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CompletedNCT01017107Updated Oct 14, 2010

Activated Protein C in Severe Acute Pancreatitis

A Phase 4 interventional study of Activated protein C in Acute Pancreatitis, sponsored by Helsinki University Central Hospital. Completed at 1 site in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-10-14.

Sponsored by Helsinki University Central Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Acute Pancreatitis

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Keywords

  • acute pancreatitis
  • treatment
  • organ failure
  • activated protein c
03

In context

Pancreatitis

759 studies on the registry are indexed under Pancreatitis; 181 are open to participants now.

This study's enrollment of 32 is below the median of 80 across 450 interventional studies indexed under Pancreatitis.

Browse Pancreatitis studies →

Lead sponsor

Helsinki University Central Hospital is the lead sponsor of 311 studies on the registry; 61 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Activated protein C

    Drug: Activated protein C

Interventions

06

What researchers measure

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

07

Study locations

1 site
  • Helsinki University Central Hospital
    Helsinki, 00290, Finland
08

References and documents

Publications

  • 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. PubMed 11236773 ↗
  • Pettila V, Kyhala L, Kylanpaa ML, Leppaniemi A, Tallgren M, Markkola A, Puolakkainen P, Repo H, Kemppainen E. APCAP--activated protein C in acute pancreatitis: a double-blind randomized human pilot trial. Crit Care. 2010;14(4):R139. doi: 10.1186/cc9203. Epub 2010 Jul 27. PubMed 20663207 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01017107
Lead sponsor
Helsinki University Central Hospital
First posted
Nov 20, 2009
Start date
Jun 2003
Primary completion
Sep 2007
Completion
Sep 2007
Last update
Oct 14, 2010

Study contacts

Ville Pettilä, MD, PhD
principal investigator · Helsinki University Central Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2009. You cannot join it, but the record below documents what was studied.

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