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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 is not yet open for participant recruitment.
Verified October 2011 by Aalborg Universityhospital
Sponsor:
Collaborator:
Medtronic
Information provided by:
Aalborg Universityhospital
ClinicalTrials.gov Identifier:
NCT01462968
First received: October 17, 2011
Last updated: October 31, 2011
Last verified: October 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Aalborg Universityhospital:

Primary Outcome Measures:
  • Delta Thrombingeneration [ Time Frame: Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Platelet function [ Time Frame: Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01462968

Contacts
Contact: Susanne de Neergaard, Perfusionist 0045 99322996 s.neergaard@rn.dk
Contact: Jan Jesper Andreasen, head of department, MD, PhD 0045 99322964 jja@rn.dk

Locations
Denmark
Aalborg Hospital Not yet recruiting
Aalborg, Denmark, 9000
Sponsors and Collaborators
Aalborg Universityhospital
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

No publications provided

ClinicalTrials.gov Identifier: NCT01462968     History of Changes
Other Study ID Numbers: N-20110037
Study First Received: October 17, 2011
Last Updated: October 31, 2011
Health Authority: Denmark: Danish Dataprotection Agency (2008-58-0028)
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Aalborg Universityhospital:
Heparin treatment during cardiac surgery
Heparin reversal after cardiac surgery
Thrombin generation
Endogenous Thrombin potential

Additional relevant MeSH terms:
Calcium heparin
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
 Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 22, 2013