Activated Protein C in Severe Acute Pancreatitis

NCT01017107 — Phase 4, Completed, 32 participants, Helsinki University Central Hospital

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

Registry	NCT01017107
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, single group, masking: double, treatment
Enrollment	32 (Actual)
Sponsor	Helsinki University Central Hospital (Other)
Conditions	Acute Pancreatitis
Interventions	Activated protein C (Drug)
Dates	start 2003-06-01, primary completion 2007-09-01, completion 2007-09-01, first posted 2009-11-20, last updated 2010-10-14
Locations	1 site in Finland

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Activated protein C	Experimental	Drug: Activated protein C

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

+Outcome measures

Primary outcomes

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]

Secondary outcomes

Organ failure free days alive [0-60 days]

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Helsinki University Central Hospital	Helsinki	Finland

+Publications

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. PMID 11236773
Results publication: 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. PMID 20663207

+Investigators

Ville Pettilä, MD, PhD, Principal investigator, Helsinki University Central Hospital