Study on CRP Apheresis After Coronary Bypass Surgery

Status Completed

Clinical Trial 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.

Clinical Trial 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 (e.g., 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 Design

Related Conditions & MeSH terms

Post-cardiac Surgery

Clinical Trial Details

NCT number	NCT04745468
Study type	Interventional
Source	Pentracor GmbH
Contact
Status	Completed
Phase	N/A
Start date	March 21, 2018
Completion date	January 28, 2021

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Study on CRP Apheresis After Coronary Bypass Surgery — CABY1

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms