleeding (14,15), as well as viscoelastometric tests parameters, conventional haemostasis parameters and relevant clinical parameters. .
Participants will undergo an additional blood sample to standard care. The total volume of blood drawn will be 21.1 mL. The following analyses will be performed: Quantra®, Rotem®, blood count, platelets, immature platelet count, plasma prothrombin time, activated partial thromboplastin time, International Normalized Ratio, fibrinogen, urea, creatinin, albumin.
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Marion GHIDI
- 電話番号：+33450637031
- メール：mghidi@ch-annecygenevois.fr
参加基準
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
サンプリング方法
調査対象母集団
The patients included will be selected from the entire cohort of patients with haematological malignancies:
- those admitted to the haematology day unit for treatment or assessment,
- or patients admitted to the haematology inpatient ward,
- or patients being monitored in the haematology outpatient clinic.
説明
Inclusion Criteria:
- Adult patients;
- Who have been informed about the study and have freely given their informed consent to participate in the study;
- With a malignant haematological disorder or bone marrow failure, whether treated or untreated and at any stage of treatment;
- With central thrombocytopenia strictly below 20 G/L in a blood sample taken less than 72 hours ago and not having received a transfusion since;
- Admitted to a haematology day unit or inpatient ward, or being followed up at a haematology outpatient clinic;
- With or without active bleeding;
- Affiliated with or covered by a social security scheme.
Exclusion Criteria:
- Patients who have received at least one of the following treatments:
- Antiplatelet agents within 7 days prior to enrolment,
- Vitamin K antagonists within 7 days prior to enrolment,
- Direct oral anticoagulants within 72 hours prior to enrolment,
- Low molecular weight heparin within 24 hours prior to inclusion,
- Unfractionated heparin within 6 hours prior to inclusion,
- Bruton's tyrosine kinase inhibitor (ibrutinib, zanubrutinib or acalabrutinib) within 72 hours prior to inclusion;
- Patients with a history of thrombopathy;
- Patients with a history of haemostatic disorders carrying a risk of haemorrhage or thrombosis;
- Thrombocytopenia associated with immune thrombocytopenic purpura or disseminated intravascular coagulation;
- Patients already enrolled in the study;
- Pregnant or breastfeeding women;
- Patients under guardianship or curatorship;
- Patients who do not understand French;
- Patients under judicial protection.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Intervention (additional blood sample)
|
A blood sample will be taken from all patients included in the study.
This blood sampling is an added act of the study.
It will be performed as soon as possible after inclusion in the study.
The total volume of blood drawn will be 21.1 mL.
The following analyses will be performed: Quantra®, Rotem®, blood count, platelets, immature platelet count, plasma prothrombin time, activated partial thromboplastin time, International Normalized Ratio, fibrinogen, Urea, Creatinine, Albumin.
|
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 |
|---|---|---|
|
Identification of factors associated with bleeding among clinical and laboratory parameters
時間枠：At baseline, before platelet transfusion
|
Clinical parameters : Age, Sex, BMI, systolic and diastolic blood pressure, presence of mucositis, presence of a lesion with haemorrhagic potential, bleeding within the previous 5 days, fever associated with an infection or an episode of febrile neutropenia, transplant within the previous 100 days Laboratory parameters : viscoelastic test parameters, white blood cell count, Haemoglobin, Platelet and immature platelet counts, Urea, Creatinine, Albumin, Standard haemostasis (APTT, INR, Fibrinogen)
|
At baseline, before platelet transfusion
|
|
Apply a multivariate regression model to develop the VISCOTHEM score for predicting immediate bleeding (WHO score ≥ 1), based on the coefficients of the factors associated with bleeding
時間枠：At baseline, before platelet transfusion
|
At baseline, before platelet transfusion
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Stratification and comparison of performance and score calibration depending on whether the viscoelastic test result is obtained using ROTEM® or Quantra®.
時間枠：At baseline, before platelet transfusion
|
To propose a score capable of processing a viscoelastic test result from either ROTEM® or Quantra®,
|
At baseline, before platelet transfusion
|
|
Describe the presence of bleeding according to the WHO classification (WHO score ≥1) and WHO bleeding grade, where applicable
時間枠：72 hours after blood sample
|
72 hours after blood sample
|
|
|
Describe the presence of platelet transfusion
時間枠：72 hours after blood sample
|
72 hours after blood sample
|
|
|
Describe the Vital status or loss of follow-up, where applicable
時間枠：72 hours after blood sample
|
72 hours after blood sample
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 24-10
- 2026-A00535-46 (その他の識別子：ID-RCB (ANSM))
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?
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
米国FDA規制機器製品の研究
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Additional blood sampleの臨床試験
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University of UtahAlbert Einstein College of Medicine; University of California, San Francisco; National Human Genome... と他の協力者完了新生児スクリーニング
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Ischemia Care LLC完了虚血性脳卒中 | 心房細動 | 血栓性脳卒中 | 一過性脳虚血発作 | 心塞栓性脳卒中 | 脳底動脈の脳卒中 | 一過性脳血管イベントアメリカ
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Applied Science & Performance Institute完了
-
Bedford Hospital NHS TrustAnglia Ruskin Universityわからない