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

June 25, 2015 updated by: Jan Jesper Andreasen, Professor, MD, PhD, Aalborg University Hospital

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Aalborg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
  • HMS
  • Hemochron Signature Elite
  • Hepcon
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
  • HMS
  • Hemochron Signature Elite
  • Hepcon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours.
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
Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours.
Standard coagulationtests
Time Frame: Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours.
Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aalborg University Hospital

Collaborators

Medtronic

Investigators

  • Principal Investigator: Susanne de Neergaard, Perfusionist, Heart-Lung surgery unit, Aalborg Hospital, Aarhus University Hospital, Hobrovej 18-22, DK-9000 Aalborg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Anticipated)

March 1, 2012

Study Completion (Anticipated)

March 1, 2012

Study Registration Dates

First Submitted

October 17, 2011

First Submitted That Met QC Criteria

October 31, 2011

First Posted (Estimate)

November 1, 2011

Study Record Updates

Last Update Posted (Estimate)

June 26, 2015

Last Update Submitted That Met QC Criteria

June 25, 2015

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-20110037

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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