Trial Title:
Impact of an Early Warning System on the Prognosis of Patients With Hematological Malignancies Receiving Intensive Chemotherapy With or Without Hematopoietic Cell Transplantation.
NCT ID:
NCT06409767
Condition:
Leukemia
Lymphoma
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Hematologic Neoplasms
Conditions: Keywords:
Intensive chemotherapy
hematopoietic cell transplantation
early ICU admission
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Real-time calculation of the NEWS with ICU admission if NEWS ≥ 7.
Description:
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.
Arm group label:
Interventional arm
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Hospitalier Amiens-Picardie
Address:
City:
Amiens
Zip:
80054
Country:
France
Contact:
Last name:
Delphine LEBON, PhD
Phone:
03 22 45 59 14
Phone ext:
+33
Email:
lebon.delphine@chu-amiens.fr
Facility:
Name:
Centre Hospitalier Universitaire d'Angers
Address:
City:
Angers
Zip:
49933
Country:
France
Contact:
Last name:
Corentin Orvain, PhD
Phone:
02 41 35 44 75
Phone ext:
+33
Email:
corentin.orvain@chu-angers.fr
Facility:
Name:
Centre Hospitalier Universitaire Besancon
Address:
City:
Besançon
Zip:
25030
Country:
France
Contact:
Last name:
Yohan Desbrosses, PhD
Phone:
03 81 66 82 32
Phone ext:
+33
Email:
ydesbrosses@chu-besancon.fr
Facility:
Name:
Centre Hospitalier Universitaire Brest
Address:
City:
Brest
Zip:
29609
Country:
France
Contact:
Last name:
Marie-Anne Couturier, PhD
Phone:
02 98 22 30 37
Email:
marie-anne.couturier@chu-brest.fr
Facility:
Name:
Centre Hospitalier universitaire Nancy
Address:
City:
Nancy
Zip:
45011
Country:
France
Contact:
Last name:
Caroline Bonmati, PhD
Phone:
03 83 15 32 82
Phone ext:
+33
Email:
c.bonmati@chru-nancy.fr
Facility:
Name:
Centre Hospitalier Universitaire Nantes
Address:
City:
Nantes
Zip:
44093
Country:
France
Contact:
Last name:
Pierre Peterlin, PhD
Phone:
02 40 08 32 71
Email:
pierre.peterlin@chu-nantes.fr
Facility:
Name:
Centre Hospitalier Universitaire poitiers
Address:
City:
Poitiers
Zip:
86021
Country:
France
Contact:
Last name:
Maria-Pilar Gallego-Hernanz, PhD
Phone:
05 49 44 43 07
Phone ext:
+33
Email:
maria-pilar@gallego-hernanz@chupoitiers.fr
Facility:
Name:
centre Hospitalier Universitaire Rennes
Address:
City:
Rennes
Zip:
35033
Country:
France
Contact:
Last name:
Jean-Baptiste Mear, PhD
Phone:
02 99 28 42 91
Phone ext:
+33
Email:
jean-baptiste.mear@chu-rennes.fr
Facility:
Name:
centre Hospitalier Universitaire Saint etienne
Address:
City:
Saint-Étienne
Zip:
42270
Country:
France
Contact:
Last name:
Emmanuelle Tavernier, PhD
Phone:
04 77 91 70 60
Email:
Emmanuelle.Tavernier@chu-stetienne.fr
Facility:
Name:
centre Hospitalier Universitaire Tours
Address:
City:
Tours
Zip:
37044
Country:
France
Contact:
Last name:
Alban Villate, PhD
Phone:
02 47 47 37 12
Phone ext:
+33
Email:
a.villate@chu-tours.fr
Start date:
October 15, 2024
Completion date:
January 15, 2028
Lead sponsor:
Agency:
University Hospital, Angers
Agency class:
Other
Source:
University Hospital, Angers
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06409767
