ThrombopeniaPLATCATNCT02906878
Platelet Kinetics After Platelet Transfusion for the Placement of a Central Venous Catheter
An observational study of Thrombopenia and Central Venous Catheter Placement, run by University Hospital, Angers at 1 site in France.
Trial summary
PLATCAT study's purpose is to evaluate platelet kinetics after platelet transfusion Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombopenia, Central Venous Catheter Placement
- What is being tested?
- Platelets transfusion
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2016to Jul 2017
- 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: Haematology patients who needs a central venous catheter and with a non-auto immune thrombopenia
Who may be able to join
- Admission en haematology unit
- Need for a central venous catheter
- Thrombopenia < 50 G/L
Who cannot join
- Patient protected by law
- Pregnant or breastfeeding women
- Peripheral thrombopenia
- Patient admitted in Intensive Care Unit
Trial locations and contacts
1 site in 1 country.
Aline SCHMIDT, MD contact
About this study
Official title: Evaluation of the Effectiveness and Security of the Prophylactic Platelet Transfusion in Thrombocytopenic Patients Requiring the Placement of a Central Venous Catheter
PLATCAT study's purpose is to evaluate platelet kinetics after platelet transfusion
- Conditions
- Thrombopenia, Central Venous Catheter Placement
- Being tested
- Platelets transfusion
- Keywords
- Intensive Care, Haematology, Platelets prophylactic transfusion
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelets transfusionProcedure or surgery
Prophylactic platelet transfusion in thrombocytopenic patients for the placement of a central venous catheter
What is being measured
The primary outcome is the main question the study is designed to answer.
72 hours thrombocythemia kinetics after a platelet transfusion
Blood drawing a H-1:00, H+0:10, H+1:00, H+4:00, H+24h00, H+72:00 Evaluation of platelets count on sodium citrate tube.
Measured: 72 hours post transfusion
Secondary outcomes (3)
Transfusion Safety - assessed by Troubles during process
Troubles during process (pneumothorax, laying failure, hematoma) Hematoma at H+24:00 Immunisation anti HLA,HPA
Measured: One day after transfusion
Transfusion Efficacy
Number of blood or platelets transfusion
Measured: One month after transfusion
Description of patients treatment
Type of received chemotherapy
Measured: One week before and one month after transfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startJun 2016
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombopeniaStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nicolas LEROLLE, MD PhD, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02906878
- Sponsor's protocol ID
- 2015-AO1924-45
- Acronym
- PLATCAT
- Status last verified
- Sep 2016
- First submitted
- 5 Jul 2016
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness and Security of the Prophylactic Platelet Transfusion in Thrombocytopenic Patients Requiring the Placement of a Central Venous Catheter
- ClinicalTrials.gov ID
- NCT02906878
- Acronym / sponsor ID
- PLATCAT / 2015-AO1924-45
- Conditions
- Thrombopenia, Central Venous Catheter Placement
- Keywords
- Intensive Care, Haematology, Platelets prophylactic transfusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Jun 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 20 Sep 2016 (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.
PLATCAT study's purpose is to evaluate platelet kinetics after platelet transfusion
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Haematology patients who needs a central venous catheter and with a non-auto immune thrombopenia
Key inclusion criteria (3 listed)
- Admission en haematology unit
- Need for a central venous catheter
- Thrombopenia < 50 G/L
Key exclusion criteria (4 listed)
- Patient protected by law
- Pregnant or breastfeeding women
- Peripheral thrombopenia
- Patient admitted in Intensive Care Unit
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 |
|---|---|---|
| Platelets transfusionProphylactic platelet transfusion in thrombocytopenic patients for the placement of a central venous catheter | Procedure or surgery | – |
Primary outcome
72 hours thrombocythemia kinetics after a platelet transfusion
Time frame: 72 hours post transfusion
Blood drawing a H-1:00, H+0:10, H+1:00, H+4:00, H+24h00, H+72:00 Evaluation of platelets count on sodium citrate tube.
3 secondary outcomes
Transfusion Safety - assessed by Troubles during process
Time frame: One day after transfusion
Transfusion Efficacy
Time frame: One month after transfusion
Description of patients treatment
Time frame: One week before and one month after transfusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2016.
- Individual participant dataSharing planned: No
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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.
Aline SCHMIDT, MD contact
Nicolas LEROLLE, MD PhD principal investigator
University Hospital, Angers
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 Thrombopenia and Central Venous Catheter Placement, run by University Hospital, Angers 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 3 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: status not confirmed, as of the sponsor's last update on 20 Sep 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicolas LEROLLE, MD PhD (+33241353478, NiLerolle@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
72 hours thrombocythemia kinetics after a platelet transfusion (time frame: 72 hours post transfusion). 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 20 Sep 2016.