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Completed

NCT Number: NCT01017107

Activated Protein C in Severe Acute Pancreatitis

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.

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Key information

Conditions

Acute Pancreatitis Digestive System Diseases Pancreatic Diseases Pancreatitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Helsinki University Central Hospital

Helsinki, 00290, Finland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Activated protein C

Drug

24 micrograms/kg/hour intravenously for 96 hours

Primary outcomes

  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 outcomes

  1. Organ failure free days alive

    Time frame: 0-60 days

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

APCAP - Activated Protein C in Severe Acute Pancreatitis: A Double-blind Randomized Human Pilot Trial

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Nov 20, 2009
Registry last updated
Oct 14, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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