Cardiac Surgery Under Extra Corporeal CirculationSAME-CELLNCT06766032
Comparison of the Performance and Effectiveness of Two Transfusion-Saving Devices: Cell-Saver and SAME
An observational study of Cardiac Surgery Under Extra Corporeal Circulation and Cardiac Surgery Requiring Cardiopulmonary Bypass, run by Nantes University Hospital at 1 site in France.
Trial summary
An observational study comparing two systems of perioperative blood recovery in cardiac surgery, one system allowing red blood cell reinfusion and one system allowing red blood cell and platelet reinfusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery Under Extra Corporeal Circulation, Cardiac Surgery Requiring Cardiopulmonary Bypass
- What is being tested?
- CELL-Saver and SAME
- Type of treatment
- Medical device
- How many people
- 304 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jun 2021to 28 Jul 2024
- 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: Adult patients treated by the cardiac surgery department of Nantes University Hospital who undergo a cardiovascular procedure with cardiopulmonary bypass considered to be at high risk for bleeding; (prolonged cardiopulmonary bypass >2 hours, aortic arch surgery, history of redo cardiac surgery, combined surgery, multiple portocoronary bypasses). Procedures for which a perioperative blood recovery device (SAME or Cell-Saver) has been used, with the choice of the blood recovery technique at the discretion of the medical team.
Who may be able to join
- Scheduled cardiac surgery under cardiopulmonary bypass with a predicted duration of more than 2 hours, or surgery of the aortic arch, redo surgery, multiple aorto-coronary bypasses (>2), or combined surgery (valvular and coronary).
Who cannot join
- Pre-existing constitutional or acquired bleeding disorder (hemophilia A or B, von Willebrand disease, myelodysplastic/myeloproliferative syndrome)
- Patients with sepsis, a malignant tumor at the surgical site, or contamination of recovered blood with biological fluids/antiseptics/distilled water/local antibiotics/hemostatic agents.
- Organ transplantation and planned circulatory support in the preoperative period
- Uni-bi-ventricular artificial heart
- Reoperation in a patient already included in the study
- Patient refusing blood transfusion
- Pregnant women
- Legally Protected adults
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Performance and Effectiveness of Two Transfusion-Saving Devices: Cell-Saver for Red Blood Cell Reinfusion and SAME for Red Blood Cell and Platelet Reinfusion
An observational study comparing two systems of perioperative blood recovery in cardiac surgery, one system allowing red blood cell reinfusion and one system allowing red blood cell and platelet reinfusion. The objective is to evaluate whether platelet recovery provides better quality of hemostasis during and after surgery, improving transfusion savings, and whether it reduces postoperative complications and the length of stay in the intensive care unit and in the hospital.
Read the detailed description
° Primary outcome of the study : The primary outcome of the study is to compare the evolution of perioperative platelet count based on the type of blood recovery used, either SAME or Cell-Saver.
The main outcome measure is the difference between the preoperative and immediate postoperative platelet counts (delta platelet) for each patient between the SAME and Cell-Saver groups.
° Secondary outcomes of the study:
The secondary outcomes are to evaluate, from the preoperative period until day 28 postoperatively:
- The post-operative platelet count between days 1 and 5
- The frequency of perioperative and postoperative transfusions, including the number and type of blood products transfused
- The use of derivative medications (fibrinogen, prothrombin complex concentrates)
- The volume of postoperative bleeding
- The frequency of postoperative events (infectious, renal, thromboembolic, hemorrhagic)
- The length of stay in the intensive care unit and in the hospital
- The frequency of treatment for postoperative anemia with iron or erythropoiesis-stimulating agents.
- Conditions
- Cardiac Surgery Under Extra Corporeal Circulation, Cardiac Surgery Requiring Cardiopulmonary Bypass
- Being tested
- CELL-Saver, SAME
- Keywords
- cell-saver, auto-transfusion, platelet transfusion, blood saving techniques
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CELL-SaverDevice
The Cell-saver device allows for red blood cell reinfusion during cardiac surgery.
SAMEDevice
The SAME device allows for red blood cell and platelet reinfusion during cardiac surgery.
| Study group | Role | What they receive |
|---|---|---|
| Cell-Saver group | Patients for whom the Cell-saver device is used during cardiac surgery. Receives: Device: CELL-Saver | |
| SAME group | Patients for whom the SAME device is used during cardiac surgery. Receives: Device: SAME |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between the preoperative and immediate postoperative platelet counts (delta of platelet) for each patient
The main outcome measure is the difference between the preoperative and immediate postoperative platelet counts (delta platelet) for each patient in the Cell-saver group or in the SAME group.
Measured: up to 1 week
Secondary outcomes (7)
Postoperative platelet
Postoperative platelet count between day 1 and day 5
Measured: 5 days
Perioperative and postoperative transfusions
Frequency of perioperative and postoperative transfusions, number and type of blood products transfused from surgery (day 1) to 28 days after surgery
Measured: 28 days
Derivative medications
Use of derivative medications (fibrinogen, prothrombin complex concentrates) from surgery (day 1) to 28 days after surgery
Measured: 28 days
Postoperative bleeding
Volume of postoperative bleeding from surgery (day 1) to 28 days after surgery
Measured: 28 days
Postoperative events
Frequency of postoperative events (infectious, renal, thromboembolic, hemorrhagic) from surgery (day 1) to 28 days after surgery
Measured: 28 days
Durations of stays
Duration of stays in the intensive care unit and in the hospital from surgery (day 1) to 28 days after surgery
Measured: 28 days
Postoperative anemia
Frequency of treatment for postoperative anemia with iron or erythropoiesis-stimulating agents from surgery (day 1) to 28 days after surgery
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start5 Jun 2021
- Primary completion1 Jul 2024
- Study completion28 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgery Under Extra Corporeal CirculationStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mickaël Vourc'h, MD-PhD, Principal investigator, Nantes HU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766032
- Sponsor's protocol ID
- AR_2024_001
- Acronym
- SAME-CELL
- Status last verified
- Jan 2025
- First submitted
- 16 Dec 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Performance and Effectiveness of Two Transfusion-Saving Devices: Cell-Saver for Red Blood Cell Reinfusion and SAME for Red Blood Cell and Platelet Reinfusion
- ClinicalTrials.gov ID
- NCT06766032
- Acronym / sponsor ID
- SAME-CELL / AR_2024_001
- Conditions
- Cardiac Surgery Under Extra Corporeal Circulation, Cardiac Surgery Requiring Cardiopulmonary Bypass
- Keywords
- cell-saver, auto-transfusion, platelet transfusion, blood saving techniques
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 5 Jun 2021 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 28 Jul 2024 (actual)
- First posted
- 9 Jan 2025 (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.
An observational study comparing two systems of perioperative blood recovery in cardiac surgery, one system allowing red blood cell reinfusion and one system allowing red blood cell and platelet reinfusion. The objective is to evaluate whether platelet recovery provides better quality of hemostasis during and after surgery, improving transfusion savings, and whether it reduces postoperative complications and the length of stay in the intensive care unit and in the hospital.
Detailed description
° Primary outcome of the study : The primary outcome of the study is to compare the evolution of perioperative platelet count based on the type of blood recovery used, either SAME or Cell-Saver.
The main outcome measure is the difference between the preoperative and immediate postoperative platelet counts (delta platelet) for each patient between the SAME and Cell-Saver groups.
° Secondary outcomes of the study:
The secondary outcomes are to evaluate, from the preoperative period until day 28 postoperatively:
- The post-operative platelet count between days 1 and 5
- The frequency of perioperative and postoperative transfusions, including the number and type of blood products transfused
- The use of derivative medications (fibrinogen, prothrombin complex concentrates)
- The volume of postoperative bleeding
- The frequency of postoperative events (infectious, renal, thromboembolic, hemorrhagic)
- The length of stay in the intensive care unit and in the hospital
- The frequency of treatment for postoperative anemia with iron or erythropoiesis-stimulating agents.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cell-Saver group | – | Device: CELL-SaverPatients for whom the Cell-saver device is used during cardiac surgery. |
| SAME group | – | Device: SAMEPatients for whom the SAME device is used during cardiac surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients treated by the cardiac surgery department of Nantes University Hospital who undergo a cardiovascular procedure with cardiopulmonary bypass considered to be at high risk for bleeding; (prolonged cardiopulmonary bypass >2 hours, aortic arch surgery, history of redo cardiac surgery, combined surgery, multiple portocoronary bypasses). Procedures for which a perioperative blood recovery device (SAME or Cell-Saver) has been used, with the choice of the blood recovery technique at the discretion of the medical team.
Key inclusion criteria (1 listed)
- Scheduled cardiac surgery under cardiopulmonary bypass with a predicted duration of more than 2 hours, or surgery of the aortic arch, redo surgery, multiple aorto-coronary bypasses (>2), or combined surgery (valvular and coronary).
Key exclusion criteria (8 listed)
- Pre-existing constitutional or acquired bleeding disorder (hemophilia A or B, von Willebrand disease, myelodysplastic/myeloproliferative syndrome)
- Patients with sepsis, a malignant tumor at the surgical site, or contamination of recovered blood with biological fluids/antiseptics/distilled water/local antibiotics/hemostatic agents.
- Organ transplantation and planned circulatory support in the preoperative period
- Uni-bi-ventricular artificial heart
- Reoperation in a patient already included in the study
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 |
|---|---|---|
| CELL-SaverThe Cell-saver device allows for red blood cell reinfusion during cardiac surgery. | Device | Cell-Saver group |
| SAMEThe SAME device allows for red blood cell and platelet reinfusion during cardiac surgery. | Device | SAME group |
Primary outcome
Difference between the preoperative and immediate postoperative platelet counts (delta of platelet) for each patient
Time frame: up to 1 week
The main outcome measure is the difference between the preoperative and immediate postoperative platelet counts (delta platelet) for each patient in the Cell-saver group or in the SAME group.
7 secondary outcomes
Postoperative platelet
Time frame: 5 days
Perioperative and postoperative transfusions
Time frame: 28 days
Derivative medications
Time frame: 28 days
Postoperative bleeding
Time frame: 28 days
Postoperative events
Time frame: 28 days
Durations of stays
Time frame: 28 days
Postoperative anemia
Time frame: 28 days
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 9 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
Mickaël Vourc'h, MD-PhD principal investigator
Nantes HU
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 Cardiac Surgery Under Extra Corporeal Circulation and Cardiac Surgery Requiring Cardiopulmonary Bypass, run by Nantes University Hospital 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 1 inclusion and 8 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 9 Jan 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?
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?
Difference between the preoperative and immediate postoperative platelet counts (delta of platelet) for each patient (time frame: up to 1 week). 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 9 Jan 2025.