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Activated Protein C in Severe Acute Pancreatitis

Primary Purpose

Acute Pancreatitis

Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Activated protein C
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pancreatitis focused on measuring acute pancreatitis, treatment, organ failure, activated protein c

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Helsinki University Central Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Activated protein C

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Organ failure free days alive

Full Information

First Posted
November 19, 2009
Last Updated
October 13, 2010
Sponsor
Helsinki University Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01017107
Brief Title
Activated Protein C in Severe Acute Pancreatitis
Official Title
APCAP - Activated Protein C in Severe Acute Pancreatitis: A Double-blind Randomized Human Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Helsinki University Central Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pancreatitis
Keywords
acute pancreatitis, treatment, organ failure, activated protein c

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Activated protein C
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Activated protein C
Intervention Description
24 micrograms/kg/hour intravenously for 96 hours
Primary Outcome Measure Information:
Title
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.
Time Frame
0-60 days
Secondary Outcome Measure Information:
Title
Organ failure free days alive
Time Frame
0-60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ville Pettilä, MD, PhD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
00290
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
11236773
Citation
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.
Results Reference
background
PubMed Identifier
20663207
Citation
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.
Results Reference
derived

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Activated Protein C in Severe Acute Pancreatitis

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