Using a NEWS early warning score to prompt ICU admission for adults receiving intensive chemotherapy or stem cell transplant
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
This trial tests whether real-time monitoring with the NEWS early warning score and prompt ICU admission (NEWS ≥ 7) helps adults with leukemia, lymphoma, or multiple myeloma who are receiving intensive chemotherapy or a hematopoietic cell transplant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2224 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Angers Government |
| Drugs / interventions | chemotherapy |
| Locations | 10 sites (Amiens and 9 other locations) |
| Trial ID | NCT06409767 on ClinicalTrials.gov |
What this trial studies
In this interventional study, clinical teams calculate the National Early Warning Score (NEWS) in real time for adults hospitalized in protected hematology units for induction therapy of acute leukemias or for intensive chemotherapy with autologous or allogeneic hematopoietic cell transplantation. The protocol calls for prompt ICU admission when a patient’s NEWS reaches or exceeds 7 to allow earlier organ-specific interventions and closer monitoring. Outcomes such as survival, timing of organ support, ICU use, and patient-centered effects will be compared between the NEWS-driven pathway and usual monitoring. The study also monitors for potential downsides, including increased ICU resource use and patient anxiety resulting from earlier transfers.
Who should consider this trial
Good fit: Adults hospitalized in a protected hematology unit for induction therapy for acute myeloid or lymphoblastic leukemia, or for intensive chemotherapy with autologous or allogeneic hematopoietic cell transplantation, with an expected stay of at least seven days and able to provide informed consent.
Not a fit: Patients with a prior decision limiting ICU transfer or organ support, those admitted for CAR T‑cell therapy, pregnant or breastfeeding women, and people unable to give consent are not expected to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could increase survival by enabling earlier detection of organ failure and faster initiation of life‑support measures.
How similar studies have performed: Early warning systems using vital signs have been studied by multiple teams and can detect deterioration earlier, but their effect on survival specifically in hematologic cancer patients is still unclear.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Amiens and 9 other locations
- Centre Hospitalier Amiens-Picardie — Amiens, France (Recruiting)
- Centre Hospitalier Universitaire d'Angers — Angers, France (Recruiting)
- Centre Hospitalier Universitaire Besancon — Besançon, France (Recruiting)
- Centre Hospitalier Universitaire Brest — Brest, France (Recruiting)
- Centre Hospitalier universitaire Nancy — Nancy, France (Recruiting)
- Centre Hospitalier Universitaire Nantes — Nantes, France (Recruiting)
- Centre Hospitalier Universitaire poitiers — Poitiers, France (Recruiting)
- centre Hospitalier Universitaire Saint etienne — Saint-Etienne, France (Recruiting)
- centre Hospitalier Universitaire Strasbourg — Strasbourg, France (Not_yet_recruiting)
- centre Hospitalier Universitaire Tours — Tours, France (Recruiting)
Study contacts
- Study coordinator: Corentin Orvain, MD PhD
- Email: Corentin.Orvain@chu-angers.fr
- Phone: 02 41 35 36 37
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.