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

NCT06409767 | Recruiting

• 2 other identifiers: 49RC23_0425ID-RCB
• Study Type: interventional
• Target: 2,224
• Locations: 1 country
• Sites: 10

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.

Conditions

Leukemia; Lymphoma; Multiple Myeloma

Keywords

Intensive chemotherapy; hematopoietic cell transplantation; early ICU admission

Outcome Measures

Primary Outcomes (1)

• In-hospitality mortality and/or inition of organ support

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

  3 months

Secondary Outcomes (4)

• Relative weight of each parameter used to calculate the NEWS for predicting the risk of organ failure requiring life-sustaining organ support

  3 months

• Feasibility of implementing early warning scores in routine practice

  3 months

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

  3 months

• economic evaluation

  3 months

Study Arms (2)

Interventional arm

EXPERIMENTAL

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

Control arm

NO INTERVENTION

Interventions

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.

Interventional arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (10)

Centre Hospitalier Amiens-Picardie

Amiens, 80054, France

RECRUITING

Centre Hospitalier Universitaire d'Angers

Angers, 49933, France

RECRUITING

Centre Hospitalier Universitaire Besancon

Besançon, 25030, France

RECRUITING

Centre Hospitalier Universitaire Brest

Brest, 29609, France

RECRUITING

Centre Hospitalier universitaire Nancy

Nancy, 45011, France

RECRUITING

Centre Hospitalier Universitaire Nantes

Nantes, 44093, France

RECRUITING

Centre Hospitalier Universitaire poitiers

Poitiers, 86021, France

RECRUITING

centre Hospitalier Universitaire Saint etienne

Saint-Etienne, 42270, France

RECRUITING

centre Hospitalier Universitaire Strasbourg

Strasbourg, 67098, France

NOT YET RECRUITING

centre Hospitalier Universitaire Tours

Tours, 37044, France

RECRUITING

MeSH Terms

Conditions

Leukemia; Lymphoma; Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Central Study Contacts

Corentin Orvain, MD PhD

CONTACT

02 41 35 36 37; Corentin.Orvain@chu-angers.fr

Aurélie Hautefort

CONTACT

02 41 35 36 37; DRCI-Promotion-Interne@chu-angers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Cluster randomized trial

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 10, 2024
• Study Start: April 10, 2025
• Primary Completion (Estimated): April 11, 2028
• Study Completion (Estimated): July 11, 2028
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (10)