Trial document




drksid header

  DRKS00006222

Trial Description

start of 1:1-Block title

Title

Gastroenterologic and endoscopic evaluation of patients before and after implantation of left-ventricular-assist-devices (LVAD)

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

GEPaD

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://-

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

After implantation of a left-ventricular assist device (LVAD) patients often complains of occult or overt gastrointestinal bleeding due to a combination of anticoagulation, laminar blood flow and the development of angiodysplastic lesions mainly in the small bowel.
The present study examines a standardized diagnostic approach to those patients using gastrointestinal endoscopy prior and after implantation of a LVAD-system with a follow-up period of 12 month.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The study includes all patients with planned LVAD-implantation prospectively and evalutes the rate of comorbidities in the gastrointestinal tract. The number of patients should be 50 and the follow up 12 month after implantation. the study should evaluate:
- the rate of patients with relevant comorbidities of the gastrointestinal tract before the implantation of the LVAD-device
- the bleeding rate after implantation of the device
- evaluation of the complication rate of endoscopic examinations in LVAD-patients
- evaluation of histopathological patterns of the mucosa before and after implantation of the LVAD-device

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00006222
  •   2014/12/17
  •   [---]*
  •   yes
  •   Approved
  •   Bo/18/2014, Ethikkommission bei der Ärztekammer Niedersachsen
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Gastrointestinal bleeding
  •   K92.2 -  Gastrointestinal haemorrhage, unspecified
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Endoscopic examinations of the upper and lower GI-tract before and 6 and 12 month after the implantation of a LVAD-device.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

the rate of patients with relevant comorbidities of the gastrointestinal tract before the implantation of the LVAD-device

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- the bleeding rate 6 and 12 month after implantation of the device
- evaluation of the complication rate of endoscopic examinations in LVAD-patients
- evaluation of histopathological patterns of the mucosa before and after implantation of the LVAD-device

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2015/01/01
  •   50
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

All patients with planned LVAD-implantation of the Schüchtermann-Klinik Bad Rothenfelde

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- age <18 years
- pregnancy
- participation in another trial 30 day before inclusion
- refused informed consent
- confused patients
- need for emergency implantation of the LVAD-device

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Innere Medizin / GastroenterologieMarienhospital
    • Mr.  Prof. Dr. med.  Michael K.  Müller 
    • Bischofstraße 1
    • 49074  Osnabrück
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   0541/326-4102
    •   0541/326-4703
    •   [---]*
    •   http://www.mho.de
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Klinik für Innere Medizin / Gastroenterologie
    • Mr.  Dr. med.  Oliver  Möschler 
    • Bischofstraße 1
    • 49074  Osnabrück
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Klinik für Innere Medizin / Gastroenterologie
    • Mr.  Dr. med.  Oliver  Möschler 
    • Bischofstraße 1
    • 49074  Osnabrück
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Klinik für Innere Medizin / GastroenterologieMarienhospital
    • Mr.  Prof. Dr. med.  Michael K.  Müller 
    • Bischofstraße 1
    • 49074  Osnabrück
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   0541/326-4102
    •   0541/326-4703
    •   [---]*
    •   http://www.mho.de
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting planned
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.