Study on CRP Apheresis After Coronary Bypass Surgery (CABY1)

Selective Depletion of C-reactive Protein by Therapeutic Apheresis (CRP Apheresis) After Elective Primary Coronary Bypass Surgery

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.

Study Overview

• Status: Completed
• Conditions: Post-cardiac Surgery
• Intervention / Treatment: Device: CRP apheresis

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 (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 Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Essen, Germany, 45122
    • Klinik für Thorax- und Kardiovaskuläre Chirurgie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• elective, isolated, primary coronary bypass surgery
• 2 or 3-fold CHD with or without main stem stenosis
• Obtained LVEF (> 30%, trans-oesophageal echocardiography (TEE) or angiography)
• Heart-lung machine (HLM; 'two-stage' cannulation)
• Antegrade Bretschneider cardioplegia
• Mild hypothermia (32 °C)
• Standard anesthesia (isoflurane)
• Intraoperative standard protocol (500 mg ASA after 2 h, low dose heparinization after 4 h)
• written informed consent
• legal capacity

Exclusion Criteria:

Preoperatively

• PCI (within last 2 weeks)
• Renal insufficiency (creatinine > 1.3 mmol/L or requiring dialysis)
• Combination interventions
• Re-surgery
• Emergency of urgent surgery indication
• Acute coronary syndrome (IAP, NSTEMI, STEMI)
• Preoperatively positive hs-troponin I > 40 ng/ml
• Chronic arterial fibrillation
• Acute infectious disease (body temperature > 38.0°C)
• Systolic blood pressure < 100 mmHg
• Known hypersensitivity to therapeutic apheresis
• Cardiac shock
• Pregnancy or lactation
• Participation in other interventional trial

During surgery

• Radialis removal
• Coronary TEA (if blood flow within bypass < 20 ml/min)
• Off-pump
• Hemofiltration
• Combination intervention (e.g. mitral valve reconstruction, LAA)
• Maze procedure
• Bypass low-flow closure, ECG changes
• Antithrombotic therapy (intraoperative clopidogrel and/or aspirin)
• Second HLM
• Second cardioplegic cardiac arrest
• Intraaortal balloon pumping / balloon pulsation (IABP)
• Extracorporeal membrane oxygenation (ECMO)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Apheresis Group; 20 patients receive 2 apheresis treatments at intervals of 24 ± 12 h (additionally to the standard therapy after bypass surgery). The first treatment starts within 24 h postoperatively. If the CRP concentration increases to at least 30 mg/L 6-18 h after the end of the second treatment, a third treatment is performed. For each treatment the 1 - 2.5-fold plasma void is processed. The duration of each treatment is 4-6 h.	Device: CRP apheresis; Selective CRP apheresis by use of the PentraSorb-CRP adsorber
No Intervention: Control group; 17 patients of the control group receive the standard therapy after bypass surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tissue damage of the heart	Daily determination of the concentration of the biomarker Troponin I (hsTnI)	Every 24 hours for up to 96 hours after bypass surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of CRP apheresis	Incidence of expected and unexpected adverse effects	24 hours after each apheresis
Cardiac events	Documentation of cardiac events: Cardiac arrythmias; Perioperative myocardial infarction (PMI); Cardiopulmonary resuscitation (CPR); Low cardiac output syndrome (LCOS); Re-surgery; Percutaneous coronary intervention (PCI); Angina pectoris	Until the patient is discharged from the hospital, an average of 7 days
Tissue damage of the heart with Procalcitonin	Daily determination of the concentration of: - Procalcitonin	Every 24 hours for 72 hours after bypass surgery
Tissue damage of the heart with CK-MB	Daily determination of the concentration of: - Creatine kinase, MB fraction (CK-MB)	Every 24 hours for 72 hours after bypass surgery
Tissue damage of the heart with Myoglobin	Daily determination of the concentration of: - Myoglobin	Every 24 hours for 72 hours after bypass surgery
Tissue damage of the heart with Leukocytes	Daily determination of the concentration of: - Leukocytes	Every 24 hours for 72 hours after bypass surgery
Tissue damage of the heart with Interleukin-6	Daily determination of the concentration of: - Interleukin-6 (IL-6)	Every 24 hours for 72 hours after bypass surgery

Collaborators and Investigators

• Sponsor: Pentracor GmbH
• Investigators: Principal Investigator: Matthias Thielmann, Prof. Dr. med., Westdeutsches Herz- und Gefäßzentrum Essen, Klinik für Thorax- und Kardiovaskuläre Chirurgie

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2018
• Primary Completion (Actual): January 28, 2021
• Study Completion (Actual): January 28, 2021

Study Registration Dates

• First Submitted: December 3, 2020
• First Submitted That Met QC Criteria: February 8, 2021
• First Posted (Actual): February 9, 2021

Study Record Updates

• Last Update Posted (Actual): October 18, 2022
• Last Update Submitted That Met QC Criteria: October 17, 2022
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: P02 CABY1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No