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Activated Protein C in Severe Acute Pancreatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01017107
Recruitment Status : Completed
First Posted : November 20, 2009
Last Update Posted : October 14, 2010
Information provided by:
Helsinki University Central Hospital

Brief Summary:

Activated protein C (APC)has been shown to reduce mortality in severe sepsis(Bernard et al. 2001b). The clinical picture of severe acute pancreatitis (AP) is similar to that of sepsis. The investigators conducted a randomised double-blinded placebo-controlled pilot study in AP patients (16+16) with the same dose of APC that has been proven to be efficacious and safe in septic patients.

The aim of the study is to investigate whether the APC replacement therapy diminishes the occurrence and severity of organ dysfunction in patients with severe AP. The effect of APC on inflammatory and hemostatic parameters is also assessed.

Condition or disease Intervention/treatment Phase
Acute Pancreatitis Drug: Activated protein C Phase 4

Detailed Description:
The study started in 2003 and was finished in 2007. The study was registered in The Helsinki University Central Hospital study register in 2003.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: APCAP - Activated Protein C in Severe Acute Pancreatitis: A Double-blind Randomized Human Pilot Trial
Study Start Date : June 2003
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis
Drug Information available for: Protein C

Arm Intervention/treatment
Experimental: Activated protein C Drug: Activated protein C
24 micrograms/kg/hour intravenously for 96 hours

Primary Outcome Measures :
  1. The primary safety endpoint was the number of bleedings, and the primary efficacy endpoint was the change in SOFA between the start of the drug (day 0) and day 5. [ Time Frame: 0-60 days ]

Secondary Outcome Measures :
  1. Organ failure free days alive [ Time Frame: 0-60 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Admitted to hospital within 72 h of the onset of pain.
  • Plasma amylase concentration more than three times the upper limit of the normal range and/or CT findings compatible with AP.
  • Organ failure and <48h of the onset of the first organ failure

Exclusion Criteria:

  • HIV / B- or C hepatitis infection
  • Pregnancy or breast feeding
  • Active bleeding
  • Increased risk of bleeding (thrombocytes <30x10E9/L or INR>3.0
  • Gastrointestinal bleeding within 6 weeks or intracranial stroke within 3 months before the study
  • Intravenous contrast extravasation or other signs (fresh hematoma) suggesting active hemorrhage within the pancreas or in the peripancreatic area on admission CT scan
  • Use of antithrombin III within 12 h
  • Use of acetylsalicylic acid or glycoprotein IIB/IA antagonist within 7 days / Thrombolytic therapy within 3 days
  • Surgery requiring general or spinal anaesthesia within 12 h
  • Previous pancreatic surgery
  • Application of an epidural catheter within 48 h

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01017107

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Helsinki University Central Hospital
Helsinki, Finland, 00290
Sponsors and Collaborators
Helsinki University Central Hospital
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Principal Investigator: Ville Pettilä, MD, PhD Helsinki University Central Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Kemppainen Esko / M.D. PhD, Helsinki University Central Hospital Identifier: NCT01017107    
Other Study ID Numbers: HUS 210284
First Posted: November 20, 2009    Key Record Dates
Last Update Posted: October 14, 2010
Last Verified: November 2009
Keywords provided by Helsinki University Central Hospital:
acute pancreatitis
organ failure
activated protein c
Additional relevant MeSH terms:
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Pancreatic Diseases
Digestive System Diseases
Drotrecogin alfa activated
Protein C
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents