BMJ open · 2026
Impact of an early warning system on the outcome of patients with haematological malignancies receiving high-dose chemotherapy with or without haematopoietic cell transplantation: a protocol of the ALHERT cluster randomised trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод пока не подготовлен
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Taillantou-Candau Mathilde, Kouatchet Achille, Darsonval Astrid, Monmousseau Fanny, Darras Elise, Schmidt Aline, Riou Jérémie, Orvain Corentin
Аннотация
INTRODUCTION: Patients with haematological malignancies undergoing intensive chemotherapy with or without haematopoietic cell transplantation (HCT) are at high risk of complications that may require intensive care. While some studies advocate for early admission of these patients to the intensive care unit (ICU), it has not been formally demonstrated that admission to the ICU as soon as patients have organ injury may improve their outcomes. To demonstrate the efficacy of implementing the National Early Warning System (NEWS) with immediate ICU admission for patients with NEWS ≥7 to decrease hospital mortality and organ failure.
METHODS AND ANALYSIS: ALHERT is a randomised cluster, controlled trial carried out in 10 French centres. With their informed consent, adult patients undergoing induction therapy for acute lymphoblastic or myeloblastic leukaemia, autologous or allogeneic HCT in one of the participating centres will be included. Five centres will follow local guidelines for ICU admission (control group) while five centres will assess the NEWS at least three times per day with immediate ICU admission for patients with NEWS ≥7 (interventional group). The primary outcome is hospital mortality without organ sustaining therapy. Secondary objectives will be to study the relative weight of each parameter used to calculate the NEWS for predicting the risk of organ failure requiring life-sustaining organ support, to evaluate the feasibility of implementing early warning scores in routine practice by analysing the proportion of patients with NEWS ≥7 effectively admitted to the ICU in the investigational arm, to assess quality of life with EQ-5D-5L (five level European Quality of Life five Dimensions) and assess the cost-effectiveness of this strategy.
ETHICS AND DISSEMINATION: The protocol has been approved by the Comité de Protection des Personnes Ile de France I (Ethics Review ID-RCB: 2024-A00969-38). It is carried out in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. The findings of this study will be presented in peer-reviewed journals and at scientific conferences.
TRIAL REGISTRATION NUMBER: NCT06409767.
METHODS AND ANALYSIS: ALHERT is a randomised cluster, controlled trial carried out in 10 French centres. With their informed consent, adult patients undergoing induction therapy for acute lymphoblastic or myeloblastic leukaemia, autologous or allogeneic HCT in one of the participating centres will be included. Five centres will follow local guidelines for ICU admission (control group) while five centres will assess the NEWS at least three times per day with immediate ICU admission for patients with NEWS ≥7 (interventional group). The primary outcome is hospital mortality without organ sustaining therapy. Secondary objectives will be to study the relative weight of each parameter used to calculate the NEWS for predicting the risk of organ failure requiring life-sustaining organ support, to evaluate the feasibility of implementing early warning scores in routine practice by analysing the proportion of patients with NEWS ≥7 effectively admitted to the ICU in the investigational arm, to assess quality of life with EQ-5D-5L (five level European Quality of Life five Dimensions) and assess the cost-effectiveness of this strategy.
ETHICS AND DISSEMINATION: The protocol has been approved by the Comité de Protection des Personnes Ile de France I (Ethics Review ID-RCB: 2024-A00969-38). It is carried out in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. The findings of this study will be presented in peer-reviewed journals and at scientific conferences.
TRIAL REGISTRATION NUMBER: NCT06409767.