German company conducts a study on CRP Apheresis After Coronary Bypass Surgery
The company Pentracor GmbH is conducting the clinical trial Study on CRP Apheresis After Coronary Bypass Surgery (CABY1).
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 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.
One primary outcome measure is Tissue damage of the heart. Daily determination of the concentration of the biomarker Troponin I (hsTnI).
Among the inclusion criteria are:
- 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)
The location of the study is as follows (further details can be found here https://ichgcp.net/clinical-trials-registry/NCT04745468) Essen, Germany.
