Hemorrhagei-TRANSEPNCT04588350
Clinical Investigation Evaluating a New Autotransfusion Device in Cardiac Surgery
A study testing i-SEP autotransfusion system in people with Hemorrhage and Blood Loss, run by i-SEP at 5 sites in France.
Trial summary
Blood transfusion is at the heart of the therapeutic arsenal when there is a hemorrhage and/or blood loss during a surgery. There are two types of transfusion: the homologous one (blood from a compatible donor) and the autologous or autotransfusion method (which is done with the patient's own blood). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhage, Blood Loss, Surgical Blood Loss
- What is being tested?
- i-SEP autotransfusion system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesFrance
- Study dates
- 28 Sep 2020to 20 Sep 2021
- Phase
- Interventional
- 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
Who may be able to join
- Preoperative Inclusion Criteria:
- Is the patient able and willing to give informed consent before participating in the study?
- Is the patient aged ≥ 18 years?
- Does the patient have a social protection system?
- Does the patient weigh ≥ 59kg (for the sole purpose of blood assessment related to the clinical study)?
- Is the patient indicated for a cardiac surgery with the implementation of a Cardio Pulmonary Bypass (CPB)?
Show all 10Show fewer
- Does the patient have a preoperative hemoglobin ≥ 13g / L for a man and ≥ 12g / L for a woman?
- Does the patient have a preoperative platelets count ≥ 150000 / μL?
- Intraoperative Inclusion Criteria:
- Does the patient have anticoagulated blood losses ≥ 500mL (without considering priming volume in the first cycle)?
Who cannot join
- Preoperative Exclusion Criteria:
- Is the patient indicated for a surgery because of a suspected or confirmed cancer?
- Does the patient have any systemic or local infection in the area of intervention, suspected or proven?
- Does the patient have any pathology of hemostasis (Hemophilia, ...) or bleeding disorder confirmed, or strongly suspected on the examination of the patient in consultation (high score on the formalized questionnaire: HEMSTOP)?
- Is the patient's life expectancy of less than 2 months?
- Does the patient have any psychiatric condition that could, in the opinion of the investigator, prevent him / her from participating in this study?
Show all 23Show fewer
- Does the patient have any objections to transfusion (homologous)?
- Is the patient participating in or has participated in another clinical study in the last 30 days at the day of screening and has received (or is receiving) treatments that could have an impact on the effectiveness of the autotransfusion?
- Does the investigator consider that the patient (or the surgical conditions) is not appropriate to be included in this clinical study?
- Does the patient have a TIH - Heparin-Induced Thrombocytopenia - suspected or confirmed and therefore cannot receive heparin?
- Is the patient pregnant or a lactating woman?
- Is the patient a woman of childbearing age who is not on effective contraceptive treatment?
- Is the patient due to have combined surgeries?
- Has the patient been admitted for an emergency surgery?
- Does the patient have an endocarditis?
- Has the patient been admitted for a redux surgery?
- Has the patient been admitted for a heart transplantation or a mechanical circulatory support surgery?
- Has the patient been admitted for congenital heart surgery?
- Has the patient taken
- any anti-platelet aggregation drugs (except acid acetylsalicylic - aspirin) including Ticagrelor, Clopidogrel and Prasugrel or,
- any anticoagulant drugs (intake of vitamin K antagonists or DOAC = direct oral anti-coagulant including rivaroxaban, Edoxaban, Apixaban and Dabigatran), outside the recommendations from EACTS / EACTA and GHIP?
- Intraoperative Exclusion Criteria:
- Is the "emergency" mode available on the i-Sep machine used during surgery?
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU de Bordeaux - GH Pellegrin
Bordeaux
CHU de Nantes
Nantes
Ap-Hp - Hegp
Paris
CHU de Bordeaux - GH Sud
Pessac
CHU de Rennes
Rennes
About this study
Official title: Prospective, Multicenter, Single-arm Clinical Investigation Evaluating the Safety, Performance and Clinical Benefit of a New Autotransfusion Device in Cardiac Surgery
Blood transfusion is at the heart of the therapeutic arsenal when there is a hemorrhage and/or blood loss during a surgery. There are two types of transfusion: the homologous one (blood from a compatible donor) and the autologous or autotransfusion method (which is done with the patient's own blood).
Although homologous transfusions can save lives, it can cause significant adverse events. Since then, multiple solutions have been developed to avoid exposing patients to these risks. It is in this context that was born the "Patient Blood Management" (PBM). Thus, the strategy in this PBM has been defined as "the appropriate use of blood and blood components, with the aim of minimizing the use of allogeneic transfusions".
Read more
In this context, particular interest has been given to autologous transfusion or autotransfusion or cell salvage, the general purpose is to reduce (or even stop) the use of allogeneic products and to reduce the risks associated with the ABO compatibility system, as well as all the adverse effects associated with allogeneic plasma and platelet transfusions.
Most autotransfusers available on the market operate by centrifugation. Autotransfusion is already a solution in Patient Blood Management and its efficiency and safety have already been optimized. However, there is still a need to improve the quality of the treated blood with an easier-to-use device that could improve the quality of the blood concentrate.
Indeed, with the current devices, it may happen that the use of allogeneic transfusions, plasma and platelets transfusions, is necessary in addition to autologous red blood cells thus reducing the interest of autotransfusion.
It is in this context that i-SEP has developed a new autotransfusion device based on a filtration method. Unlike competing devices, the i-SEP device allows the concentration of not only red blood cells (as competitive devices) but also platelets.
In this study, the i-SEP device is used in typical clinical applications of autotransfusion: cardiovascular and orthopedic surgeries, where there is a risk of hemorrhage and/or blood loss for example ≥ 500mL in cardiac surgery and ≥ 300mL in orthopedic surgery.
The study includes a screening phase (≤ 21Days), surgery phase when the i-SEP device is used (Day 0), a post-surgery phase (Day 1 - Day 6), a first follow-up visit (Day 7 ± 3) and a second follow-up visit (Day 30 ± 7).
Read the detailed description
Blood transfusion is at the heart of the therapeutic arsenal when one wishes to preserve the hemodynamic balance of a patient. There are two types of transfusion: the homologous one (blood from a compatible donor) and the autologous or autotransfusion method (which is done with one's own blood / by the patient's own blood).
Although homologous transfusions can save lives, it may lead to non-negligible adverse events. Among these events, immunological consequences such as allo-immunization against red blood cells' antigens from the donor blood can be cited. Some infections have also been reported following allogenic transfusions.
Since then, multiple solutions have been developed to avoid exposing patients to these risks. It is in this context that was born the "Patient Blood Management" (PBM). Thus, the strategy in this PBM has been defined as "the appropriate use of blood and blood components, with the aim of minimizing the use of allogeneic transfusions". In this context, particular interest has been given to autologous transfusion or autotransfusion or cell salvage.
The principle of Intra-Operative Cell Salvaged (IOCS) allows intravenous administration of the patient's own blood collected at the surgical site or postoperative wound during hemorrhagic surgery. It is used mainly in cardiac, vascular, transplant and elective orthopedic surgeries and tends to spread to other surgeries such as neurosurgery, obstetrics and urology.The IOCS has multiple benefits, primarily autologous (the patient gets his own blood), immediate availability in the operating room, reduced costs of patient care, and the recycling of otherwise lost blood products. It is part of blood saving techniques that avoid the use of homologous blood. Indeed, the general purpose of IOCS is to reduce (or even stop) the use of allogeneic products and to reduce the risks associated with the ABO compatibility system, as well as all the adverse effects associated with allogeneic plasma and platelet transfusions
Most autotransfusers available on the market operate by centrifugation. Autotransfusion is already a solution in Patient Blood Management and its efficiency and safety have already been optimized. However, there is still a need to improve the quality of the treated blood with an easier-to-use device that could improve the quality of the blood concentrate.
Indeed, with the current devices, it may happen that the use of allogeneic transfusions, plasma and platelets transfusions, is necessary in addition to autologous red blood cells thus reducing the interest of autotransfusion.
It is in this context that i-SEP has developed a new autotransfusion device based on a filtration method. Unlike competing devices, the i-SEP device allows the concentration of not only red blood cells (as competitive devices) but also platelets.
In this study, the i-SEP device is used in typical clinical applications of autotransfusion: cardiovascular and orthopedic surgeries, where there is a risk of hemorrhage and/or blood loss for example ≥ 500mL in cardiac surgery and ≥ 300mL in orthopedic surgery.
The study includes a screening phase (≤ 21Days), surgery phase when the i-SEP device is used (Day 0), a post-surgery phase (Day 1 - Day 6), a first follow-up visit (Day 7 ± 3) and a second follow-up visit (Day 30 ± 7).
- Conditions
- Hemorrhage, Blood Loss, Surgical Blood Loss
- Being tested
- i-SEP autotransfusion system
- Keywords
- Autotransfusion, Cell salvage, Patient blood management
- Medical subject headings
- Hemorrhage, Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i-SEP autotransfusion systemDevice
Also called same TM, MT0003, i-SEP ATS
Intraoperative recovery and washing of the processed blood by i-SEP autotransfusion system in surgeries where a bleeding is expected
| Study group | Role | What they receive |
|---|---|---|
| i-SEP autotransfusion system | Experimental | Use of i-SEP autotransfusion system during the surgery Receives: Device: i-SEP autotransfusion system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the device in terms of elimination of contaminants such as heparin and hemolysis markers (free hemoglobin)
Proportion of patients with heparin washout ≥ 90% and with free hemoglobin washout ≥ 75% on the concentrated blood from the i-SEP device
Measured: Day 0
Performance of the device in terms of exceeding red blood cell recovery and hematocrit / hemoglobin thresholds
Proportion of patients with mean Red Blood Cells (RBCs) recovery ≥ 80% and with mean output Hematocrit ≥ 40% or hemoglobin concentration ≥ 13.3g/dL. Mean recovery is calculated with quantification in the pre-treatment blood (after pre-filtration through the blood collection reservoir) and quantification in the concentrated blood, mean output is calculated on the concentrated blood.
Measured: Day 0
Secondary outcomes (15)
Incidence of adverse events
Proportion of patients with adverse events (especially Serious Adverse Events, Serious Adverse Device Effects)
Measured: Up to 1 month follow-up
Incidence of homologous transfusion
Proportion of patients with homologous transfusion (number of units and type of blood product infused) during operative and post-operative period
Measured: Up to 1 month follow-up
Incidence of re-intervention for bleeding
Proportion of patients with re-intervention for bleeding during post-operative period
Measured: Up to 1 month follow-up
Contaminants concentration such as heparin and hemolysis markers (free hemoglobin) in the concentrated blood
Concentration of heparin and free hemoglobin in the treated (concentrated) blood from the i-SEP device
Measured: Day 0
Evolution of the patient's complete blood count
Evolution of the patient complete blood count after surgery as compared to before surgery
Measured: Up to Day 2
Blood loss in drainage after surgery
Quantity and evolution of the patient blood loss in drainage after surgery
Measured: Up to Day 2 and/or to drainage removal
White Blood Cells yield
Quantification of White Blood Cells in the pre-treatment blood (after pre-filtration through the blood collection reservoir) and in the concentrated blood from the i-SEP device
Measured: Day 0
Hematocrit yield
Quantification of hematocrit in the pre-treatment blood (after pre-filtration through the blood collection reservoir) and in the concentrated blood from the i-SEP device
Measured: Day 0
Hemoglobin yield
Quantification of hemoglobin in the pre-treatment blood (after pre-filtration through the blood collection reservoir) and in the concentrated blood from the i-SEP device
Measured: Day 0
Total protein yield
Quantification of total protein in the pre-treatment blood (after pre-filtration through the blood collection reservoir) and in the concentrated blood from the i-SEP device
Measured: Day 0
Albumin yield
Quantification of albumin in the pre-treatment blood (after pre-filtration through the blood collection reservoir) and in the concentrated blood from the i-SEP device
Measured: Day 0
Potassium yield
Quantification of potassium in the pre-treatment blood (after pre-filtration through the blood collection reservoir) and in the concentrated blood from the i-SEP device
Measured: Day 0
Fat yield through triglyceride assay
Quantification of fat through triglyceride measurements in the pre-treatment blood (after pre-filtration through the blood collection reservoir) and in the concentrated blood from the i-SEP device
Measured: Day 0
Performance of the device in terms of platelets recovery
Platelet yield and their functionality through platelet activation and degranulation measured in the pre-treatment blood (after pre-filtration through the blood collection reservoir) and in the concentrated blood from the i-SEP device
Measured: Day 0
High levels of red blood cell recovery and hematocrit / hemoglobin thresholds
Proportion of patients with mean output Hematocrit ≥ 45% or hemoglobin concentration ≥ 15.5g/dL in the concentrated blood from the i-SEP device
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start28 Sep 2020
- Primary completion14 May 2021
- Study completion20 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemorrhageStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm study in cardiac surgery
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- i-SEP
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francis Gadrat, MD, Study chair, i-SEPNicolas Nesseler, MD, Principal investigator, CHU de Rennes, Rennes, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04588350
- Sponsor's protocol ID
- ETC2017-002
- Acronym
- i-TRANSEP
- Status last verified
- Nov 2021
- First submitted
- 28 Sep 2020
- Last updated
- 15 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mansour A, Beurton A, Godier A, Rozec B, Zlotnik D, Nedelec F, Gaussem P, Fiore M, Boissier E, Nesseler N, Ouattara A. Combined Platelet and Red Blood Cell Recovery during On-pump Cardiac Surgery Using same by i-SEP Autotransfusion Device: A First-in-human Noncomparative Study (i-TRANSEP Study). Anesthesiology. 2023 Sep 1;139(3):287-297. doi: 10.1097/ALN.0000000000004642.
PubMed 37294939
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Single-arm Clinical Investigation Evaluating the Safety, Performance and Clinical Benefit of a New Autotransfusion Device in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04588350
- Acronym / sponsor ID
- i-TRANSEP / ETC2017-002
- Conditions
- Hemorrhage, Blood Loss, Surgical Blood Loss
- Keywords
- Autotransfusion, Cell salvage, Patient blood management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- i-SEPIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 14 May 2021 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 19 Oct 2020 (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.
Blood transfusion is at the heart of the therapeutic arsenal when there is a hemorrhage and/or blood loss during a surgery. There are two types of transfusion: the homologous one (blood from a compatible donor) and the autologous or autotransfusion method (which is done with the patient's own blood).
Although homologous transfusions can save lives, it can cause significant adverse events. Since then, multiple solutions have been developed to avoid exposing patients to these risks. It is in this context that was born the "Patient Blood Management" (PBM). Thus, the strategy in this PBM has been defined as "the appropriate use of blood and blood components, with the aim of minimizing the use of allogeneic transfusions".
In this context, particular interest has been given to autologous transfusion or autotransfusion or cell salvage, the general purpose is to reduce (or even stop) the use of allogeneic products and to reduce the risks associated with the ABO compatibility system, as well as all the adverse effects associated with allogeneic plasma and platelet transfusions.
Most autotransfusers available on the market operate by centrifugation. Autotransfusion is already a solution in Patient Blood Management and its efficiency and safety have already been optimized. However, there is still a need to improve the quality of the treated blood with an easier-to-use device that could improve the quality of the blood concentrate.
Indeed, with the current devices, it may happen that the use of allogeneic transfusions, plasma and platelets transfusions, is necessary in addition to autologous red blood cells thus reducing the interest of autotransfusion.
It is in this context that i-SEP has developed a new autotransfusion device based on a filtration method. Unlike competing devices, the i-SEP device allows the concentration of not only red blood cells (as competitive devices) but also platelets.
In this study, the i-SEP device is used in typical clinical applications of autotransfusion: cardiovascular and orthopedic surgeries, where there is a risk of hemorrhage and/or blood loss for example ≥ 500mL in cardiac surgery and ≥ 300mL in orthopedic surgery.
The study includes a screening phase (≤ 21Days), surgery phase when the i-SEP device is used (Day 0), a post-surgery phase (Day 1 - Day 6), a first follow-up visit (Day 7 ± 3) and a second follow-up visit (Day 30 ± 7).
Detailed description
Blood transfusion is at the heart of the therapeutic arsenal when one wishes to preserve the hemodynamic balance of a patient. There are two types of transfusion: the homologous one (blood from a compatible donor) and the autologous or autotransfusion method (which is done with one's own blood / by the patient's own blood).
Although homologous transfusions can save lives, it may lead to non-negligible adverse events. Among these events, immunological consequences such as allo-immunization against red blood cells' antigens from the donor blood can be cited. Some infections have also been reported following allogenic transfusions.
Since then, multiple solutions have been developed to avoid exposing patients to these risks. It is in this context that was born the "Patient Blood Management" (PBM). Thus, the strategy in this PBM has been defined as "the appropriate use of blood and blood components, with the aim of minimizing the use of allogeneic transfusions". In this context, particular interest has been given to autologous transfusion or autotransfusion or cell salvage.
The principle of Intra-Operative Cell Salvaged (IOCS) allows intravenous administration of the patient's own blood collected at the surgical site or postoperative wound during hemorrhagic surgery. It is used mainly in cardiac, vascular, transplant and elective orthopedic surgeries and tends to spread to other surgeries such as neurosurgery, obstetrics and urology.The IOCS has multiple benefits, primarily autologous (the patient gets his own blood), immediate availability in the operating room, reduced costs of patient care, and the recycling of otherwise lost blood products. It is part of blood saving techniques that avoid the use of homologous blood. Indeed, the general purpose of IOCS is to reduce (or even stop) the use of allogeneic products and to reduce the risks associated with the ABO compatibility system, as well as all the adverse effects associated with allogeneic plasma and platelet transfusions
Most autotransfusers available on the market operate by centrifugation. Autotransfusion is already a solution in Patient Blood Management and its efficiency and safety have already been optimized. However, there is still a need to improve the quality of the treated blood with an easier-to-use device that could improve the quality of the blood concentrate.
Indeed, with the current devices, it may happen that the use of allogeneic transfusions, plasma and platelets transfusions, is necessary in addition to autologous red blood cells thus reducing the interest of autotransfusion.
It is in this context that i-SEP has developed a new autotransfusion device based on a filtration method. Unlike competing devices, the i-SEP device allows the concentration of not only red blood cells (as competitive devices) but also platelets.
In this study, the i-SEP device is used in typical clinical applications of autotransfusion: cardiovascular and orthopedic surgeries, where there is a risk of hemorrhage and/or blood loss for example ≥ 500mL in cardiac surgery and ≥ 300mL in orthopedic surgery.
The study includes a screening phase (≤ 21Days), surgery phase when the i-SEP device is used (Day 0), a post-surgery phase (Day 1 - Day 6), a first follow-up visit (Day 7 ± 3) and a second follow-up visit (Day 30 ± 7).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm study in cardiac surgery
| Arm | Type | Receives |
|---|---|---|
| i-SEP autotransfusion system | Experimental | Device: i-SEP autotransfusion systemUse of i-SEP autotransfusion system during the surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Is the patient able and willing to give informed consent before participating in the study?
- Is the patient aged ≥ 18 years?
- Does the patient have a social protection system?
- Does the patient weigh ≥ 59kg (for the sole purpose of blood assessment related to the clinical study)?
- Is the patient indicated for a cardiac surgery with the implementation of a Cardio Pulmonary Bypass (CPB)?
Key exclusion criteria (23 listed)
- Is the patient indicated for a surgery because of a suspected or confirmed cancer?
- Does the patient have any systemic or local infection in the area of intervention, suspected or proven?
- Does the patient have any pathology of hemostasis (Hemophilia, ...) or bleeding disorder confirmed, or strongly suspected on the examination of the patient in consultation (high score on the formalized questionnaire: HEMSTOP)?
- Is the patient's life expectancy of less than 2 months?
- Does the patient have any psychiatric condition that could, in the opinion of the investigator, prevent him / her from participating in this 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 |
|---|---|---|
| i-SEP autotransfusion systemAlso: same TM, MT0003, i-SEP ATSIntraoperative recovery and washing of the processed blood by i-SEP autotransfusion system in surgeries where a bleeding is expected | Device | i-SEP autotransfusion system |
Primary outcome
Safety of the device in terms of elimination of contaminants such as heparin and hemolysis markers (free hemoglobin)
Time frame: Day 0
Proportion of patients with heparin washout ≥ 90% and with free hemoglobin washout ≥ 75% on the concentrated blood from the i-SEP device
Performance of the device in terms of exceeding red blood cell recovery and hematocrit / hemoglobin thresholds
Time frame: Day 0
Proportion of patients with mean Red Blood Cells (RBCs) recovery ≥ 80% and with mean output Hematocrit ≥ 40% or hemoglobin concentration ≥ 13.3g/dL. Mean recovery is calculated with quantification in the pre-treatment blood (after pre-filtration through the blood collection reservoir) and quantification in the concentrated blood, mean output is calculated on the concentrated blood.
15 secondary outcomes
Incidence of adverse events
Time frame: Up to 1 month follow-up
Incidence of homologous transfusion
Time frame: Up to 1 month follow-up
Incidence of re-intervention for bleeding
Time frame: Up to 1 month follow-up
Contaminants concentration such as heparin and hemolysis markers (free hemoglobin) in the concentrated blood
Time frame: Day 0
Evolution of the patient's complete blood count
Time frame: Up to Day 2
Blood loss in drainage after surgery
Time frame: Up to Day 2 and/or to drainage removal
White Blood Cells yield
Time frame: Day 0
Hematocrit yield
Time frame: Day 0
Hemoglobin yield
Time frame: Day 0
Total protein yield
Time frame: Day 0
Albumin yield
Time frame: Day 0
Potassium yield
Time frame: Day 0
Fat yield through triglyceride assay
Time frame: Day 0
Performance of the device in terms of platelets recovery
Time frame: Day 0
High levels of red blood cell recovery and hematocrit / hemoglobin thresholds
Time frame: Day 0
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 15 Nov 2021.
- Derived from this study: PubMed 37294939Mansour A, Beurton A, Godier A, Rozec B, Zlotnik D, Nedelec F, Gaussem P, Fiore M, Boissier E, Nesseler N, Ouattara A. Combined Platelet and Red Blood Cell Recovery during On-pump Cardiac Surgery Using same by i-SEP Autotransfusion Device: A First-in-human Noncomparative Study (i-TRANSEP Study). Anesthesiology. 2023 Sep 1;139(3):287-297. doi: 10.1097/ALN.0000000000004642.
- 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.
Francis Gadrat, MD study chair
i-SEP
Nicolas Nesseler, MD principal investigator
CHU de Rennes, Rennes, France
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing i-SEP autotransfusion system in people with Hemorrhage and Blood Loss, run by i-SEP at 5 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 10 inclusion and 23 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 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Safety of the device in terms of elimination of contaminants such as heparin and hemolysis markers (free hemoglobin) (time frame: Day 0). The study lists 2 primary outcomes in all. 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 NCT04588350, which also lists 1 linked publication.
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 15 Nov 2021.