Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04745468
Status:
COMPLETED
Last Update Posted:
2022-10-18
First Post:
2020-12-03
Brief Title:
Study on CRP Apheresis After Coronary Bypass Surgery
Sponsor:
Pentracor GmbH
Organization:
Pentracor GmbH
Study Overview
Official Title:
Selective Depletion of C-reactive Protein by Therapeutic Apheresis CRP Apheresis After Elective Primary Coronary Bypass Surgery
Status:
COMPLETED
Status Verified Date:
2021-02
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:
CABY1
Brief Summary:
The CABY1 study is conducted open controlled randomized and monocentric The efficacy and tolerability of CRP apheresis in patients undergoing elective primary coronary bypass surgery is investigated
Detailed Description:
CABY1 is a clinical trial to study the reduction of C-reactive protein CRP by therapeutic apheresis CRP apheresis in patients undergoing elective primary coronary bypass surgery
The term therapeutic apheresis describes therapeutical procedures whose effect is based on the elimination of blood components with a pathogenic function within the disease process Elimination takes place in adsorbers outside the body in an extracorporeal circuit To remove the pathogenic substances blood plasma is separated from the circuit and passed through an adsorber The purified blood plasma is then reunited with the solid blood components and returned to the patient
The PentraSorb CRP adsorber used for CRP apheresis is CE-certified It serves for the selective depletion of the C-reactive protein from human plasma
As a cause of the damaging effect of the C-reactive protein it is assumed that the CRP as an inflammatory mediator favours the destruction of cardiac muscle tissue in conjunction with complement and has a negative influence on the regeneration of the traumatized tissue
The aim of the CABY1 study is to investigate if the tissue damage of the heart can be reduced by depletion of the C-reactive protein after elective coronary bypass surgery A possible protective effect of CRP apheresis will be determined from laboratory biomarkers eg troponin I CM-MB IL-6 and cardiac events
20 randomly selected patients receive apheresis treatments with a duration of 4-6 h each the following 2-3 days after bypass surgery the 20 patients of the controls do not receive apheresis The biomarkers required for the evaluation of the treatment success are determined over a period of 4 days after surgery on the basis of the routine blood tests Cardiac events are documented until the patient is discharged
The term therapeutic apheresis describes therapeutical procedures whose effect is based on the elimination of blood components with a pathogenic function within the disease process Elimination takes place in adsorbers outside the body in an extracorporeal circuit To remove the pathogenic substances blood plasma is separated from the circuit and passed through an adsorber The purified blood plasma is then reunited with the solid blood components and returned to the patient
The PentraSorb CRP adsorber used for CRP apheresis is CE-certified It serves for the selective depletion of the C-reactive protein from human plasma
As a cause of the damaging effect of the C-reactive protein it is assumed that the CRP as an inflammatory mediator favours the destruction of cardiac muscle tissue in conjunction with complement and has a negative influence on the regeneration of the traumatized tissue
The aim of the CABY1 study is to investigate if the tissue damage of the heart can be reduced by depletion of the C-reactive protein after elective coronary bypass surgery A possible protective effect of CRP apheresis will be determined from laboratory biomarkers eg troponin I CM-MB IL-6 and cardiac events
20 randomly selected patients receive apheresis treatments with a duration of 4-6 h each the following 2-3 days after bypass surgery the 20 patients of the controls do not receive apheresis The biomarkers required for the evaluation of the treatment success are determined over a period of 4 days after surgery on the basis of the routine blood tests Cardiac events are documented until the patient is discharged
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