Retrospective Descriptive Study of Platelet Transfusion in Patients With Palliative Hematologic Malignancies at the University Hospital of Besançon

January 28, 2019 updated by: Centre Hospitalier Universitaire de Besancon

Etude Descriptive Retrospective de la Transfusion Plaquettaire Chez Des Patients Atteints d'hémopathie Maligne en Phase Palliative et Suivis au CHU de Besançon

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

119

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France, 25000
        • Moracchini

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
evaluate in number and efficacy platelet transfusion at the end of life, demographic characteristic are also noted

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluate frequency of platelet transfusion at the end of life
Time Frame: 18 months (between 07/01/2015 and 12/31/2016)
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
Time Frame: 18 months (between 07/01/2015 and 12/31/2016)
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
Time Frame: 18 month (between 07/01/2015 and 12/31/2016)
to calculate the transfusional interval between 2 platelet transfusion in days
18 month (between 07/01/2015 and 12/31/2016)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
demographic characteristic
Time Frame: 18 months (between 07/01/2015 and 12/31/2016)
characteristic of patient (age, diagnosis,location of death, palliative care received...)
18 months (between 07/01/2015 and 12/31/2016)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Investigators

  • Study Director: regis aubry, ph, CENTRE HOSPITALIER UNIVERSITAIRE de BESANCON

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

January 2, 2019

First Submitted That Met QC Criteria

January 22, 2019

First Posted (Actual)

January 24, 2019

Study Record Updates

Last Update Posted (Actual)

January 30, 2019

Last Update Submitted That Met QC Criteria

January 28, 2019

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • J Moracchini

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

patient were dead during the period of recruitment. Characteristic of patient could be used for other purpose

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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