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Interruptions in the Coagulationsystem in Relation With Cardiac Surgery - A Study Comparing Two Heparinization Strategies During On-pump Cardiac Surgery

This study has been withdrawn prior to enrollment.
(The study never started due to problems with Laboratory facilities in collaborating center)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01462968
First Posted: November 1, 2011
Last Update Posted: June 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medtronic
Information provided by (Responsible Party):
Jan Jesper Andreasen, Professor, MD, PhD, Aalborg Universitetshospital
  Purpose

The purpose of this study is to find the heparinization method, which

  1. affect the heparin-protaminsulfate ratio in the best way to achieve haemostasis
  2. gives the smallest change in endogenous thrombin potential (ETP)postoperative compared to preoperative (deltaETP) as an indicator for haemostatic activation during cardiac surgery.

The hypothesis is that the deltaETP is larger in the Haemochron Signature Elite group than in the Hepcon-group because of the heparinization-method. Therefore there is a potential higher risk for use of bloodproducts postoperatively.


Condition Intervention
Cardiac Surgery Device: Activated clotting time versus blood-heparin concentration

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Interruptions in the Coagulationsystem in Relation With Cardiac Surgery -A Randomized Study Comparing Two Heparinization Strategies During On-pump Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Jan Jesper Andreasen, Professor, MD, PhD, Aalborg Universitetshospital:

Primary Outcome Measures:
  • Delta Thrombingeneration [ Time Frame: Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours. ]
    Postoperative versus preoperative thrombingeneration evaluated by Endogenous Thrombin Potential,peak Thrombin level and Lagtime by using a Thromboscope


Secondary Outcome Measures:
  • peroperative heparine/protaminesulphate ratio [ Time Frame: The timeframe is from the first heparin is given to the neutralization with protamine sulfate, average time 4 hours ]
  • Platelet function [ Time Frame: Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours. ]
    Platelet aggregation measured by Multiplate platelet function analyzer

  • Thromboelastometry [ Time Frame: Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours. ]
    We are looking at the parameters: Clottingtime, Clot formation time and maximum velocity,maximum clot firmness

  • Standard coagulationtests [ Time Frame: Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours. ]

Enrollment: 0
Study Start Date: November 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Activated clotting time (ACT) group
heparinization measured as activated clotting time during surgery
Device: Activated clotting time versus blood-heparin concentration
Activated clotting time used for heparinization strategy during cardiag surgery versus blood-heparin concentration
Other Names:
  • ACT
  • Hemochron Signature Elite
  • Hepcon
  • HMS
Experimental: Hepcon group
heparinization measured as heparin concentration in the blood during surgery
Device: Activated clotting time versus blood-heparin concentration
Activated clotting time used for heparinization strategy during cardiag surgery versus blood-heparin concentration
Other Names:
  • ACT
  • Hemochron Signature Elite
  • Hepcon
  • HMS

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective on-pump coronary artery bypass grafting (CABG) single procedure
  • Elective aortavalve replacement (AVR) (single procedure)

Exclusion Criteria:

  • Emergency procedures
  • Children and youngsters less than 18 years
  • Pregnancy
  • Less than 2 days break with platelet inhibiting drugs (acetylsalicylic acid, NSAID, clopidogrel, serotonin reuptake inhibitors)
  • Less than 2 days break with AC-treatment (warfarin, heparin, coumarin etc)
  • Known coagulopathy
  • Endocarditis
  • Preoperative anaemia
  • Dialysis patients
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01462968


Locations
Denmark
Aalborg Hospital
Aalborg, Denmark, 9000
Sponsors and Collaborators
Aalborg Universitetshospital
Medtronic
Investigators
Principal Investigator: Susanne de Neergaard, Perfusionist Heart-Lung surgery unit, Aalborg Hospital, Aarhus University Hospital, Hobrovej 18-22, DK-9000 Aalborg
  More Information

Responsible Party: Jan Jesper Andreasen, Professor, MD, PhD, Professor, Aalborg Universitetshospital
ClinicalTrials.gov Identifier: NCT01462968     History of Changes
Other Study ID Numbers: N-20110037
First Submitted: October 17, 2011
First Posted: November 1, 2011
Last Update Posted: June 26, 2015
Last Verified: October 2011

Keywords provided by Jan Jesper Andreasen, Professor, MD, PhD, Aalborg Universitetshospital:
Heparin treatment during cardiac surgery
Heparin reversal after cardiac surgery
Thrombin generation
Endogenous Thrombin potential

Additional relevant MeSH terms:
Calcium heparin
Heparin
Thrombin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants