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Clinical Trials/DRKS00014782
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.

Registry
who.int
Start Date
May 29, 2018
End Date
February 29, 2020
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
niversitätsklinikum Düsseldorf

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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