Trial document




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  DRKS00014265

Trial Description

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Title

Selective depletion of C-reactive protein by means of therapeutic apheresis (CRP-apheresis) in acute pancreatitis

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Trial Acronym

CAPRI1

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URL of the Trial

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Brief Summary in Lay Language

CAPR1 is a clinical trial to evaluate the safety and efficacy of the reduction of C-reactive protein (CRP) by therapeutic apheresis (CRP-apheresis) in patients with acute pancreatitis.
The term therapeutic apheresis describes therapeutical procedures whose effect is based on the elimination of blood components with a pathogenic function within the disease process. Elimination takes place in adsorbers outside the body in an extracorporeal circuit. To remove the pathogenic substances, blood plasma is separated from the circuit and passed through an adsorber. The purified blood plasma is then reunited with the solid blood components and returned to the patient.
The "PentraSorb® CRP" adsorber used for CRP-apheresis is CE-certified for the selective depletion of the C-reactive protein from human plasma.
As a cause of the damaging effect of C-reactive protein, it is assumed that CRP (as an inflammatory mediator) favours the destruction of pancreatic tissue (in conjunction with complement) and negatively influences the regeneration of the traumatized tissue.
The aim of the CAPR1 study is to investigate, if the pancreatic tissue damage can be reduced by depletion of the C-reactive protein in acute inflammation.
A potential protective effect of CRP apheresis on pancreatic tissue injury is to be determined by the course of the disease (determined by laboratory biomarkers like interleukin 6, imaging studies and various score systems such as APACHE II, Sofa, Balthazar) and the occurrence of secondary complications over 6 months.

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Brief Summary in Scientific Language

The CAPR1 study is conducted open, controlled, randomized and monocentric. The efficacy and tolerability of CRP apheresis in patients with acute pancreatitis is investigated.

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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

  •   DRKS00014265
  •   2018/03/12
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  •   no
  •   Approved
  •   168/17 I, Ethikkommission der Ärztekammer Schleswig-Holstein (Ethik-Kommission I)
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Secondary IDs

  •   U1111-1210-5221 
  •   CIV-17-12-022444 
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Health Condition or Problem studied

  •   K85.80 -  [generalization K85.8: Other acute pancreatitis]
  •   K85.91 -  [generalization K85.9: Acute pancreatitis, unspecified]
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Interventions/Observational Groups

  •   10 patients with acute pancreatitis receive up to seven apheresis treatments (every 24±12 hrs) starting 24±12 hrs after diagnosis of acute pancreatitis
  •   10 patients with necrotizing pancreatitis receive up to seven apheresis treatments (every 24±12 hrs) starting within 24 hrs after diagnosis of the necrotizing form
  •   2 x 10 patients of the control groups receive the standard treatment of acute pancreatitis
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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)
  •   Treatment
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Safety and tolerability of CRP-apheresis in acute pancreatitis (incidence of expected and unexpected adverse effects of CRP-apheresis)

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Secondary Outcome

Course of the disease (Progression of necrosis, time on ICU, hospitalization, APACHE II, Sofa Score, BISAP (Bedside Index for Severity in Acute Pancreatitis), CORE-10-TISS (Therapeutic Intervention Scoring System), Balthazar Score, Pseudocysts, Infection Rate, Endoscopic or Surgical Procedures)
Secondary complications over 6 months (Exocrine pancreatic insufficiency, new onset of diabetes mellitus)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2018/09/01
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

• Acute pancreatitis
• BISAP ≥ 3 or
• Ranson score ≥ 3 or
• Apache II Score > 8
• CRP ≥ 150 mg/L and/or
• interleukin 6 ≥ 150 pg/mL and/or
• procalcitonin ≥ 2 ng/L
• written informed consent
• legal competence
• Balthazar score> 5 (group 2 only (evidence of necrosis))

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Exclusion Criteria

• Age <18 ≥ 80 years
• Therapy refractory shock
• Known hypersensitivity to therapeutic aphereses
• Pregnancy or breastfeeding
• Participation in other interventional trials

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Addresses

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    • Pentracor GmbH
    • Neuendorfstr. 23b/d
    • 16761  Hennigsdorf
    • Germany
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    • Pentracor GmbH
    • Dr.  Burghard  Thiesen 
    • Neuendorfstr. 23 b/d
    • 16761  Hennigsdorf
    • Germany
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    • Diakonissenkrankenhaus Medizinische Klinik – Innere Medizin
    • Dr.  Wolfgang  Ries 
    • Knuthstraße 1
    • 24939  Flensburg
    • Germany
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    •   +49 461 812 1308
    •   +49 461 812 1304
    •   rieswo at diako.de
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Sources of Monetary or Material Support

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    • Pentracor GmbH
    • Neuendorfstr. 23 b/d
    • 16761  Hennigsdorf
    • 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.