Impact of an Early Warning System on the Prognosis of Patients With Hematological Malignancies Receiving Intensive Chemotherapy With or Without Hematopoietic Cell Transplantation.

Official title

Impact of an Early Warning System on the Prognosis of Patients With Hematological Malignancies Receiving Intensive Chemotherapy With or Without Hematopoietic Cell Transplantation, a Multicenter Cluster Randomized Study

Overview

Patients with hematologic malignancies requiring intensive chemotherapy are at risk for life-threatening complications. Organ failure may appear rapidly and delay in initiating life-sustaining interventions may result in increased mortality. This encourages great alertness although not all patients require close monitoring. It is therefore critical to identify which patients are the most at risk for clinical deterioration to consider increased surveillance in these patients. The benefit of early intensive care unit (ICU) admission, as soon as the first signs of organ dysfunction appear, must also be clarified. Such an intervention could increase survival of patients by close monitoring and early initiation of organ-specific interventions but could also be responsible for anxiety and increased use of ICU resources. Many teams have analyzed the impact of early warning systems (EWS) including vital signs to detect organ dysfunction early on. It has been shown that these EWS could positively impact survival in many medical fields (pre-hospital, medicine or surgery departments). A few retrospective studies have explored the impact of EWS in hematology, with overall good prediction for ICU admission and mortality. Until now, it has however not been formally demonstrated that early ICU admission, as soon as the first signs of organ dysfunction appear, could benefit patients with hematologic malignancies. A randomized controlled trial studying the impact of early intervention would clarify the role of such a strategy. In this study, the investigators will prospectively evaluate the implementation of the National Early Warning Score (NEWS), with systematic referral to the ICU in high-score patients, to improve the survival of patients receiving intensive chemotherapy in ten academic centers. This score is one of the most performant and most frequently used to predict organ failure. Its calculation only requires vital signs such as respiratory rate, peripheral oxygen saturation, need for oxygen therapy, body temperature, arterial pressure, heart rate, and level of consciousness. The investigators will therefore study the impact of ICU admission in patients with high NEWS in a randomized, controlled trial. A cluster randomization is planned in which the centers will be randomized between usual care (control group) and interventional care with transfer to the ICU in the event of a NEWS score ≥7 (interventional group). Each parameter used to calculate the NEWS will be collected at least three times a day by the attending nurse.

Interventions

• Other Real-time calculation of the NEWS with ICU admission if NEWS ≥ 7.
  The calculation of NEWS requires vital signs such as respiratory rate, peripheral oxygen saturation, need for oxygen therapy, body temperature, arterial pressure, heart rate, and level of consciousness. Each parameter used to calculate the NEWS will be collected least three times a day by the attending nurse.

Primary outcome measures

• In-hospitality mortality and/or inition of organ support [Time frame: 3 months]

Secondary outcome measures (4)

• Relative weight of each parameter used to calculate the NEWS for predicting the risk of organ failure requiring life-sustaining organ support [Time frame: 3 months]
• Feasibility of implementing early warning scores in routine practice [Time frame: 3 months]
• To assess quality of life of patients according to treatment arm. [Time frame: 3 months]
• economic evaluation [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

• Adult patient
• Hospitalization in a protected unit of a hematology department for induction therapy of acute myeloid leukemia or acute lymphoblastic leukemia induction, intensive chemotherapy with autologous hematopoietic cell transplantation, allogeneic hematopoietic cell transplantation
• Expected length of stay in the hematology department of at least 7 days
• Patient with social security
• Signed informed consent form

Exclusion criteria

• Decision of care limitation with decision not to transfer to ICU or not initiate organ support
• Pregnant, parturient or breastfeeding woman
• Person deprived of liberty by judicial or administrative decision
• Person under forced psychiatric care
• Person under legal protection
• Person unable to express consent
• Hospitalization for Chimeric Antigenic Receptor (CAR) T-cell therapy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

France · 10 centers

• Centre Hospitalier Amiens-Picardie — Amiens
• Centre Hospitalier Universitaire d'Angers — Angers
• Centre Hospitalier Universitaire Besancon — Besançon
• Centre Hospitalier Universitaire Brest — Brest
• Centre Hospitalier universitaire Nancy — Nancy
• Centre Hospitalier Universitaire Nantes — Nantes
• Centre Hospitalier Universitaire poitiers — Poitiers
• centre Hospitalier Universitaire Saint etienne — Saint-Etienne
• … and 2 more centers

Publications

• Taillantou-Candau M, Kouatchet A, Darsonval A, Monmousseau F, Darras E, Schmidt A, Riou J, Orvain C. 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. BMJ Open. 2026 Mar 19;16(3):e113466. doi: 10.1136/bmjopen-2025-11346 PMID 41856593

Identifiers

NCT: NCT06409767 · 49RC23_0425 · ID-RCB

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗