Trial document





This trial has been registered retrospectively.
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  DRKS00013512

Trial Description

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Title

Influence of retrograde autologous priming (RAP) on the safety and efficacy of cardiopulmonary bypass (CPB) and transfusion requirements

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

In this study patients who have to undergo open-heart surgery with heart-lung-machine due to coronary arterie or heart valve disease (aortic valve disease) will be included. In the project part of the filling volume of the heart-lung-machine will be replaced at the beginning of surgery with the patient's own blood. This method is called retrograde autologous priming. The reduced fill volume is collected in a RAP bag connected to the heart-lung-machine. The intension of the study is to reduce the negative effects of the heart-lung- machine such as inflammatory response, blood thinning, blood clotting disorders and blood transfusions.

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Brief Summary in Scientific Language

The project will require the replacement of part of the crystalloid cardiopulmonary priming solution in patients with coronary artery disease or aortic valve disease undergoing open heart surgery using the cardiopulmonary bypass (CPB) machine at the beginning of surgery with the patient's own blood, both retrograde and antegrade flow direction via the venous and arterial cannula done. This procedure is known as Retrograde Autologous Priming (RAP). The reduced crystalloid filling volume of the perfusion circuit leads to a lower intraoperative hemodilution of the patient and allows the retention of higher hematocrit values during the operation. Since the intraoperative hematocrit value acts as a trigger for homologous blood transfusion, the RAP technique should increase the safety of cardiopulmonary bypass with extracorporeal circulation and reduce the associated costs, both the direct cost of blood transfusions and the cost of treatment for the associated side effects. The newly introduced RAP bag (Terumo) was developed for the above-mentioned RAP procedure in conjunction with a conventional CPB system with the intention to reduce negative effects such as inflammatory response, hemolysis, hemodilution, blood clotting disorders and post-operative complications. The RAP study is a prospective, monocentric, randomized clinical trial designed to assess the safety and efficacy of the RAP procedure and the suitability of the CE certified TERUMO RAP bag.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00013512
  •   2017/12/04
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  •   yes
  •   Approved
  •   2012-7, Ethikkommission der Medizinischen Fakultät der Martin-Luther-Universität Halle Wittenberg
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Secondary IDs

  •   RAP 18080  (Forschungsportal Sachsen-Anhalt (https://forschung-sachsen-anhalt.de/))
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Health Condition or Problem studied

  •   I25.1 -  Atherosclerotic heart disease
  •   I35.0 -  Aortic (valve) stenosis
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Interventions/Observational Groups

  •   retrograde autologous priming (RAP) group
  •   non retrograde autologous priming (Non-RAP) group
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Other
  •   Parallel
  •   N/A
  •   No
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Primary Outcome

Reduction of the need for intraoperative blood transfusion through the use of the RAP bag for retrograde autologous priming compared to conventional priming in patients undergoing cardiac surgery for the treatment of coronary heart disease or aortic valve defect.

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Secondary Outcome

SAFETY
• Absence of complications related to the priming technique used
• Bleeding and reoperation for bleeding (excluding patients with a surgical cause for reoperation)
• Post-operative atrial fibrillation (defined as any arrhythmia requiring treatment and / or irregular rhythm and missing P wave identified by ECG)

EFFECTIVENESS
• Transfusion needs
• Reduction of the filling volume of the perfusion circuit
• Inflammatory reaction (standard parameters)
• Intubation time
• Duration of stay in the intensive care unit
• Length of hospital stay

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/08/23
  •   130
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
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Additional Inclusion Criteria

1. Patient is older than 18 years.
2. Patient has coronary heart disease or aortic valve defect and is a suitable candidate for cardiopulmonary bypass (CPB) surgery.
3. Patient has been informed about the study and has given his written consent.

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Exclusion Criteria

1. Ejection fraction ≤ 20%
2. Re-operation
3. Acute endocarditis
4. Acute myocardial infarction within 24 hours before the procedure, calculated on the onset of symptoms.
5. Known pre-operative presence of intracardiac thrombi
6. Stenosis of an internal carotid artery > 70%
7. Dialysis
8. Malignant disease or immunological diseases
9. Taking Marcumar, preoperative continuous heparin infusion or known coagulopathy
10. Thrombocytopenia (<100 Gpt/l)
11. Patients after pre-operative own blood donation
12. Taking steroids
13. Participation in another study

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Addresses

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    • Universitätsklinikum Halle (Saale)Klinik und Poliklinik für Herzchirurgie
    • Ernst-Grube-Strasse 40
    • 06120  Halle
    • Germany
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    • Universitätsklinikum Halle (Saale)Klinik und Poliklinik für Herzchirurgie
    • Ms.  PD Dr. med.  Britt  Hofmann 
    • Ernst-Grube-Strasse 40
    • 06120  Halle
    • Germany
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    • Universitätsklinikum Halle (Saale)Klinik und Poliklinik für Herzchirurgie
    • Ms.  PD Dr. med.  Britt  Hofmann 
    • Ernst-Grube-Strasse 40
    • 06120  Halle
    • Germany
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Sources of Monetary or Material Support

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    • TERUMO Europe NV
    • Interleuvenlaan 40
    • 3001  Leuven
    • Belgium
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Status

  •   Recruiting complete, follow-up complete
  •   2015/10/21
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.