Activated Protein C in Severe Acute Pancreatitis

Acute Pancreatitis Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

• NCT number: NCT01017107
• Study type: Interventional
• Source: Helsinki University Central Hospital
• Status: Completed
• Phase: Phase 4
• Start date: June 2003
• Completion date: September 2007