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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01017107
• Other study ID #: HUS 210284
• Status: Completed
• Phase: Phase 4
• First received: November 19, 2009
• Last updated: October 13, 2010
• Start date: June 2003
• Est. completion date: September 2007

Study information

• Verified date: November 2009
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Intervention

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

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Organ failure free days alive		0-60 days	Yes