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Activated Protein C in Severe Acute Pancreatitis

NCT01017107 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2010-10-14

No results posted yet for this 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.

Conditions

Interventions

DRUG

Activated protein C

24 micrograms/kg/hour intravenously for 96 hours

Sponsors & Collaborators

  • Helsinki University Central Hospital

    lead OTHER

Principal Investigators

  • Ville Pettilä, MD, PhD · Helsinki University Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-06-30
Primary Completion
2007-09-30
Completion
2007-09-30

Countries

  • Finland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01017107 on ClinicalTrials.gov