Ignite Creation Date:
2024-05-06 @ 3:17 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04588350
Status:
COMPLETED
Last Update Posted:
2021-11-15
First Post:
2020-09-28
Brief Title:
Clinical Investigation Evaluating a New Autotransfusion Device in Cardiac Surgery
Sponsor:
i-SEP
Organization:
i-SEP
Study Overview
Official Title:
Prospective Multicenter Single-arm Clinical Investigation Evaluating the Safety Performance and Clinical Benefit of a New Autotransfusion Device in Cardiac Surgery
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
i-TRANSEP
Brief Summary:
Blood transfusion is at the heart of the therapeutic arsenal when there is a hemorrhage andor 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 patients 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 andor 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
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 andor 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 ones own blood by the patients 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 patients 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 urologyThe 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 andor 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
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 patients 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 urologyThe 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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None