Activated Protein C in Severe Acute Pancreatitis

NCT ID: NCT01017107

Last Updated: 2010-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2007-09-30

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.

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.

Conditions

Acute Pancreatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Activated protein C

Group Type: EXPERIMENTAL

Activated protein C

Intervention Type: DRUG

24 micrograms/kg/hour intravenously for 96 hours

Interventions

Activated protein C

24 micrograms/kg/hour intravenously for 96 hours

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helsinki University Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Helsinki University Central Hospital

Principal Investigators

Ville Pettilä, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Locations

Helsinki University Central Hospital

Helsinki, , Finland

Countries

Finland

References

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.

Reference Type: BACKGROUND

PMID: 11236773 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 20663207 (View on PubMed)

Other Identifiers

HUS 210284

Identifier Type: -

Identifier Source: org_study_id