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Safety and Feasibility of a Multidisciplinary Programme of Integrated Hospital-home Management With Early Discharge of Patients With Haematological Malignancies Undergoing High-dose Chemotherapy in Hospital

RecruitingNAAges 18 Years - 75 YearsAllIRCCS Azienda Ospedaliero-Universitaria di Bologna
NCT06814405 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Patients undergoing particular intensive and (sub)myeloablative chemotherapy regimens with subsequent autologous stem cell transplant currently have a relatively low rate of therapy-related complications, both infectious and non-infectious (organ damage), and can therefore benefit from a specific multidisciplinary care programme at home. In this clinical context, early discharge and domicile of the patient after therapy provided in a hospital setting may represent a procedure designed to better intercept the patient's personal needs. In addition, it may make it possible to increase the limited availability of beds in the face of the progressive increase in demand, allowing the provision of hospital therapies to a higher number of patients with a consequent reduction in pre-hospital waiting times.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Diagnosis of haematological malignancy undergoing high-dose chemotherapy (sub- or myeloablative) * Age between 18-75 years * WHO Performance Status \< 2 or Karnofsky ≥ 60% * Adequate organ function: * FE≥ 50% and absence of significant electrocardiographic changes * eVFG \> 40 ml/min and/or creatinine ≤ 1.6 mg/dl (CPK-EPI formula) * total bilirubin ≤ 3 mg/ml * AST/ALT ≤ 5 ULN * SpO2 ≥ 94% * Reinfusion ≥ 2x106 CD34+/Kg * Presence of a 24-hour SARS-COV-2 vaccinated caregiver * Home \< 45 minutes' drive from hospital * Informed consent obtained Exclusion Criteria: * Diagnosis of haematological malignancy at onset or in progression * Significant cardiovascular disease: heart failure NYHA class 3 or 4, uncontrolled angina, history of myocardial infarction, unstable angina or stroke in the previous 6 months, uncontrolled hypertension, significant arrhythmias not controlled by medication
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What it tests

  • Home patient management
  • Hospital patient management
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Where

1 site
IRCCS-AOU di Bologna
Bologna, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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