Platelet TransfusionR-PLQNCT03806712
Comprehensive Study of Social Representation of Platelet Transfusion in Patients Followed for Advanced Hematological Malignancies (R-PLQ)
An observational study of Platelet Transfusion and Hematological Malignancy, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Platelet Transfusion, Hematological Malignancy, Palliative Care
- What is being tested?
- multi method questionary (developped by De Rosa, in 1995 and 2014)
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2019to 22 Jul 2019
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with advanced hematological malignancies, transfused in platelet regulary, hematologist's nurses who practice platelet transfusion and hematologist who prescribe the transfusion.
Who may be able to join
- 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.
Who cannot join
- minor patient
- non communicant patient
- non transfused platelet patient
- non voluntary patient or hematologist or nurses
- non graduated hematologist
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- multi method questionary (developped by De Rosa, in 1995 and 2014)
- Keywords
- social representation
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multi method questionary (developped by De Rosa, in 1995 and 2014)Other
questions from an association network according to the subject and the grounded theorise (Glasser and Strauss)
| Study group | Role | What they receive |
|---|---|---|
| patient | patient with advanced, non curative hematological malignancies multi method questionary, at least 1 hour per patient Receives: Other: multi method questionary (developped by De Rosa, in 1995 and 2014) | |
| hematologist | medical practitioner of platelet transfusion multi method questionary, at least 1 hour per hematologist Receives: Other: multi method questionary (developped by De Rosa, in 1995 and 2014) | |
| Nurses | nurses working in hematology, practicing platelet transfusion multi method questionary, at least 1 hour per nurse Receives: Other: multi method questionary (developped by De Rosa, in 1995 and 2014) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start1 Apr 2019
- Primary completion1 Jun 2019
- Study completion22 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Other
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03806712
- Sponsor's protocol ID
- P/2019/413
- Acronym
- R-PLQ
- Status last verified
- Jul 2019
- First submitted
- 30 Dec 2018
- Last updated
- 25 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: interview will be registered then transcribe on professional computer ans accessible only by the investigator and collaborators.
Publications
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.
PubMed 18810505McGrath 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. doi: 10.1111/j.1365-2354.2006.00745.x.
PubMed 17371426Jeoffrion C, Dupont P, Tripodi D, Roland-Levy C. [Social representations of illness: Comparison of "expert" knowledge and "naive" knowledge]. Encephale. 2016 Jun;42(3):226-33. doi: 10.1016/j.encep.2015.12.007. Epub 2016 Jan 12. French.
PubMed 26796561
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Study of Social Representation of Platelet Transfusion in Patients Followed for Advanced Hematological Malignancies (R-PLQ)
- ClinicalTrials.gov ID
- NCT03806712
- Acronym / sponsor ID
- R-PLQ / P/2019/413
- Keywords
- social representation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 22 Jul 2019 (actual)
- First posted
- 16 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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patient | – | Other: multi method questionary (developped by De Rosa, in 1995 and 2014)patient with advanced, non curative hematological malignancies multi method questionary, at least 1 hour per patient |
| hematologist | – | Other: multi method questionary (developped by De Rosa, in 1995 and 2014)medical practitioner of platelet transfusion multi method questionary, at least 1 hour per hematologist |
| Nurses | – | Other: multi method questionary (developped by De Rosa, in 1995 and 2014)nurses working in hematology, practicing platelet transfusion multi method questionary, at least 1 hour per nurse |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with advanced hematological malignancies, transfused in platelet regulary, hematologist's nurses who practice platelet transfusion and hematologist who prescribe the transfusion.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- minor patient
- non communicant patient
- non transfused platelet patient
- non voluntary patient or hematologist or nurses
- non graduated hematologist
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 |
|---|---|---|
| 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) | Other | Nurses, hematologist, patient |
Primary outcome
measure the impact of social representation on platelet transfusion practice
Time frame: 3 months
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.
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 25 Jul 2019.
- Background: PubMed 18810505McGrath 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.
- Background: PubMed 17371426McGrath 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. doi: 10.1111/j.1365-2354.2006.00745.x.
- Background: PubMed 26796561Jeoffrion C, Dupont P, Tripodi D, Roland-Levy C. [Social representations of illness: Comparison of "expert" knowledge and "naive" knowledge]. Encephale. 2016 Jun;42(3):226-33. doi: 10.1016/j.encep.2015.12.007. Epub 2016 Jan 12. French.
- Individual participant dataSharing planned: No. interview will be registered then transcribe on professional computer ans accessible only by the investigator and collaborators.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hematological Malignancy, 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 5 inclusion and 5 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 25 Jul 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?
measure the impact of social representation on platelet transfusion practice (time frame: 3 months). 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 NCT03806712, which also lists 3 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 25 Jul 2019.