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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00007580 |
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Date of registration:
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03/12/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The influence of the surgical technique and the method of coagulation monitoring on changes in the coagulation system during coronary artery bypass grafting operations
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Scientific title:
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The influence of the surgical technique and the method of coagulation monitoring on changes in the coagulation system during coronary artery bypass grafting operations - HEPCON |
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Date of first enrolment:
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25/01/2013 |
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Target sample size:
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120 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00007580 |
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Study type:
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interventional |
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Study design:
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Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: parallel; Study design purpose: treatment
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Phase:
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N/A
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Countries of recruitment
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Germany
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Contacts
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Name:
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Hagen
Gorki |
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Address:
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Albert-Einstein-Allee 23
89081
Ulm
Germany |
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Telephone:
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0049 731 500 54400 |
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Email:
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hagen.gorki@uniklinik-ulm.de |
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Affiliation:
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Univeristät UlmKlinik für Herz-, Thorax- undGefäßchirurgie |
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Name:
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Hagen
Gorki |
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Address:
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Albert-Einstein-Allee 23
89081
Ulm
Germany |
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Telephone:
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0049 731 500 54405 |
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Email:
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hagen.gorki@uniklinik-ulm.de |
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Affiliation:
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Univeristät UlmKlinik für Herz-, Thorax- undGefäßchirurgie |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. isolated coronary artery disease, equally treatable with all three surgical techniques of the study
2. at least three graftable target coronary arteries
Exclusion criteria: 1. Emergency operation (unstable condition, inotropic support, operation < 12 hours after diagnosis)
2. Inborn or aquired bleeding/coagulation disorder (except antiplatelet medication)
3. Liver disease (reduced synthesis of clotting factors) or gatrointestinal disease with risk of bleeding
4. Left ventricular function < 35%
5. Age < 18 years, > 85 years
6. Preoperatively known specific anatomical conditions preventing a randomisation of surgical technique (e.g. porcelain aorta)
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic ischaemic heart disease, unspecified
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I25.9
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I25.9
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Intervention(s)
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Group 1: 40 patients are operated on with a classical heart-lung-machine (HLM) and scheduled for at least three distal anastomoses to the coronary arteries. Furthermore, patients are randomized for anticoagulation management. Anticoagulation by heparin is monitored in 20 patients by activated clotting time (ACT) and in 20 patients by an intermittend measurement of heparin conentration according to an individual initial dose response curve.
Group 2: 40 patients are operated on with a minimized heart-lung-machine (minimized extracorporeal circulation, MECC) and scheduled for at least three distal anastomoses to the coronary arteries. Furthermore, patients are randomized for anticoagulation management. Anticoagulation by heparin is monitored in 20 patients by activated clotting time (ACT) and in 20 patients by an intermittend measurement of heparin conentration according to an individual initial dose response curve.
Group 3: 40 patients are operated on without the help of a heart-lung-machine (OPCAB) and scheduled for at least three distal anastomoses to the coronary arteries. Furthermore, patients are randomized for anticoagulation management. Anticoagulation by heparin is monitored in 20 patients by activated clotting time (ACT) and in 20 patients by an intermittend measurement of heparin conentration according to an individual initial dose response curve.
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Primary Outcome(s)
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total heparin and protamine dose during operation
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Secondary Outcome(s)
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clinical relevant parameters (postoperative drainage blood loss, usage of blood/blood products), markers of coagulation system (PTT, INR, platelets, coagulation factors I, II, V, VIII, X, ATIII, TAT, TFPI, PTF1.2, d-dimer), of the renal system (crea, urea, eGFR, KIM I, NGAL, alphaGST, L-FABP), and of the inflammation system (CRP, leuco, TNFalpha, Pselectin, ICAM1) are measured and compared.
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Source(s) of Monetary Support
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Medtronic GmbH
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Universitätsklinik UlmKlinik für Herz-, Thorax- und Gefäßchirurgie
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Maquet
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Ethics review
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Status: Approved
Approval date: 15/11/2012
Contact:
ethik-kommission@uni-ulm.de
Ethikkommission der Universität Ulm
+49-731-50022050
ethik-kommission@uni-ulm.de
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