PlateletsPLAQ-SESNCT06629311
Platelet and Autotransfusion Device in Cardiac Surgery
An observational study of Platelets and Autotransfusion Device, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Cardiac surgery is a bleeding-risk surgery and frequently requires blood transfusion. Intraoperative autotransfusion devices are used to aspirate, process and retransfuse patients' blood. These devices are effective in recovering red blood cells and limiting the need for transfusion of packed red blood cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Platelets, Autotransfusion Device
- What is being tested?
- Autotransfusion device
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 4 Feb 2025to 8 Sep 2026
- How long will I take part?
- 32 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients addressed in a university hospital for cardiac surgery
Who may be able to join
- Patients over 18 years of age
- Having undergone standard cardiac surgery (excluding redux surgery, dissection, endocarditis, circulatory assist and transplants)
- Treated with an autotransfusion device during the surgery
- Subject having expressed their consent to the study
Who cannot join
- Anemia less than 7 g/dL
- Pregnant women
- Redux surgery, dissection, endocarditis, circulatory assistance, and transplants
- Contraindication to the use of an autotransfusion device
- Impossibility of giving the subject informed information
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg, Bas-Rhin, 67091
About this study
Official title: Study of Platelet Count Changes During the Use of Autotransfusion Device in Cardiac Surgery
Cardiac surgery is a bleeding-risk surgery and frequently requires blood transfusion. Intraoperative autotransfusion devices are used to aspirate, process and retransfuse patients' blood. These devices are effective in recovering red blood cells and limiting the need for transfusion of packed red blood cells. Some devices, such as I-SEP's SAME®, can also be used to recover platelets, but their effectiveness has not yet been evaluated in real-life situations. The aim of this study is therefore to investigate the evolution of platelet counts following the use of an intraoperative recovery device in adult patients undergoing standard cardiac surgery
- Conditions
- Platelets, Autotransfusion Device
- Being tested
- Autotransfusion device
- Keywords
- Cardiac surgery, Autotransfusion device, Platelets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autotransfusion deviceDevice
Standard cardiac surgery using I-SEP and SAME™ autotransfusion device
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet count
Study the evolution of platelet counts following the use of I-SEP's SAME™ autotransfusion device in major patients undergoing standard cardiac surgery
Measured: Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device
Secondary outcomes (7)
To study the evolution of platelet count following the use of the autotransfusion device (other than SAME) in major patients undergoing standard cardiac surgery.
Measured: Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device
To study the evolution of platelet function (flow cytometry and flow aggregation) following the use of a autotransfusion device in major patients undergoing standard cardiac surgery.
Measured: Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device
Study the evolution of platelet function according to the autotransfusion device used.
Measured: Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device
Study post-operative bleeding volume as a function of autotransfusion device type.
Measured: Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device
Study the volume of labile blood product transfusion according to the autotransfusion device used.
Measured: Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device
Study the intensity of post-operative inflammatory syndrome as a function of the autotransfusion device used.
Measured: Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device
Study platelet adhesion to the autotransfusion device membranes using electron microscopy.
Measured: Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start4 Feb 2025
- Primary completion8 Sep 2026 (estimated)
- Study completion8 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PlateletsStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- 100 participants (estimated)
- Target duration
- 32 Days
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629311
- Sponsor's protocol ID
- 9264
- Acronym
- PLAQ-SES
- Status last verified
- Mar 2025
- First submitted
- 3 Oct 2024
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Platelet Count Changes During the Use of Autotransfusion Device in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06629311
- Acronym / sponsor ID
- PLAQ-SES / 9264
- Conditions
- Platelets, Autotransfusion Device
- Keywords
- Cardiac surgery, Autotransfusion device, Platelets
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 4 Feb 2025 (actual)
- Primary completion
- 8 Sep 2026 (estimated)
- Study completion
- 8 Sep 2026 (estimated)
- First posted
- 8 Oct 2024 (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.
Cardiac surgery is a bleeding-risk surgery and frequently requires blood transfusion. Intraoperative autotransfusion devices are used to aspirate, process and retransfuse patients' blood. These devices are effective in recovering red blood cells and limiting the need for transfusion of packed red blood cells. Some devices, such as I-SEP's SAME®, can also be used to recover platelets, but their effectiveness has not yet been evaluated in real-life situations. The aim of this study is therefore to investigate the evolution of platelet counts following the use of an intraoperative recovery device in adult patients undergoing standard cardiac surgery
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 32 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients addressed in a university hospital for cardiac surgery
Key inclusion criteria (4 listed)
- Patients over 18 years of age
- Having undergone standard cardiac surgery (excluding redux surgery, dissection, endocarditis, circulatory assist and transplants)
- Treated with an autotransfusion device during the surgery
- Subject having expressed their consent to the study
Key exclusion criteria (5 listed)
- Anemia less than 7 g/dL
- Pregnant women
- Redux surgery, dissection, endocarditis, circulatory assistance, and transplants
- Contraindication to the use of an autotransfusion device
- Impossibility of giving the subject informed information
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 |
|---|---|---|
| Autotransfusion deviceStandard cardiac surgery using I-SEP and SAME™ autotransfusion device | Device | – |
Primary outcome
Platelet count
Time frame: Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device
Study the evolution of platelet counts following the use of I-SEP's SAME™ autotransfusion device in major patients undergoing standard cardiac surgery
7 secondary outcomes
To study the evolution of platelet count following the use of the autotransfusion device (other than SAME) in major patients undergoing standard cardiac surgery.
Time frame: Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device
To study the evolution of platelet function (flow cytometry and flow aggregation) following the use of a autotransfusion device in major patients undergoing standard cardiac surgery.
Time frame: Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device
Study the evolution of platelet function according to the autotransfusion device used.
Time frame: Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device
Study post-operative bleeding volume as a function of autotransfusion device type.
Time frame: Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device
Study the volume of labile blood product transfusion according to the autotransfusion device used.
Time frame: Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device
Study the intensity of post-operative inflammatory syndrome as a function of the autotransfusion device used.
Time frame: Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device
Study platelet adhesion to the autotransfusion device membranes using electron microscopy.
Time frame: Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- 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.
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 Platelets and Autotransfusion Device, run by University Hospital, Strasbourg, France 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 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: looking for participants now, as of the sponsor's last update on 3 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charles TACQUARD, PHU (+33 6 69 55 16 08, charlesambroise.tacquard@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet count (time frame: Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device). 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 3 Apr 2025.