Trial document




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  DRKS00012480

Trial Description

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Title

Treatment Of Gastrointestinal Bleeding With PuraStat® - Prospective Multicenter-Pilotstudy For The Use of Purastat® for GI-Bleeding

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Trial Acronym

PuraStat®

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In a pilot study Patients with gastrointestinal (GI) bleeding Forrest Ib - IIc were treated with PuraStat®. This new method should be used if conventional methods for achieving a bleeding stop failed or after continuing bleeding activity after primary treatment. The aim of the present study is to improve the bleeding management in diffuse or large-area bleeding or in anatomic regions difficult to reach.

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Brief Summary in Scientific Language

PuraStat® is a hemostatic gel approved for the use wihin emergency endoscopies in gastrointestinal bleeding. Participating Centers (approx. 25) will apply and evaluate the gel during their routine emergency endoscopy program. The primary hypothesis is the final achievement of a bleeding stop.

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Organizational Data

  •   DRKS00012480
  •   2017/07/13
  •   [---]*
  •   yes
  •   Approved
  •   EA4/082/17, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   K21.0 -  Gastro-oesophageal reflux disease with oesophagitis
  •   K25.0 -  Gastric ulcer; Acute with haemorrhage
  •   K27.0 -  Peptic ulcer, site unspecified; Acute with haemorrhage
  •   K63.3 -  Ulcer of intestine
  •   K92.2 -  Gastrointestinal haemorrhage, unspecified
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Interventions/Observational Groups

  •   single-arm multicenter-study for the use of PuraStat® as a method to achieve bleeding stop and for the indication bleeding prophylaxis
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   IV
  •   N/A
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Primary Outcome

Achievement of a sufficient bleeding stop by PuraStat®

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Secondary Outcome

Reduction of the re-bleeding rate, documentation of the risk profile and complication rate of PuraStat®

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/07/01
  •   97
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Inclusion criteria were:
All gastrointestinal bleedings between Forrest Ib-IIc and lower, large-area bleedings, diffuse bleedings.
Subgroup for Forrest Ia bleeding (decision of the treating physician), signed consent of the patients if possible, patients between 18-80 years

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Exclusion Criteria

Forrest IA-bleedings should be treated conventionally. If the physician recognized an indication for the use of PuraStat® in Forrest IA-bleeding these patients were analyzed as a subgroup

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Addresses

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    • Charité Campus Benjamin Franklin
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
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    • Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektiologie, RheumatologieZentrale Endoskopioe
    • Mr.  PD Dr.  Christian  Bojarski 
    • Hindenburgdamm 30
    • 12200  Berlin
    • Germany
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    • Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektiologie, RheumatologieZentrale Endoskopioe
    • Mr.  PD Dr.  Christian  Bojarski 
    • Hindenburgdamm 30
    • 12200  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Charité Campus Benjamin Franklin
    • Hindenburgdamm 30
    • 12203  Berlin
    • 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.