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NCT Number: NCT06409767

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Amiens-Picardie, Amiens, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Real-time calculation of the NEWS with ICU admission if NEWS ≥ 7.

Other

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 outcomes

  1. In-hospitality mortality and/or inition of organ support

    Time frame: 3 months

    In-hospital mortality and/or initiation of organ support (invasive mechanical ventilation, vasopressors [Epinephrin, Dobutamine or Adrenaline], renal replacement therapy, extracorporeal circulation [ECMO]).

Secondary outcomes

  1. 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

    Cox proportional hazards model with shared fragility to explain the occurrence over time of one or more organ support. The model's explanatory variables will be the different parameters used to calculate the NEWS.

  2. Feasibility of implementing early warning scores in routine practice

    Time frame: 3 months

    Proportion of patients with NEWS ≥7 effectively admitted to the ICU in the investigational arm.

  3. To assess quality of life of patients according to treatment arm.

    Time frame: 3 months

    Quality of life scores measured by the EQ-5D-5L questionnaire at days 0, 30, and 90 will be analyzed using linear mixed models (LMM) to account for repeated measures, for both the overall score and each dimension (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression).

  4. economic evaluation

    Time frame: 3 months

    Cost-utility analysis will estimate the incremental cost utility ratio (ICUR) in cost per quality-adjusted life year (QALY) gained and cost-effectiveness analysis will estimate the incremental cost effectiveness ratio (ICER) in cost per life year gained.

Study contacts

Contact information is provided by the study sponsor or research team.

Aurélie Hautefort

CONTACT

[email protected]

02 41 35 36 37 ext. +33

Corentin Orvain, MD PhD

CONTACT

[email protected]

02 41 35 36 37 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study 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

Acronym: ALHERT

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 10, 2024
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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