- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01935245
Platelet Function in Minimal Extracorporeal Circulation in CABG (ECCTEG)
Platelet Function in Minimal Extracorporeal Circulation Versus Conventional Extracorporeal Circulation in Coronary Artery Bypass Grafting
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
Study Overview
Status
Conditions
Intervention / Treatment
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)
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Brabant
-
Eindhoven, Brabant, Netherlands, 5623 EJ
- Catharina Hospital Eindhoven
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mini extracorporeal circulation
Patients undergoing coronary artery bypass surgery on minimal 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 Names:
|
Active Comparator: Conventional extracorporeal circulation
Patients undergoing coronary artery bypass surgery on conventional extracorporeal circulation
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Post-cardiopulmonary bypass
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Perioperative blood loss
Time Frame: 24 hours
|
24 hours
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Amount of platelet or fresh frozen plasma transfusion
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ingeborg HF Herold, MD, Catharina Hospital Eindhoven, The Netherlands
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL40546.060.12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Thrombocytopathy
-
Region StockholmKarolinska InstitutetRecruitingPlatelet Disorder | Thrombocytopathy | Platelet Function DisorderSweden
-
Assiut UniversityUnknownBleeding | Platelet DysfunctionEgypt
-
Kratochvil Milan, MDIBA - Masaryk University Institute of biostatistics and analysesUnknownHip Replacement, Total | Hemorrhage, Surgical | Thrombocytopathy
-
McMaster UniversitySt. Joseph's Healthcare HamiltonWithdrawnCardiovascular Diseases | End-stage Renal Disease | ThrombocytopathyCanada
-
Institute of Biophysics and Cell Engineering of...Belarusian Research Center for Pediatric Oncology, Hematology and ImmunologyNot yet recruitingHemorrhagic Disorders | Immune Thrombocytopenia | Acute Leukemia | Thrombocytopathy
-
Rabin Medical CenterGenzyme, a Sanofi CompanyUnknown
Clinical Trials on Mini extracorporeal circulation
-
Fundació Institut de Recerca de l'Hospital de la...CompletedCoronary Artery DiseaseSpain
-
University Hospital Inselspital, BerneCompletedAortic Valve Stenosis | Extracorporeal CirculationSwitzerland
-
Europainclinics z.ú.East Slovak Institute for Cardiovascular DiseasesRecruiting
-
University of PadovaCompletedCognitive Dysfunction | Emergence Delirium | HypothermiaItaly
-
Sahlgrenska University Hospital, SwedenCompletedRenal Impairment | Complication of Extracorporeal CirculationSweden
-
Örebro County CouncilCompleted
-
Research Institute for Complex Problems of Cardiovascular...CompletedSepsis | Systemic Inflammatory Response Syndrome | Multiorgan Failure
-
Peking Union Medical College HospitalUnknownSepsis | Cardiopulmonary BypassChina
-
University Hospital Center of MartiniqueCentre Hospitalier Universitaire Dijon; University Hospital, Limoges; Assistance... and other collaboratorsCompletedPatients Requiring Cardiac SurgeryFrance
-
Kuopio University HospitalUniversity of Eastern FinlandCompletedAtrial FibrillationFinland