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Activated Protein C in Severe Acute Pancreatitis

This study has been completed.
Sponsor:
Information provided by:
Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01017107
First received: November 19, 2009
Last updated: October 13, 2010
Last verified: November 2009
History of Changes
  Purpose

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 Intervention Phase
Acute Pancreatitis
 Drug: Activated protein C
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: APCAP - Activated Protein C in Severe Acute Pancreatitis: A Double-blind Randomized Human Pilot Trial

Resource links provided by NLM:

MedlinePlus related topics: Pancreatitis
Drug Information available for: Protein C
U.S. FDA Resources

Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Organ failure free days alive [ Time Frame: 0-60 days ] [ Designated as safety issue: Yes ]

Enrollment: 32
Study Start Date: June 2003
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Activated protein C Drug: Activated protein C
24 micrograms/kg/hour intravenously for 96 hours

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01017107

Locations
Finland
Helsinki University Central Hospital
Helsinki, Finland, 00290
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
Principal Investigator: Ville Pettilä, MD, PhD Helsinki University Central Hospital
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Kemppainen Esko / M.D. PhD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01017107     History of Changes
Other Study ID Numbers: HUS 210284
Study First Received: November 19, 2009
Last Updated: October 13, 2010
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Helsinki University Central Hospital:
acute pancreatitis
treatment
organ failure
activated protein c

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Protein C
Anticoagulants
Hematologic Agents
 Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 16, 2013