The influence of the surgical technique and the method of coagulation monitoring on changes in the coagulation system during coronary artery bypass grafting operations
Organizational Data
- DRKS-ID:
- DRKS00007580
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2014-12-03
- Last update in DRKS:
- 2022-09-07
- Registration type:
- Retrospective
Acronym/abbreviation of the study
HEPCON
URL of the study
No Entry
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.
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.
Health condition or problem studied
- ICD10:
- I25.9 - Chronic ischaemic heart disease, unspecified
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 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.
- Arm 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.
- Arm 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.
Endpoints
- Primary outcome:
- total heparin and protamine dose during operation
- 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.
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Klinik für Herz-, Thorax- und Gefäßchirurgie Ulm
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2013-01-25
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2014-02-27
- Target Sample Size:
- 120
- Final Sample Size:
- 120
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 85 Years
- 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
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)
Addresses
Primary Sponsor
- Address:
- Univeristät UlmKlinik für Herz-, Thorax- undGefäßchirurgieDr. med. Hagen GorkiAlbert-Einstein-Allee 2389081 UlmGermany
- Telephone:
- 0049 731 500 54405
- Fax:
- 0049 731 500 54304
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- No
Contact for Scientific Queries
- Address:
- Univeristät UlmKlinik für Herz-, Thorax- undGefäßchirurgieDr. med. Hagen GorkiAlbert-Einstein-Allee 2389081 UlmGermany
- Telephone:
- 0049 731 500 54405
- Fax:
- 0049 731 500 54304
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Univeristät UlmKlinik für Herz-, Thorax- undGefäßchirurgieDr. med. Hagen GorkiAlbert-Einstein-Allee 2389081 UlmGermany
- Telephone:
- 0049 731 500 54400
- Fax:
- 0049 731 500 54304
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Univeristät UlmKlinik für Herz-, Thorax- undGefäßchirurgieDr. med. Hagen GorkiAlbert-Einstein-Allee 2389081 UlmGermany
- Telephone:
- 0049 731 500 54405
- Fax:
- 0049 731 500 54304
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- MaquetKehler Straße 3176437 RastattGermany
- Telephone:
- +49 7222 932-0
- Fax:
- +49 7222 932 855
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.maquet.com/de
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- Medtronic GmbHEarl-Bakken-Platz 140670 MeerbuschGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Universitätsklinik UlmKlinik für Herz-, Thorax- und GefäßchirurgieAlbert-Einstein-Allee 2389081 UlmGermany
- Telephone:
- 0049 731 500 54303
- Fax:
- 0049 731 500 54304
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Universität UlmHelmholtzstr. 2089081 UlmGermany
- Telephone:
- +49-731-50022050
- Fax:
- +49-731-50022036
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2012-08-31
- Ethics committee number:
- 264/12
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2012-11-15
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- 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.
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry