Activated Protein C in Severe Acute Pancreatitis

Overview

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.

Full Title of Study: “APCAP – Activated Protein C in Severe Acute Pancreatitis: A Double-blind Randomized Human Pilot Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: September 2007

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.

Interventions

  • Drug: Activated protein C
    • 24 micrograms/kg/hour intravenously for 96 hours

Arms, Groups and Cohorts

  • Experimental: Activated protein C

Clinical Trial Outcome Measures

Primary 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

Secondary Measures

  • Organ failure free days alive
    • Time Frame: 0-60 days

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Helsinki University Central Hospital
  • Provider of Information About this Clinical Study
    • Kemppainen Esko / M.D. PhD, Helsinki University Central Hospital
  • Overall Official(s)
    • Ville Pettilä, MD, PhD, Principal Investigator, Helsinki University Central Hospital

References

Bernard GR, Vincent JL, Laterre PF, LaRosa SP, Dhainaut JF, Lopez-Rodriguez A, Steingrub JS, Garber GE, Helterbrand JD, Ely EW, Fisher CJ Jr; Recombinant human protein C Worldwide Evaluation in Severe Sepsis (PROWESS) study group. Efficacy and safety of recombinant human activated protein C for severe sepsis. N Engl J Med. 2001 Mar 8;344(10):699-709. doi: 10.1056/NEJM200103083441001.

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