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Effect of Intrapulmonary Recombinant Human Activated Protein C (APC) on Coagulation and Inflammation After Lipopolysaccharide (LPS)

Information source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pneumonia; Lipopolysaccharides

Intervention: Drotrecogin alpha (Drug); Saline (NaCl 0.9%) (Drug); Endotoxin (Drug); Bronchoscopy (Procedure); Blood sampling (Procedure)

Phase: N/A

Status: Completed

Sponsored by: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Official(s) and/or principal investigator(s):
Tom Van der Poll, MD PhD, Principal Investigator, Affiliation: AMC/UvA Amsterdam

Summary

Recombinant human Activated Protein C (rhAPC) has been shown to reduce the mortality of patients with severe sepsis. The biological effects of APC are pleiotropic, and can be roughly divided in anticoagulant and cytoprotective effects. Lung infection and inflammation are associated with reduced bronchoalveolar levels of endogenous APC. Recent evidence derived from animal studies indicates that local administration of rAPC into the lungs exerts local anti-inflammatory and anticoagulant effects. In this study we propose to study the potential of locally administered APC, within a lung subsegment, to inhibit lipopolysaccharide (LPS) induced lung inflammation and coagulation in humans.

Clinical Details

Official title: Effect of Intrapulmonary Administration of Recombinant Human Activated Protein C on Local Coagulation and Inflammation After Bronchial Instillation of Lipopolysaccharide in Humans

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Primary outcome: To determine whether direct intrapulmonary delivery of rhAPC can inhibit LPS-induced lung inflammation, thereby avoiding systemic APC effects

Secondary outcome: 1. Neutrophil responses 2. Response of alveolar macrophages 3. Activation of the cytokine and chemokine network 4. Activation of coagulation and fibrinolysis

Eligibility

Minimum age: 18 Years. Maximum age: 35 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Male, 18-35 years of age

- No clinically significant findings during physical examination and hematological and

biochemical screening

- Normal spirometry and ECG

- Able to communicate well with the investigator and to comply with the requirements of

the study

- No medication

- Written informed consent

- No smoking

Exclusion criteria:

- Known diseases

- A history of smoking within the last six months, or regular consumption of greater

than three units of alcohol per day

- Administration of any investigational drug within 30 days of study initiation

- Donation of blood within 60 days, or loss of greater than 400 ml of blood within 12

weeks of study initiation

- History of enhanced bleeding tendency

- History of heparin-induced thrombocytopenia

- History of serious drug-related reactions, including hypersensitivity

Locations and Contacts

Academic Medical Center/ University of Amsterdam, Amsterdam 1100DD, Netherlands
Additional Information

Starting date: October 2008
Last updated: March 15, 2011

Page last updated: August 23, 2015

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