Platelet TransfusionNCT03814486
Retrospective Descriptive Study of Platelet Transfusion in Patients With Palliative Hematologic Malignancies at the University Hospital of Besançon
An observational study of Platelet Transfusion and Palliative Care, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Platelet Transfusion, Palliative Care
- What is being tested?
- descriptive
- How many people
- 119 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2017to 1 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Platelet Transfusion, Palliative Care
- Being tested
- descriptive
- Keywords
- platelet transfusion, palliative care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
descriptiveOther
evaluate in number and efficacy platelet transfusion at the end of life, demographic characteristic are also noted
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: descriptive |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 18 month (between 07/01/2015 and 12/31/2016)
Secondary outcomes (1)
demographic characteristic
characteristic of patient (age, diagnosis,location of death, palliative care received...)
Measured: 18 months (between 07/01/2015 and 12/31/2016)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start1 Jul 2017
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Platelet TransfusionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- regis aubry, ph, Study director, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03814486
- Sponsor's protocol ID
- J Moracchini
- Status last verified
- Dec 2018
- First submitted
- 2 Jan 2019
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: patient were dead during the period of recruitment. Characteristic of patient could be used for other purpose
Publications
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.
PubMed 23208312Sherbeck 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.
PubMed 27550559Salacz 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.
PubMed 17298272Lassauniere 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.
PubMed 8857246Boggs 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.
PubMed 2414307Wang 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.
PubMed 29285557
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude Descriptive Retrospective de la Transfusion Plaquettaire Chez Des Patients Atteints d'hémopathie Maligne en Phase Palliative et Suivis au CHU de Besançon
- ClinicalTrials.gov ID
- NCT03814486
- Acronym / sponsor ID
- J Moracchini
- Conditions
- Platelet Transfusion, Palliative Care
- Keywords
- platelet transfusion, palliative care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 24 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient transfused in platelet in the 6 last months of life | – | Other: descriptivepatient 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| descriptiveevaluate in number and efficacy platelet transfusion at the end of life, demographic characteristic are also noted | Other | patient transfused in platelet in the 6 last months of life |
Primary outcome
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.
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
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
1 secondary outcome
demographic characteristic
Time frame: 18 months (between 07/01/2015 and 12/31/2016)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Background: PubMed 23208312Hochsmann 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.
- Background: PubMed 27550559Sherbeck 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.
- Background: PubMed 17298272Salacz 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.
- Background: PubMed 8857246Lassauniere 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.
- Background: PubMed 2414307Boggs 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.
- Results publication: PubMed 29285557Wang 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.
- Individual participant dataSharing planned: Undecided. patient were dead during the period of recruitment. Characteristic of patient could be used for other purpose
Related trials for Platelet Transfusion
Not yet recruitingObservational study
Platelet Transfusion Thresholds in Non-Bleeding Patients
Non Bleeding Patients With Thrombocytopenia
RecruitingObservational study
Role of Viscoelastometric Testing in the Development and Validation of a Clinical-biological Score for Predicting Bleeding in Patients With Malignant Haematological Disorders and Severe Thrombocytopenia
Thrombocytopenia, Platelet Transfusion
Active, not recruitingObservational study
Mechanisms of Anaphylaxis
Anaphylaxis, Allergy
Active, not recruitingPhase 2
Study of Efficacy and Safety of Eltrombopag in Lower-risk MDS Patients With Platelet Transfusion Dependence
Myelodysplastic Syndromes
RecruitingPhase 2/3
Autologous Cold-stored Apheresis Platelets
Bleeding, Platelets
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
regis aubry, ph study director
Centre Hospitalier Universitaire de Besancon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Platelet Transfusion and Palliative Care, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate frequency of platelet transfusion at the end of life (time frame: 18 months (between 07/01/2015 and 12/31/2016)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03814486, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2019.