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

Multiple Myeloma Clinical Trial

— ALHERT  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06409767
• Other study ID #: 49RC23_0425
• Secondary ID: ID-RCB
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 15, 2024
• Est. completion date: January 15, 2028

Study information

• Verified date: May 2024
• Source: University Hospital, Angers
• Contact: Corentin Orvain, MD PhD
• Phone: 02 41 35 36 37
• Email: Corentin.Orvain[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2224
• Est. completion date: January 15, 2028
• Est. primary completion date: October 15, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Leukemia
• Lymphoma
• Multiple Myeloma

Intervention

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.

Locations

Country	Name	City	State
France	Centre Hospitalier Amiens-Picardie	Amiens
France	Centre Hospitalier Universitaire d'Angers	Angers
France	Centre Hospitalier Universitaire Besancon	Besançon
France	Centre Hospitalier Universitaire Brest	Brest
France	Centre Hospitalier universitaire Nancy	Nancy
France	Centre Hospitalier Universitaire Nantes	Nantes
France	Centre Hospitalier Universitaire poitiers	Poitiers
France	centre Hospitalier Universitaire Rennes	Rennes
France	centre Hospitalier Universitaire Saint etienne	Saint-Étienne
France	centre Hospitalier Universitaire Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hazard Ratio associated with the type of care in a Cox model explaining the time to occurrence of the composite criterion: in-hospital mortality or initiation of organ support.	Hazard Ratio (and its 95% confidence interval) associated with the type of care (control or interventional) in a Cox model explaining the time to occurrence of the composite criterion: in-hospital mortality or initiation of organ support (invasive mechanical ventilation, vasopressors [Noradrenaline, Dobutamine or Adrenaline], renal replacement therapy, extracorporeal circulation [ECMO]).; It will assess the impact of of the implementation of the NEWS with ICU admission in case of a NEWS = 7, in patients with hematological malignancies receiving intensive chemotherapy.	3 months