DRKS00014782
Completed
Not Applicable
Continuous vital sign monitoring (CVSM) with a mobile device in patients receiving intensive chemotherapy or allogenic/ autologous blood stemcell transplantation for the treatment of aggressive hematologic malignancies to identify algorithms that detect serious clinical complications - CoMMoD-CAST
niversitätsklinikum Düsseldorf0 sites79 target enrollmentMay 29, 2018
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- J18
- Sponsor
- niversitätsklinikum Düsseldorf
- Enrollment
- 79
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with acute leukemia, myelodysplastic or myeloproliferative syndromes, aggressive lymphoproliferative disorders or germ cell tumors requiring treatment with intensive chemotherapy, allogenic/ autologous blood stem cell transplantation
- •Application of an intensive (radio\-) chemotherapy protocol which is known to usually
- •induce hematotoxicity CTC \= III for a minimum of 7 days (ICE, DA, HAM, FluBu,
- •BuCy, FluTreo, FluTBI, B\-ALL, GMALL Kons I, ect.)
- •Age 18 years and able to understand design and objectives of the trial
- •Signed written informed consent and data safety agreement before any trial\-related
- •Willingness to continuously wear the CVSM device throughout the evaluation period
Exclusion Criteria
- •Medical or mental conditions (e.g. dementia) impairing the ability to continuously wear the CVSM device throughout the evaluation period
- •Active implants (e.g. pacemaker)
- •Tattoo on upper arm
- •Skin disease or defects on upper arm
- •Allergic to device or its components (e.g. synthetic fabrics)
- •Conditions which preclude wearing a device on upper arm (e.g. Shunt, active bleeding)
- •History of non\-functional Hemoglobin (sickle\-cell anemia, recent carbon monoxide intoxication)
- •Mental incapacity or language barriers which preclude adequate understanding or cooperation, known or suspected not to comply with trial directives or not to be reliable or trustworthy, or subject who in the opinion of the investigator should not participate in the trial
Outcomes
Primary Outcomes
Not specified
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