Trial document




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  DRKS00003178

Trial Description

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Title

Comparison of recent oxygenator with an integrated arteriel filter versus oxygenator with dynamic bubble trap without arterial filter

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

In patients undergoing coronary artery bypass surgery using the heart-lung machine (HLM) are often observed neurological deficits after surgery. The main causes of this operation-related complications can be attributed to micro air bubbles produced during the use of heart-lung machine. For this reason it is essential that these unavoidable air bubbles are filtered and eliminated as good as possible before entering the patient. The aim of this study is to determine the best configuration of the heart-lung machine with respect to the microbubble elimination. Here, a new oxygenator with integrated arterial filter is compared with an identical oxygenator without integrated arterial filter and the dynamic bubble trap.

With the help of a bubble counter "Gampt BCC200" the microbubbles are not only detected and counted, their size and volume is also measured. By the results derived from the bubble counter we can draw conclusions on the filtering method and its impact on the number of bubbles, the bubble size and bubble volume.

The determination of micro air bubbles through the bubble counter based on the ultrasonic echo method is non-invasive, non-encumbered, and there are no side effects and risks in the application of the Bubble Counters known. The sensor consists of an ultrasonic transmitter and ultrasonic receiver, which are placed before and after the oxygenator and the dynamic bubble trap outside the tubings.

Patients are divided here for a random process into two groups: Group 1: Heart-lung machine with an oxygenator with integrated arterial filter. Group 2: heart-lung machine with an oxygenator with integrated arterial filter without using dynamic bubble trap.

With the results of this study we could discover the best HLM-configuration with respect to the micro-bubble elimination in order to minimize postoperative risks.

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Brief Summary in Scientific Language

For operations using the heart-lung machine, it is inevitable that micro bubbles get into the bloodstream of the patient. With the help of an arterial filter or a dynamic bubble trap in the extracorporeal circuit, the numbers of micro air bubbles are reduced drastically. The aim of this study is to obtain a comparison of the two components ( arterial filter and dynamic bubble trap) in the CPB circuit and find the more efficient method for micro air bubble reduction. To measure the micro air bubbles the bubble counter Gampt BCC200 is used. The sensors of the BCC200 are mounted outside of the tubings before and after the oxygenator or the dynamic bubble trap and measure the micro-bubble activity by ultrasound. We expect to receive a statement which component is more efficient with respect to the micro-bubble elimination.

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Organizational Data

  •   DRKS00003178
  •   2011/07/19
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  •   yes
  •   Approved
  •   133/11, Ethik-Kommission der Albert-Ludwig-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   I25 -  Chronic ischaemic heart disease
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Interventions/Observational Groups

  •   configuration of the heart-lung-machine with the Terumo FX25 oxygenator with an integrated arterial filter
  •   configuration of the heart-lung-machine with the Terumo RX25 oxygenator without an integrated arterial filter with a dynamic bubble trap
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Other
  •   Parallel
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Primary Outcome

Primary outcome is the evaluation of the micro-bubble activity after stopping the heart-lung machine. The micro-bubbles are measured during CPB with the bubble counter Gampt BCC200. The numbers and the volume of the micro air bubbles before and after the oxygenator oxygenator/ the dynamic bubble trap are measured to compare the efficiency of the arterial filter and the dynamic bubble trap.

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Planned
  •   2011/07/31
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   30   Years
  •   85   Years
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Additional Inclusion Criteria

Patients undergoing coronary artery bypass surgery using the heart-lung machine

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Exclusion Criteria

Patients whose heart is opened during surgery, patients undergoing combined surgery (coronary heart disease with valve replacement or reconstruction)

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Addresses

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    • Universitätsklinik Freiburg, Abteilung für Herz- und Gefäßchirurgie
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
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    • Uniklinik Freiburg, Abteilung für Herz- und Gefäßchirurgie
    • Mr.  Prof. Dr.  Christian  Schlensak 
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
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    • Uniklinik Freiburg, Abteilung für Herz- und Gefäßchirurgie
    • Mr.  Prof. Dr.  Christian  Schlensak 
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Uniklinik Freiburg, Abteilung für Herz- und Gefäßchirurgie
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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