Platelet Function in Minimal Extracorporeal Circulation in CABG (ECCTEG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01935245
Recruitment Status : Completed
First Posted : September 5, 2013
Last Update Posted : January 9, 2015
Information provided by (Responsible Party):
Ingeborg Herold, Catharina Ziekenhuis Eindhoven

Brief Summary:


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).


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.


Group 1: CABG using minimal ECC Group 2: CABG using conventional ECC

Main study parameters/endpoints:

  1. Results of TEG and MEA, see detailed description
  2. Per operative blood loss and total blood loss 24 hours after CABG
  3. Total amount of transfused platelet units during CABG and 24 hours after CABG

Condition or disease Intervention/treatment Phase
Thrombocytopathy Device: Mini extracorporeal circulation Device: Conventional extracorporeal circulation Not Applicable

Detailed Description:

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:

  • TEG angle
  • TEG K
  • TEG LY 30
  • TEG MA
  • TEG R


  • MEA adenosine diphosphate (ADP)
  • MEA arachidonic acid
  • MEA collagen
  • MEA thrombin receptor activating peptide (TRAP)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Platelet Function in Minimal Extracorporeal Circulation Versus Conventional Extracorporeal Circulation in Coronary Artery Bypass Grafting
Study Start Date : April 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Mini extracorporeal circulation
Patients undergoing coronary artery bypass surgery on minimal extracorporeal circulation
Device: Mini 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.

Other Name: Mini- ECC: ECC.O Oxygenator
Active Comparator: Conventional extracorporeal circulation
Patients undergoing coronary artery bypass surgery on conventional extracorporeal circulation
Device: Conventional extracorporeal circulation
Other Name: Conventional ECC: D903 Avant Oxygenator

Primary Outcome Measures :
  1. Platelet function [ Time Frame: Post-cardiopulmonary bypass ]
    Change in thrombocyte function is measured directly after Protamine and three hours after operation. This change is correlated to the reference preoperatively.

Secondary Outcome Measures :
  1. Perioperative blood loss [ Time Frame: 24 hours ]

Other Outcome Measures:
  1. Amount of platelet or fresh frozen plasma transfusion [ Time Frame: 24 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Elective coronary artery bypass grafting
  • Use of acetylsalicylic acid
  • > 18 years
  • body surface area < 2.1 [M2]

Exclusion Criteria:

  • Emergency procedures
  • Platelet function disorders
  • Clopidogrel stopped < 5 days
  • Thrombocytes < 150/ nanoliter
  • Renal insufficiency, creatinin clearance <60 ml/min
  • Chronic alcohol abuses

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01935245

Catharina hospital Eindhoven
Eindhoven, Brabant, Netherlands, 5623 EJ
Sponsors and Collaborators
Catharina Ziekenhuis Eindhoven
Principal Investigator: Ingeborg HF Herold, MD Catharina hospital Eindhoven, The Netherlands

Responsible Party: Ingeborg Herold, MD, Catharina Ziekenhuis Eindhoven Identifier: NCT01935245     History of Changes
Other Study ID Numbers: NL40546.060.12
First Posted: September 5, 2013    Key Record Dates
Last Update Posted: January 9, 2015
Last Verified: January 2015

Keywords provided by Ingeborg Herold, Catharina Ziekenhuis Eindhoven:
Coronary artery bypass grafting
Extracorporeal circulation
Minimal extracorporeal circulation
Platelet dysfunction

Additional relevant MeSH terms:
Blood Platelet Disorders
Hematologic Diseases