Ignite Creation Date:
2024-05-05 @ 10:03 PM
Last Modification Date:
2024-10-26 @ 10:13 AM
Study NCT ID:
NCT01017107
Status:
COMPLETED
Last Update Posted:
2010-10-14
First Post:
2009-11-19
Brief Title:
Activated Protein C in Severe Acute Pancreatitis
Sponsor:
Helsinki University Central Hospital
Organization:
Helsinki University Central Hospital
Study Overview
Official Title:
APCAP - Activated Protein C in Severe Acute Pancreatitis A Double-blind Randomized Human Pilot Trial
Status:
COMPLETED
Status Verified Date:
2009-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Activated protein C APChas been shown to reduce mortality in severe sepsisBernard 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 1616 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None