Activated Protein C to Treat Acute Lung Injuries

Stopped early · Phase 2

Conditions studied: Respiratory Distress Syndrome, Adult

In brief

The purpose of this study is to test the efficacy of activated Protein C (Xigris) for improving clinical outcomes in individuals with acute lung injury (ALI).

Key facts

Study ID

NCT00112164

Run by

University of California, San Francisco

People needed

90

Starts

2005-01-01

Expected to finish

2007-02-01

Last updated by the study team

2014-03-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• PaO2/FiO2 levels less than or equal to 300
• Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph
• Positive pressure ventilation through an endotracheal tube or tracheostomy
• No clinical evidence of left atrial hypertension that would explain the pulmonary infiltrates; if measured, pulmonary arterial wedge pressure less than or equal to 18 mm Hg

You may not qualify if…

• Family / patient refuses
• Patient / surrogate unavailable
• Attending refuses
• Age younger than 18 years
• Severe sepsis and Acute Physiology and Chronic Health Evaluation (APACHE) II scores greater than 25 within 48 hours of onset of severe sepsis
• Greater than 72 hours since all inclusion criteria are met
• Neuromuscular disease that impairs ability to ventilate without assistance, such as C5 or higher spinal cord injury, amyotrophic lateral sclerosis, Guillain-Barré syndrome, myasthenia gravis, or kyphoscoliosis
• Pregnant
• Severe chronic respiratory disease
• Weighs more than 160 kg
• Burns to more than 70% of total body surface area
• Cancer or other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%
• Bone marrow transplant in the 5 years prior to study entry
• Not committed to full support
• Severe chronic liver disease, as determined by a Child-Pugh Score of 11 to 15
• Diffuse alveolar hemorrhage from vasculitis
• Participation in another experimental medication study within 30 days of study entry
• Patients who have already received APC therapy
• Active internal bleeding
• Hemorrhagic or ischemic stroke within 3 months of study entry
• Intracranial or intraspinal surgery or severe head trauma within 2 months of study entry
• Trauma with an increased risk of life-threatening bleeding
• Presence of an epidural catheter
• Intracranial neoplasm mass lesion or evidence of cerebral herniation
• High risk of intracranial hemorrhage, as determined by 1 of the following: 1) intracranial or spinal pathology which places individuals at risk for intracranial hemorrhage (e.g., arterio-venous malformation or previous intracranial bleeding events, not including meningitis); 2) acute change in neurological status with focal neurological findings; 3) documented intracranial hypertension by lumbar puncture or imaging; or 4) seizures in which there is a clinical suspicion of intracranial hemorrhage

Where it is running

• University of California San Francisco at Fresno — Fresno, California, United States
• University of Southern California — Los Angeles, California, United States
• San Francisco General Hospital — San Francisco, California, United States
• University of California San Francisco — San Francisco, California, United States
• Stanford University, Department of Pulmonary and Critical Care — Stanford, California, United States
• Yale School of Medicine, Section of Pulmonary & Critical Care Medicine — New Haven, Connecticut, United States
• Joseph M. Still Burn Center — Augusta, Georgia, United States
• Bay State Medical Center — Springfield, Massachusetts, United States
• Oregon Health Sciences University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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