Trial document




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  DRKS00012781

Trial Description

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Title

Validation of a new dosing regimen for tranexamic acid in children under 1 year of age undergoing cardiac surgery

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Children undergoing cardiac surgery are reoutinely treated with tranexamic acid to prevent coagulatory disturbances. The treatment is performed by the standard protocol of our clinic. The topic of this study is to demonstrate, that throughout surgery the is always a therapeutically sufficient plasma concentration of tranexamic acid. Therefore alliquots of blood are taken at specific timepoints and tranexamic acid concentration in these aliquots willl be measured. The hypothesis is, that all values are within the therapeutic range of 20 - 125 µg/ml. In this pilot study we include 10 patients, the target population are children under one year of age.

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Brief Summary in Scientific Language

This study is an observative validation of the actual standard of care of the prophylactic use of tranexamic acid in children under 1 year of age undergoing cardiac surgery. The plasma concentration should be the therapeutic range between 20 - 125µg/ml

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Organizational Data

  •   DRKS00012781
  •   2017/11/02
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  •   yes
  •   Approved
  •   366/17 S, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München
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Secondary IDs

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Health Condition or Problem studied

  •   Q20-Q28 -  Congenital malformations of the circulatory system
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Interventions/Observational Groups

  •   Blood samples are taken for measurement of tranexamic acid plasma concentrations
    Timepoints: 5min after injection, 60min after injection, prior initiation of extracorporeal Circulation (ECC), 5 min ECC, 5 min after ECC, End of surgery
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   Yes
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Primary Outcome

Primary outcome is the testing of the overlap of the measured tranexamic acid concentration with the 90% confidence interval of the pharmacokinetc model.

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Secondary Outcome

Testing whether the tranexamic acid concentration is within the therapeutic range (20 - 125 µg/ml) throughout the entire surgical procedure.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/10/30
  •   10
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   1   Days
  •   1   Years
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Additional Inclusion Criteria

cardiac surgery requirin ECC, Age < 366 days

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Exclusion Criteria

-missing informed consent
-known disturbance of hemostasis
- preoperative treatment with medications affecting hemostasis
- hypersensitivity on tranexamic acid
- known renal insufficiency
- age _>366 days

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Addresses

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    • Institut für AnästhesiologieDt. Herzzentrum Müncen
    • Mr.  PD Dr.  Klaus  Martin 
    • Lazarettstr. 36
    • 80636  München
    • Germany
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    • Institut für AnästhesiologieDt. Herzzentrum München
    • Mr.  PD Dr.  Klaus  Martin 
    • Lazarettstr. 36
    • 80636  München
    • Germany
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    • Institut für AnästhesiologieDeutsches Herzzentrum München
    • Mr.  PD Dr.  Klaus  Martin 
    • Lazarettstraße 36
    • 80636  München
    • Germany
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Sources of Monetary or Material Support

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    • Institut für AnästhesiologieDt. Herzzentrum München
    • Lazarettstr. 36
    • 80636  München
    • Germany
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Status

  •   Recruiting ongoing
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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.