NCT01017107

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2003

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 20, 2009

Completed
Last Updated

October 14, 2010

Status Verified

November 1, 2009

Enrollment Period

4.3 years

First QC Date

November 19, 2009

Last Update Submit

October 13, 2010

Conditions

Acute Pancreatitis

Keywords

acute pancreatitistreatmentorgan failureactivated protein c

Outcome Measures

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.

    0-60 days

Secondary Outcomes (1)

  • Organ failure free days alive

    0-60 days

Study Arms (1)

Activated protein C

EXPERIMENTAL
Drug: Activated protein C

Interventions

Activated protein CDRUG

24 micrograms/kg/hour intravenously for 96 hours

Activated protein C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Central Hospital

Helsinki, 00290, Finland

Location

Related Publications (2)

  • 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.

    PMID: 11236773BACKGROUND

  • 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.

    PMID: 20663207DERIVED

MeSH Terms

Conditions

Pancreatitis

Interventions

Protein C

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Enzyme PrecursorsEnzymes and CoenzymesGlycoproteinsGlycoconjugatesCarbohydratesBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsProtein PrecursorsBlood Coagulation Factor InhibitorsBiological Factors

Study Officials

  • Ville Pettilä, MD, PhD

    Helsinki University Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 19, 2009

First Posted

November 20, 2009

Study Start

June 1, 2003

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

October 14, 2010

Record last verified: 2009-11

Locations

FI(1)