Tissue and Organ ProcurementNCT01213069
Staff Opinions and Knowledge Concerning Organ and Tissue Harvesting: an Investigation Among the Patient Care Personnel in the South-Mediterranean Region of France
An observational study of Tissue and Organ Procurement, run by Centre Hospitalier Universitaire de Nīmes at 4 sites in France.
Trial summary
The goal of this study is to evaluate the knowledge of paramedical and medical care personnel concerning organ and tissue donations, as well as their opinions on this activity. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Tissue and Organ Procurement
- What is being tested?
- Questionnaires
- How many people
- 1,859 participants
- Where
- 4 sitesFrance
- Study dates
- Mar 2010to Jul 2012
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Health care personnel in South-Mediterranean France
Who may be able to join
- paramedical or medical care personnel from a participating center
- participates in organ donor activities
- works in a department with organ donor activity
Who cannot join
- personnel with no contact with organ donor activities
- personnel from non-participating centers
- refuses to participate
Trial locations and contacts
4 sites in 1 country.
France4 sites
AP-HM Hôpital Nord
Marseille, 13915
Hôpital Guy de Chauliac, CHU de Montpellier
Montpellier, 34295
Hôpital Cimiez, CHU de Nice
Nice, 06003
Centre Hospitalier Universitaire de Nîmes
Nîmes, 30029
About this study
The goal of this study is to evaluate the knowledge of paramedical and medical care personnel concerning organ and tissue donations, as well as their opinions on this activity.
- Conditions
- Tissue and Organ Procurement
- Being tested
- Questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
The subjects are asked to fill out a questionnaire on the personal and professional situations, organ donation legislation, what happens in everyday practice, their own experience with donating their own organs, and what position they take.
| Study group | Role | What they receive |
|---|---|---|
| all 5000 subjects | this is a purely descriptive study with one group Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS Negative/positive feeling
Visual Analog Scale from 0 to 100 where 0 is negative and 100 is positive.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2010 (estimated)
- Study startMar 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tissue and Organ ProcurementStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Prospective
- Enrolment
- 1,859 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline Boutin, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01213069
- Sponsor's protocol ID
- PHRC-I/2009/CB-01
- Other IDs
- 1391089
- Status last verified
- Mar 2015
- First submitted
- 30 Sep 2010
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Staff Opinions and Knowledge Concerning Organ and Tissue Harvesting: an Investigation Among the Patient Care Personnel in the South-Mediterranean Region of France
- ClinicalTrials.gov ID
- NCT01213069
- Acronym / sponsor ID
- PHRC-I/2009/CB-01
- Conditions
- Tissue and Organ Procurement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,859 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 1 Oct 2010 (estimated)
- 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.
The goal of this study is to evaluate the knowledge of paramedical and medical care personnel concerning organ and tissue donations, as well as their opinions on this activity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all 5000 subjects | – | Other: Questionnairesthis is a purely descriptive study with one group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Health care personnel in South-Mediterranean France
Key inclusion criteria (3 listed)
- paramedical or medical care personnel from a participating center
- participates in organ donor activities
- works in a department with organ donor activity
Key exclusion criteria (3 listed)
- personnel with no contact with organ donor activities
- personnel from non-participating centers
- refuses to participate
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 |
|---|---|---|
| QuestionnairesThe subjects are asked to fill out a questionnaire on the personal and professional situations, organ donation legislation, what happens in everyday practice, their own experience with donating their own organs, and what position they take. | Other | all 5000 subjects |
Primary outcome
VAS Negative/positive feeling
Time frame: 1 day
Visual Analog Scale from 0 to 100 where 0 is negative and 100 is positive.
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 Mar 2015.
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Kidney Failure, Chronic, Kidney Transplantation
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.
Caroline Boutin, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tissue and Organ Procurement, run by Centre Hospitalier Universitaire de Nīmes at 4 sites 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 3 inclusion and 3 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 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
VAS Negative/positive feeling (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2015.