Incidence of Acute Cerebrovascular Events Using Either Minimized or Standard Cardiopulmonary Bypass Circuit "ROCsafeTM"

Recruiting

Phase 4 Results N/A

Trial Description

The prospective, randomized, two centre study investigates acute cerebrovascular events during extracorporal circulation and the early post operative outcome when using either the minimized cardiopulmonary bypass circuit (ROCsafeTM) or a standard cardiopulmonary bypass circuit in patients undergoing coronary artery bypass grafting.

Detailed Description

Coronary artery bypass grafting with extracorporal circulation is established as the golden standard. The conventional cardiopulmonary bypass (CPB) system is associated with inflammatory reaction, hemolysis, hemodilution an disturbances of the blood coagulation system. Also it's well known that neurological disturbances caused by embolic material and air bubbles are potential risks of CPB. The new minimized perfusion circuit ROCsafeTM is a closed, reservoir-less, reduced prime, surface coated circuit, with optimized safety features in effectively eliminate both macro and micro air bubbles and should optimize the clinical outcome after CABG using cardiopulmonary bypass.

Conditions

Interventions

  • ROCsafeTM Device
    Intervention Desc: using minimized perfusion circuit while CABG
    ARM 1: Kind: Experimental
    Label: 1
    Description: using minimized cardiopulmonary bypass circuit ROCsafeTM

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary fresh micro-lesions in cranial MRT before and 72 h after CABG Yes
Secondary Death 30 days after CABG Yes
Secondary Neurological events between CABG and discharge Yes
Secondary Neurocognitive function before and 3-4 days after CABG and after 3 months Yes

Sponsors