ThrombocytopathyECCTEGNCT01935245
Platelet Function in Minimal Extracorporeal Circulation in CABG
A study testing Mini extracorporeal circulation and Conventional extracorporeal circulation in people with Thrombocytopathy, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombocytopathy
- What is being tested?
- Mini extracorporeal circulation and Conventional extracorporeal circulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2013to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective coronary artery bypass grafting
- Use of acetylsalicylic acid
- > 18 years
- body surface area < 2.1 [M2]
Who cannot join
- Emergency procedures
- Platelet function disorders
- Clopidogrel stopped < 5 days
- Thrombocytes < 150/ nanoliter
- Renal insufficiency, creatinin clearance <60 ml/min
- Chronic alcohol abuses
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Catharina hospital Eindhoven
Eindhoven, North Brabant, 5623 EJ
About this study
Official title: 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).
Read more
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
Read the 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)
- Conditions
- Thrombocytopathy
- Being tested
- Mini extracorporeal circulation, Conventional extracorporeal circulation
- Keywords
- Coronary artery bypass grafting, Extracorporeal circulation, Minimal extracorporeal circulation, Coagulopathy, Thrombocytopathy, Platelet dysfunction
- Medical subject headings
- Blood Platelet Disorders, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini extracorporeal circulationDevice
Also called Mini- ECC: ECC.O Oxygenator
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.
Conventional extracorporeal circulationDevice
Also called Conventional ECC: D903 Avant Oxygenator
| Study group | Role | What they receive |
|---|---|---|
| Mini extracorporeal circulation | Experimental | Patients undergoing coronary artery bypass surgery on minimal extracorporeal circulation Receives: Device: Mini extracorporeal circulation |
| Conventional extracorporeal circulation | Active comparator | Patients undergoing coronary artery bypass surgery on conventional extracorporeal circulation Receives: Device: Conventional extracorporeal circulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet function
Change in thrombocyte function is measured directly after Protamine and three hours after operation. This change is correlated to the reference preoperatively.
Measured: Post-cardiopulmonary bypass
Secondary outcomes (1)
Perioperative blood loss
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study startApr 2013
- Primary completionOct 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombocytopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ingeborg Herold, Catharina Ziekenhuis Eindhoven
- Investigators
- Ingeborg HF Herold, MD, Principal investigator, Catharina hospital Eindhoven, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935245
- Sponsor's protocol ID
- NL40546.060.12
- Acronym
- ECCTEG
- Status last verified
- Jan 2015
- First submitted
- 28 Aug 2013
- Last updated
- 9 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Function in Minimal Extracorporeal Circulation Versus Conventional Extracorporeal Circulation in Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT01935245
- Acronym / sponsor ID
- ECCTEG / NL40546.060.12
- Conditions
- Thrombocytopathy
- Keywords
- Coronary artery bypass grafting, Extracorporeal circulation, Minimal extracorporeal circulation, Coagulopathy, Thrombocytopathy, Platelet dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 5 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mini extracorporeal circulation | Experimental | Device: Mini extracorporeal circulationPatients undergoing coronary artery bypass surgery on minimal extracorporeal circulation |
| Conventional extracorporeal circulation | Active comparator | Device: Conventional extracorporeal circulationPatients undergoing coronary artery bypass surgery on conventional extracorporeal circulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Elective coronary artery bypass grafting
- Use of acetylsalicylic acid
- > 18 years
- body surface area < 2.1 [M2]
Key exclusion criteria (6 listed)
- Emergency procedures
- Platelet function disorders
- Clopidogrel stopped < 5 days
- Thrombocytes < 150/ nanoliter
- Renal insufficiency, creatinin clearance <60 ml/min
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mini extracorporeal circulationAlso: Mini- ECC: ECC.O OxygenatorMinimal-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. | Device | Mini extracorporeal circulation |
| Conventional extracorporeal circulationAlso: Conventional ECC: D903 Avant Oxygenator | Device | Conventional extracorporeal circulation |
Primary outcome
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.
1 secondary outcome
Perioperative blood loss
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ingeborg HF Herold, MD principal investigator
Catharina hospital Eindhoven, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mini extracorporeal circulation and Conventional extracorporeal circulation in people with Thrombocytopathy, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet function (time frame: Post-cardiopulmonary bypass). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2015.