NCT03814486

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2019

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 24, 2019

Completed
Last Updated

January 30, 2019

Status Verified

December 1, 2018

Enrollment Period

1 year

First QC Date

January 2, 2019

Last Update Submit

January 28, 2019

Conditions

Keywords

platelet transfusionpalliative care

Outcome Measures

Primary Outcomes (3)

  • 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)

  • 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)

  • 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 Outcomes (1)

  • demographic characteristic

    18 months (between 07/01/2015 and 12/31/2016)

Study Arms (1)

patient transfused in platelet in the 6 last months of life

patient with hematological malignancies follow or hospitalised at least once in CHU of Besancon died in the period of the study transfused at least once in the 6 months of life

Other: descriptive

Interventions

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

patient transfused in platelet in the 6 last months of life

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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 and dead during the period of the study

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moracchini

Besançon, 25000, France

Location

Related Publications (6)

  • Hochsmann 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.

    PMID: 23208312BACKGROUND
  • 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.

    PMID: 27550559BACKGROUND
  • Salacz ME, Lankiewicz MW, Weissman DE. Management of thrombocytopenia in bone marrow failure: a review. J Palliat Med. 2007 Feb;10(1):236-44. doi: 10.1089/jpm.2006.0126.

    PMID: 17298272BACKGROUND
  • 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.

    PMID: 8857246BACKGROUND
  • Boggs DR. Jehovah's Witnesses with leukemia. Hosp Pract (Off Ed). 1985 Mar 15;20(3):92, 94-5, 98 passim. doi: 10.1080/21548331.1985.11703015. No abstract available.

    PMID: 2414307BACKGROUND
  • 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.

Study Officials

  • regis aubry, ph

    Centre Hospitalier Universitaire de Besancon

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2019

First Posted

January 24, 2019

Study Start

July 1, 2017

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

January 30, 2019

Record last verified: 2018-12

Locations