Trial document





This trial has been registered retrospectively.
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  DRKS00003707

Trial Description

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Title

thrombin occlusion in case of aneuyrsm spurium - a retrospective analysis

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Retrospective analysis of patients, treated with occlusion with thrombin in case of aneurysma spurium. Occlusions with thrombin are in case of an aneurysma spurium well established procedure at the university hospital Freiburg. The data was collected in a database.
We want to look at the success of this treatment. The database will be used on the one hand to look at the primary success on the other hand we and to look at the longterm survival of these patients. We want to compare the collected data with data already collected in the FRIS database, this data will be used as the control group.
Beside that we do a follow up by phone, we will contact the patients to evaluate if there are still problems after the occlusion, if there was a relapse of the aneurysma spurim and if there complications with the vessels after the occlusion such as a thrombosis or arterial occlusion.
We expect looking at the data that we can make a prediction about the long-term success and the complications of these occlusions with thrombin.

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Brief Summary in Scientific Language

Retrospective analysis of patients, treated with occlusion with thrombin in case of aneurysma spurium. Occlusions with thrombin are in case of an aneurysma spurium well established procedure at the university hospital Freiburg.
The data will be collected in a database.
We want to look at the success of this treatment. The database will be used on the one hand to look at the primary success of the occlusion on the other hand we and to look at the longterm survival of these patients. We want to compare the collected data with data already collected in the FRIS database, this data will be used as the control group. We compare those groups using an Kaplan Meier estimator after we performed a propensity score matching.
Beside that we do a follow up by phone, we will contact the patients to evaluate if there are still problems after the occlusion, if there was a relapse of the aneurysma spurim and if there complications with the vessels after the occlusion such as a thrombosis or arterial occlusion.
We expect looking at the data that we can make a prediction about the long-term success and the complications of these occlusions with thrombin.

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Organizational Data

  •   DRKS00003707
  •   2013/08/14
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  •   yes
  •   Approved
  •   55/12, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   aneurysm spurium
  •   I72.9 -  Aneurysm and dissection of unspecified site
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Interventions/Observational Groups

  •   patients with an aneurysma spurium after an occlusion using thrombin; those had received an arterial puncture during a procedure before;
  •   patients after arterial puncture, who had no aneurysma spurium afterwards
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Treatment
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

survival after ithrombinocclusion

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Secondary Outcome

successrate of the thrombin occlusion

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/10/01
  •   550
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

made thrombin occlusion in a age older 18

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Exclusion Criteria

exclusion, if no confimered consent for the folloqw up

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Addresses

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    • Universitätsklinik Freiburg, Medizin III Angiologie
    • Mr.  Dr. med.  Bonaventura  Schmid 
    • Hugstetter strasse 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinik Freiburg, Medizin III Angiologie
    • Mr.  Dr. med.  Bonaventura  Schmid 
    • Hugstetter strasse 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinik Freiburg, Medizin III Angiologie
    • Mr.  Dr. med.  Bonaventura  Schmid 
    • Hugstetter strasse 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg Medizin III / Kardiologie und Angiologie Interdisziplinäres Gefäßzentrum
    • Hugstetterstrasse 55
    • 79104  Freiburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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