A PRELIMINARY EVALUATION OF THE SAFETY PROFILE OF TWENTY-FOUR HOUR INFUSION OF HUMAN RECOMBINANT ACTIVATED PROTEIN C (XIGRIS) EARLY IN SEVERE ACUTE PANCREATITIS. - XIG-AP 1

Phase 1

• Conditions: Severe acute pancreatitis in man (with an APACHE II score of = 15) appears to carry a considerably higher risk of death when compared to general critical care patients with similar APACHE II scores. Current concepts of the pathophysiology of pancreatic necrosis suggest that disease progression is related to early activation of microvascular thrombotic pathways thus a theoretical case can be made for the use of activated protein C, early in the disease course of this illness; MedDRA version: 9.1 Level: LLT Classification code 10033647 Term: Pancreatitis acute

• Registration Number: EUCTR2007-003635-23-GB
• Lead Sponsor: Central Manchester and Manchester Children's Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-09-14
• Study Completion: 2011-10-19
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1.Acute pancreatitis – defined as acute abdominal pain with a threefold
elevation of serum amylase or a twofold elevation of serum lipase.
2.Severe disease – defined as an APACHE II score of = 15 on admission to hospital together with a logistic organ dysfunction score of = 2 within the first 24 hours of admission to hospital.
3.Early disease – defined as being within 72 hours of onset of severe pain.
4.No clinical evidence of haemorrhage
5.Patients with no prior history of bleeding duodenal ulcer, haemorrhagic stroke or other haemorrhagic diathesis.
6.Patients not taking warfarin or other anticoagulant medication.
7.Patients without evidence of end-stage renal disease
8.Patients who are not pregnant or lactating.
9.Over 18 years of age.
10.No surgery or endoscopic retrograde cholangiopancreatography (ERCP) within the previous 30 days.
11.Patients able to give informed consent (or complying with current United Kingdom criteria for consent in critical care unit trials).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Inability to give consent.
2.Non-severe acute pancreatitis – defined as an APACHE II score of < 15 on admission to hospital.
3.Later presentation: in excess of 72 hours after onset of severe pain.
4.Clinical evidence of haemorrhage.
5.Patients with a prior history of bleeding duodenal ulcer, haemorrhagic stroke or other haemorrhagic diathesis.
6.Patients taking warfarin or other anticoagulant medication. Thrombocytopenia, coagulopathy.
7.Patients with evidence of end-stage renal disease. Patients with liver disease.
8.Under 18 years of age.
9.Surgery or ERCP within the previous 30 days.
10.Patients who may be pregnant or lactating.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified