Trial document




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  DRKS00013012

Trial Description

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Title

Selective depletion of the C-reactive protein by means of therapeutic CRP apheresis to reduce myocardial damage after coronary bypass surgery

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Trial Acronym

CABY1

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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.

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Organizational Data

  •   DRKS00013012
  •   2017/09/15
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  •   no
  •   Approved
  •   17-7484-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

  •   U1111-1201-8155 
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Health Condition or Problem studied

  •   I25 -  Chronic ischaemic heart disease
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Interventions/Observational Groups

  •   20 patients receive 2 apheresis treatments at intervals of 24 ± 12 hrs (additionally to the standard therapy after bypass surgery). The first treatment starts within 24 hours 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 hours.
  •   20 patients of the control group receive the standard therapy after bypass surgery.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Tissue damage of the heart.
Determination (daily) by the biomarker Troponin I (hsTnI) up to 96 h after the bypass surgery.

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Secondary Outcome

Safety of CRP apheresis:
In order to assess the safety, a continuous monitoring of the vital parameters of blood pressure, heart rate and oxygen saturation as well as the general condition of the participants during the treatments are carried out.

Cardiac events up to hospital discharge:
- Cardiac arrhythmias
- Perioperative myocardial infarction (PMI)
- Cardiopulmonary resuscitation (CPR)
- Low cardiac output syndrome (LCOS)
- Re-operation
- Percutaneous coronary intervention (PCI)
- Angina pectoris

Tissue damage of the heart until 72 h after bypass surgery:
- Creatine kinase, MB fraction (CK-MB)
- Heart-type Fatty Acid Binding Protein (hFABP)
- Procalcitonin
- Myoglobin
- Leukocytes
- Interleukin-6 (IL-6)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/03/21
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   79   Years
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Additional Inclusion Criteria

• elective, isolated, primary coronary bypass surgery
• 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 (complete heparinization with ACT > 400 s, tranexamic acid, protamine)
• Postoperative standard protocol (500 mg ASA after 2 h, low dose heparinization after 4 h)
• written informed consent
• legal capacity

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Exclusion Criteria

Preoperatively
• Age <18 ≥ 80 years
• PCI (within the last 2 weeks)
• Renal insufficiency (creatinine > 1.3 mmol / L)
• Combination interventions
• Reoperation
• Emergency or urgent surgery indication
• Acute coronary syndrome (IAP, NSTEMI, STEMI)
• Preoperatively positive hs-troponin I > 40 ng / ml
• Chronic atrial fibrillation
• Acute infectious disease (body temperature (auricular, sublingual) > 38.0 °C)
• Systolic blood pressure < 100 mmHg
• Known hypersensitivity to therapeutic aphereses
• Cardiac shock
• Renal insufficiency requiring dialysis (see above)
• Pregnancy or lactation
• Participation in other interventional trial

During surgery:
• Radialis removal
• Coronary TEA (thrombendarteriectomy)
• Off-pump
• Hemofiltration
• Combination intervention (e.g., mitral valve reconstruction (MKR), LAA (Left Auriculus Atrii))
• 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)

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Addresses

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    • Pentracor GmbH
    • Neuendorfstr. 23 b/d
    • 16761  Hennigsdorf
    • Germany
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    • Pentracor GmbH
    • Mr.  Dr.  Burghard  Thiesen 
    • Neuendorfstr. 23 b/d
    • 16761  Hennigsdorf
    • Germany
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    • Klinik für Thorax- und Kardiovaskuläre ChirurgieWestdeutsches Herz- und Gefäßzentrum Essen
    • Mr.  Prof. Dr. med.  Matthias  Thielmann 
    • Hufelandstraße 55
    • 45122  Essen
    • Germany
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Sources of Monetary or Material Support

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    • Pentracor GmbH
    • Neuendorfstr. 23 b/d
    • 16761  Hennigsdorf
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.