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Clinical Trials/NCT01935245
NCT01935245
Completed
Not Applicable

Platelet Function in Minimal Extracorporeal Circulation Versus Conventional Extracorporeal Circulation in Coronary Artery Bypass Grafting

Catharina Ziekenhuis Eindhoven1 site in 1 country40 target enrollmentApril 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Thrombocytopathy
Sponsor
Catharina Ziekenhuis Eindhoven
Enrollment
40
Locations
1
Primary Endpoint
Platelet function
Status
Completed
Last Updated
11 years ago

Overview

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:

  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

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

Registry
clinicaltrials.gov
Start Date
April 2013
End Date
December 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Catharina Ziekenhuis Eindhoven
Responsible Party
Principal Investigator
Principal Investigator

Ingeborg Herold

MD

Catharina Ziekenhuis Eindhoven

Eligibility Criteria

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

Outcomes

Primary Outcomes

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 Outcomes

  • Perioperative blood loss(24 hours)

Study Sites (1)

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