An interventional study of Mini extracorporeal circulation and Conventional extracorporeal circulation in Thrombocytopathy, sponsored by Catharina Ziekenhuis Eindhoven. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-01-09.
Sponsored by Catharina Ziekenhuis Eindhoven · Not applicable, Interventional, and Treatment
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:
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 routes inhibited by clopidogrel and acetylsalicylic acid.
MEA calculates three parameters. The most important parameter, the area under the curve (AUC), reflexes the overall platelet activity . The area under the curve is influenced by the total height of the aggregation curve as well as by its slope. The other parameters are the height of the curve that describes the aggregation. The maximum slope of the curve describes the reflex velocity.
Results TEG and MEA contain:
MEA:
51 studies on the registry are indexed under Blood Platelet Disorders; 9 are open to participants now.
This study's enrollment of 40 is below the median of 50 across 27 interventional studies indexed under Blood Platelet Disorders.
Browse Blood Platelet Disorders studies →Catharina Ziekenhuis Eindhoven is the lead sponsor of 85 studies on the registry; 16 are open to participants now.
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Exclusion Criteria:
Patients undergoing coronary artery bypass surgery on minimal extracorporeal circulation
Device: Mini extracorporeal circulation
Patients undergoing coronary artery bypass surgery on conventional extracorporeal circulation
Device: Conventional extracorporeal circulation
Minimal-ECC versus conventional ECC circuits minimise foreign surface-blood interaction and are heparinized from tip to tip. The tubing length has been shortened to decrease crystalloid prime. Cardiotomy suction is minimised, which leads to less fibrinolysis. An active air-removal device is added to the closed circuit. The use of minimal ECC has already shown a significant reduction of the systemic inflammatory reaction and less peroperative transfusion of blood products.
Also known as: Mini- ECC: ECC.O Oxygenator
Also known as: Conventional ECC: D903 Avant Oxygenator
Platelet function
Change in thrombocyte function is measured directly after Protamine and three hours after operation. This change is correlated to the reference preoperatively.
Time frame: Post-cardiopulmonary bypass
Perioperative blood loss
Time frame: 24 hours
Amount of platelet or fresh frozen plasma transfusion
Time frame: 24 hours
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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Catharina Ziekenhuis Eindhoven