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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06409767
Acronym
ALHERT
Enrollment
2224
Registered
2024-05-10
Start date
2025-04-10
Completion date
2028-07-11
Last updated
2025-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Lymphoma, Multiple Myeloma

Keywords

Intensive chemotherapy, hematopoietic cell transplantation, early ICU admission

Brief summary

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

OTHERReal-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.

Sponsors

University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Cluster randomized trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
In-hospitality mortality and/or inition of organ support3 monthsIn-hospital mortality and/or initiation of organ support (invasive mechanical ventilation, vasopressors \[Epinephrin, Dobutamine or Adrenaline\], renal replacement therapy, extracorporeal circulation \[ECMO\]).

Secondary

MeasureTime frameDescription
Relative weight of each parameter used to calculate the NEWS for predicting the risk of organ failure requiring life-sustaining organ support3 monthsCox 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.
Feasibility of implementing early warning scores in routine practice3 monthsProportion of patients with NEWS ≥7 effectively admitted to the ICU in the investigational arm.
To assess quality of life of patients according to treatment arm.3 monthsQuality 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).
economic evaluation3 monthsCost-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.

Countries

France

Contacts

Primary ContactCorentin Orvain, MD PhD
Corentin.Orvain@chu-angers.fr02 41 35 36 37
Backup ContactAurélie Hautefort
DRCI-Promotion-Interne@chu-angers.fr02 41 35 36 37

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026