Clinical Trial: Platelet Function in Minimal Extracorporeal Circulation in CABG
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Platelet Function in Minimal Extracorporeal Circulation Versus Conventional Extracorporeal Circulation in Coronary Artery Bypass Grafting
Brief Summary:
Rationale:
Cardiac surgery with extracorporeal circulation (ECC) triggers platelets. Minimal extracorporeal circulation system (minimal-ECC) has several advantages compared with conventional ECC amongst less platelet activation. Platelet function can be analysed with thromboelastography (TEG) and multiple electrode aggregometry (MEA).
Objective:
The use of minimal ECC leads to less platelet dysfunction compared with conventional ECC in coronary artery bypass grafting (CABG) analysed with TEG and MEA
Study design:
Single center, prospective, randomized, pilot study
Study population:
Group 1:
20 patients undergoing CABG using minimal ECC. Patients continued the use of acetylsalicylic acid and discontinued the use of clopidogrel minimal 5 days preoperative.
Group 2:
20 patients undergoing CABG using conventional ECC. Patients continued the use of acetylsalicylic acid and discontinued the use of clopidogrel minimal 5 days preoperative.
Intervention:
Group 1: CABG using minimal ECC Group 2: CABG using conventional ECC
Main study parameters/endpoints:
- Results of TEG and MEA, see detailed description
- Per operative blood loss and total blood loss 24 hours after CABG
Detailed Summary:
Platelet function test
Thromboelastography (TEG) TEG is a test which provides information on the complete haemostasis. Also fibrinolysis can be measured. The strength of the clot can be measured. This provides information about platelet concentration, -function and platelet-fibrin interaction. It is measured in a medium with added heparinase, an enzyme that degrades heparin,, which makes TEG measurement possible during ECC. The results from the TEG will be displayed graphically and numerically. The letter R (reaction time) represents the time before the clot formation starts. This time is predominately dependent on coagulation factors and inhibitors such as heparin. The velocity at which the clot is then formed is displayed as the letter K (time between 2 mm en 20 mm amplitude in the thromboelastogram). The firmness of the clot is the maximum amplitude in the thromboelastogram (MA) and is dependent on the amount and function of the thrombocytes, fibrinogen concentration and factor XIII concentration of the sample. Fibrinolysis will be visualised in the parameter that displays the velocity of dissolving the clot (LY30= fibrinolysis 30 minutes after MA).
In case of a severe coagulation factor independency or use of heparin, the R parameter will be elongated. In severe thrombocytopathy, thrombocytopenia or a low fibrinogen concentration the graphic will show a lowered MA. In hyperfibrinolysis the LY30 will be elongated.
Multiple electrode Aggregometry (MEA) MEA is a technique to test platelet function in whole blood based on classical impedance aggregometry. The use of whole blood makes centrifugation redundant. The use of agonist ADP, arachidonic acid, collagen and TRAP provides information about platelet aggregation, and simultaneously provides specific information of the ro
Sponsor: Catharina Ziekenhuis Eindhoven
Current Primary Outcome: Platelet function [ Time Frame: Post-cardiopulmonary bypass ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Perioperative blood loss [ Time Frame: 24 hours ]
Original Secondary Outcome: Same as current
Information By: Catharina Ziekenhuis Eindhoven
Dates:
Date Received: August 28, 2013
Date Started: April 2013
Date Completion:
Last Updated: January 8, 2015
Last Verified: January 2015
