NCT04588350

Clinical Investigation Evaluating a New Autotransfusion Device in Cardiac Surgery

Prospective, Multicenter, Single-arm Clinical Investigation Evaluating the Safety, Performance and Clinical Benefit of a New Autotransfusion Device in Cardiac Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: i-SEP · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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). 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).

Conditions

• Hemorrhage
• Blood Loss
• Surgical Blood Loss

Interventions

Type	Name	Description
DEVICE	i-SEP autotransfusion system	Intraoperative recovery and washing of the processed blood by i-SEP autotransfusion system in surgeries where a bleeding is expected

Timeline

• Start date: 2020-09-28
• Primary completion: 2021-05-14
• Completion: 2021-09-20
• First posted: 2020-10-19
• Last updated: 2021-11-15

Locations

5 sites across 1 country: France