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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03806712
Other study ID # P/2019/413
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2019
Est. completion date July 22, 2019

Study information

Verified date July 2019
Source Centre Hospitalier Universitaire de Besancon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Limited data is available for end of life care in hematologic malignancies, moreover with thrombocytopenic patients. Thrombopenia is a frequent complication, specific of bone marrow involvement in those diseases or its treatments. Yet, a few studies was interested in, whereas platelet transfusion is the only treatment indicated. As it represent a scarce, limited resource, the ethical principles are in conflict in this setting and there's a lack of recommendation. The final decision is take by the clinician and his patient, but no study exist in representation of the two parts. We provide a qualitative study to understand what this decision is made of.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date July 22, 2019
Est. primary completion date June 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria:

- major patient

- patient with advanced hematological malignancies

- patient transfused in platelet regularly (3 time at least in last month)

- medical practioner, hematologist, prescribing platelet transfusion at least one per week.

- nurse working in hematology, practicing platelet transfusion at lest one peer week.

Exclusion Criteria:

- minor patient

- non communicant patient

- non transfused platelet patient

- non voluntary patient or hematologist or nurses

- non graduated hematologist

Study Design


Intervention

Other:
multi method questionary (developped by De Rosa, in 1995 and 2014)
questions from an association network according to the subject and the grounded theorise (Glasser and Strauss)

Locations

Country Name City State
France Moracchini Besançon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

References & Publications (3)

Jeoffrion C, Dupont P, Tripodi D, Roland-Lévy C. [Social representations of illness: Comparison of "expert" knowledge and "naïve" knowledge]. Encephale. 2016 Jun;42(3):226-33. doi: 10.1016/j.encep.2015.12.007. Epub 2016 Jan 12. French. — View Citation

McGrath P, Holewa H. Special considerations for haematology patients in relation to end-of-life care: Australian findings. Eur J Cancer Care (Engl). 2007 Mar;16(2):164-71. — View Citation

McGrath P, Leahy M. Catastrophic bleeds during end-of-life care in haematology: controversies from Australian research. Support Care Cancer. 2009 May;17(5):527-37. doi: 10.1007/s00520-008-0506-1. Epub 2008 Sep 23. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary measure the impact of social representation on platelet transfusion practice inner core and peripheral items of platelet transfusion of each participant will be collected until reaching saturation, it's to say that the repetition of some terms will be measured between each interview thank's to a questionnaire of at least two principals opened questions. 3 months
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