Trial document





This trial has been registered retrospectively.
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  DRKS00007580

Trial Description

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Title

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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Trial Acronym

HEPCON

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URL of the Trial

[---]*

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Brief Summary in Lay Language

120 patients scheduled for a coronary bypass operation are operated on by one of three available surgical techniques (1. on classical heart-lung-machine, 2. on minimized heart-lung-machine, 3. without heart-lung-machine "off-pump" beating heart) and the mandatory anticoagulation is managed by one of two available methods (1. activated clotting time, 2. individualized measurement of the anticoagulant agent heparin). Blood and urine samples are taken at 7 time points (before and up to 72 hours after operation) and changes of the blood coagulation system, kidney function and inflammation are investigated and compared between the different treatment options. This study is designed to test two hypotheses: 1. forgoing a classical heart-lung machine reduces inflammation and minimizes strain on the patients' coagulation system and kidneys, and 2. individualized anticoagulation management reduces blood losses and transfusions.

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Brief Summary in Scientific Language

120 patients with multivessel coronary artery disease and at least three graftable targets are randomized by surgical technique (conventional CPB. MECC, OPCAB) and test method of anticoagulation status during surgery (ACT, heparin concentration). Blood and urine specimen are taken preoperatively and up to 72 hours postoperatively. Changes of 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. This study is designed to test two hypotheses: 1. forgoing a classical heart-lung machine reduces inflammation and minimizes strain on the patients' coagulation system and kidneys, and 2. individualized anticoagulation management reduces blood losses and transfusions.

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Organizational Data

  •   DRKS00007580
  •   2014/12/03
  •   [---]*
  •   no
  •   Approved
  •   264/12, Ethik-Kommission der Universität Ulm
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   I25.9 -  Chronic ischaemic heart disease, unspecified
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Interventions/Observational Groups

  •   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.
  •   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.
  •   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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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

total heparin and protamine dose during operation

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Secondary Outcome

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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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/01/25
  •   120
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   85   Years
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Additional 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

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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)

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Addresses

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    • Univeristät UlmKlinik für Herz-, Thorax- undGefäßchirurgie
    • Mr.  Dr. med.  Hagen  Gorki 
    • Albert-Einstein-Allee 23
    • 89081  Ulm
    • Germany
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    • Univeristät UlmKlinik für Herz-, Thorax- undGefäßchirurgie
    • Mr.  Dr. med.  Hagen  Gorki 
    • Albert-Einstein-Allee 23
    • 89081  Ulm
    • Germany
    end of 1:1-Block address scientific-contact
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    • Univeristät UlmKlinik für Herz-, Thorax- undGefäßchirurgie
    • Mr.  Dr. med.  Hagen  Gorki 
    • Albert-Einstein-Allee 23
    • 89081  Ulm
    • Germany
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Sources of Monetary or Material Support

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    • Medtronic GmbH
    • Earl-Bakken-Platz 1
    • 40670  Meerbusch
    • Germany
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    •   [---]*
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    • Universitätsklinik UlmKlinik für Herz-, Thorax- und Gefäßchirurgie
    • Albert-Einstein-Allee 23
    • 89081  Ulm
    • Germany
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    •   0049 731 500 54303
    •   0049 731 500 54304
    •   [---]*
    •   [---]*
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    • Maquet
    • Kehler Straße 31
    • 76437  Rastatt
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2014/02/27
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Trial Publications, Results and other Documents

  •   Anticoagulation management during multivessel coronary artery bypass grafting: a randomized trial comparing individualized heparin management and conventional hemostasis management.Hoenicka M, Rupp P, Müller-Eising K, Deininger S, Kunert A, Liebold A, Gorki H.J Thromb Haemost. 2015 May 7. doi: 10.1111/jth.12999
  •   Renal Function and Urinary Biomarkers in Cardiac Bypass Surgery: A Prospective Randomized Trial Comparing Three Surgical Techniques.
  •   Similarity of coagulation and inflammation despite different surgical revascularization strategies - a prospective randomized trial.
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* This entry means the parameter is not applicable or has not been set.