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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03814486
Other study ID # J Moracchini
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2017
Est. completion date July 1, 2018

Study information

Verified date December 2018
Source Centre Hospitalier Universitaire de Besancon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Development of palliative care is less effective for patients with hematologic malignancies. Limited data is available for end of life care in this population, 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.

The purpose of this study was to describe retrospectively platelet transfusion in the six last few month of life of patients with hematologic malignancies at the CHU of Besançon (France) between 01/07/15 and 31/12/16.


Recruitment information / eligibility

Status Completed
Enrollment 119
Est. completion date July 1, 2018
Est. primary completion date July 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patient with hematological malignancies

- transfused in platelet at least once in the last 6 months of life

- hospitalised or follow up at the CHU of Besancon at least once

- dead during the period of the study

Exclusion Criteria:

- patient with other oncologic malignancies

- not transfused in platelet in the last 6 months of life

- never hospitalised or follow up at the CHU of Besancon

- alive

Study Design


Related Conditions & MeSH terms


Intervention

Other:
descriptive
evaluate in number and efficacy platelet transfusion at the end of life, demographic characteristic are also noted

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 (6)

Boggs DR. Jehovah's Witnesses with leukemia. Hosp Pract (Off Ed). 1985 Mar 15;20(3):92, 94-5, 98 passim. — View Citation

Höchsmann B, Moicean A, Risitano A, Ljungman P, Schrezenmeier H. Supportive care in severe and very severe aplastic anemia. Bone Marrow Transplant. 2013 Feb;48(2):168-73. doi: 10.1038/bmt.2012.220. Epub 2012 Dec 3. Review. — View Citation

Lassauniere JM, Bertolino M, Hunault M, Zittoun R, Verspieren P, Moh-Klaren J, Jaulmes D, Colombat P. Platelet transfusions in advanced hematological malignancies: a position paper. J Palliat Care. 1996 Spring;12(1):38-41. — View Citation

Salacz ME, Lankiewicz MW, Weissman DE. Management of thrombocytopenia in bone marrow failure: a review. J Palliat Med. 2007 Feb;10(1):236-44. Review. — View Citation

Sherbeck JP, Boss RD. Ethical Questions about Platelet Transfusions at the End of Life. AMA J Ethics. 2016 Aug 1;18(8):764-70. doi: 10.1001/journalofethics.2016.18.8.ecas1-1608. — View Citation

Wang WS, Ma JD, Nelson SH, Revta C, Buckholz GT, Mulroney C, Roeland EJ. Transfusion practices at end of life for hematopoietic stem cell transplant patients. Support Care Cancer. 2018 Jun;26(6):1927-1931. doi: 10.1007/s00520-017-4023-y. Epub 2017 Dec 28. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary evaluate frequency of platelet transfusion at the end of life to calculate the number of platelet transfusion at the end of life. The number of platelet transfusion between 6 months and death are collected in each periods of 2 weeks to calculate the number of transfusion per patient during each 2 weeks. 18 months (between 07/01/2015 and 12/31/2016)
Primary evaluate efficacy of prophylactic platelet transfusion at the end of life to calculate the platelet yield in percentage 18 months (between 07/01/2015 and 12/31/2016)
Primary evaluate efficacy of non prophylactic platelet transfusion at the end of life to calculate the transfusional interval between 2 platelet transfusion in days 18 month (between 07/01/2015 and 12/31/2016)
Secondary demographic characteristic characteristic of patient (age, diagnosis,location of death, palliative care received...) 18 months (between 07/01/2015 and 12/31/2016)
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