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Platelet Function in Minimal Extracorporeal Circulation in CABG (ECCTEG)

Primary Purpose

Thrombocytopathy

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Mini extracorporeal circulation
Conventional extracorporeal circulation
Sponsored by
Catharina Ziekenhuis Eindhoven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thrombocytopathy focused on measuring Coronary artery bypass grafting, Extracorporeal circulation, Minimal extracorporeal circulation, Coagulopathy, Thrombocytopathy, Platelet dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Catharina hospital Eindhoven

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mini extracorporeal circulation

Conventional extracorporeal circulation

Arm Description

Patients undergoing coronary artery bypass surgery on minimal extracorporeal circulation

Patients undergoing coronary artery bypass surgery on conventional extracorporeal circulation

Outcomes

Primary Outcome Measures

Platelet function
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

Perioperative blood loss

Full Information

First Posted
August 28, 2013
Last Updated
January 8, 2015
Sponsor
Catharina Ziekenhuis Eindhoven
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1. Study Identification

Unique Protocol Identification Number
NCT01935245
Brief Title
Platelet Function in Minimal Extracorporeal Circulation in CABG
Acronym
ECCTEG
Official Title
Platelet Function in Minimal Extracorporeal Circulation Versus Conventional Extracorporeal Circulation in Coronary Artery Bypass Grafting
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catharina Ziekenhuis Eindhoven

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombocytopathy
Keywords
Coronary artery bypass grafting, Extracorporeal circulation, Minimal extracorporeal circulation, Coagulopathy, Thrombocytopathy, Platelet dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mini extracorporeal circulation
Arm Type
Experimental
Arm Description
Patients undergoing coronary artery bypass surgery on minimal extracorporeal circulation
Arm Title
Conventional extracorporeal circulation
Arm Type
Active Comparator
Arm Description
Patients undergoing coronary artery bypass surgery on conventional extracorporeal circulation
Intervention Type
Device
Intervention Name(s)
Mini extracorporeal circulation
Other Intervention Name(s)
Mini- ECC: ECC.O Oxygenator
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Conventional extracorporeal circulation
Other Intervention Name(s)
Conventional ECC: D903 Avant Oxygenator
Primary Outcome Measure Information:
Title
Platelet function
Description
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
Secondary Outcome Measure Information:
Title
Perioperative blood loss
Time Frame
24 hours
Other Pre-specified Outcome Measures:
Title
Amount of platelet or fresh frozen plasma transfusion
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingeborg HF Herold, MD
Organizational Affiliation
Catharina hospital Eindhoven, The Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
Catharina hospital Eindhoven
City
Eindhoven
State/Province
Brabant
ZIP/Postal Code
5623 EJ
Country
Netherlands

12. IPD Sharing Statement

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Platelet Function in Minimal Extracorporeal Circulation in CABG

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