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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pneumonia Lipopolysaccharides

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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Activated protein C

Group Type EXPERIMENTAL

Drotrecogin alpha

Intervention Type DRUG

Drotrecogin alpha is given intrabronchially by bronchoscopy at t=0

Endotoxin

Intervention Type DRUG

Endotoxin (4 ng/kg body weight) is given intrabronchially in one subsegment at t=0

Bronchoscopy

Intervention Type PROCEDURE

Bronchoscopies are performed at t=0 (for instillation of LPS and Drotrecogin alpha) and at t=6 (for performing a bronchoalveolar lavage)

Blood sampling

Intervention Type PROCEDURE

Blood sampling is done by venapuncture at t=0 and t=6

Saline

Group Type PLACEBO_COMPARATOR

Saline (NaCl 0.9%)

Intervention Type DRUG

Normal saline is given intrabronchially by bronchoscopy at t=0

Endotoxin

Intervention Type DRUG

Endotoxin (4 ng/kg body weight) is given intrabronchially in one subsegment at t=0

Bronchoscopy

Intervention Type PROCEDURE

Bronchoscopies are performed at t=0 (for instillation of LPS and Drotrecogin alpha) and at t=6 (for performing a bronchoalveolar lavage)

Blood sampling

Intervention Type PROCEDURE

Blood sampling is done by venapuncture at t=0 and t=6

Interventions

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Drotrecogin alpha

Drotrecogin alpha is given intrabronchially by bronchoscopy at t=0

Intervention Type DRUG

Saline (NaCl 0.9%)

Normal saline is given intrabronchially by bronchoscopy at t=0

Intervention Type DRUG

Endotoxin

Endotoxin (4 ng/kg body weight) is given intrabronchially in one subsegment at t=0

Intervention Type DRUG

Bronchoscopy

Bronchoscopies are performed at t=0 (for instillation of LPS and Drotrecogin alpha) and at t=6 (for performing a bronchoalveolar lavage)

Intervention Type PROCEDURE

Blood sampling

Blood sampling is done by venapuncture at t=0 and t=6

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes