Study Stopped
Per recommendation of the NHLBI DSMB
Activated Protein C to Treat Acute Lung Injuries
Prospective, Randomized Phase II Clinical Trial of Activated Protein C (Xigris) Versus Placebo for the Treatment of Acute Lung Injury
2 other identifiers
interventional
90
1 country
9
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2005
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 27, 2005
CompletedFirst Posted
Study publicly available on registry
May 30, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedMarch 13, 2014
March 1, 2014
May 27, 2005
March 11, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of ventilator-free days (measured at Day 28)
Interventions
Eligibility Criteria
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
- 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
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
University of California San Francisco at Fresno
Fresno, California, 93702, United States
University of Southern California
Los Angeles, California, 97239-3098, United States
San Francisco General Hospital
San Francisco, California, 94110, United States
University of California San Francisco
San Francisco, California, 94143-0130, United States
Stanford University, Department of Pulmonary and Critical Care
Stanford, California, 94305, United States
Yale School of Medicine, Section of Pulmonary & Critical Care Medicine
New Haven, Connecticut, 06520-8057, United States
Joseph M. Still Burn Center
Augusta, Georgia, 97239-3098, United States
Bay State Medical Center
Springfield, Massachusetts, 01199, United States
Oregon Health Sciences University
Portland, Oregon, 97239-3098, United States
Related Publications (5)
Ware LB, Matthay MA. The acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1334-49. doi: 10.1056/NEJM200005043421806. No abstract available.
PMID: 10793167BACKGROUNDBernard GR, Vincent JL, Laterre PF, LaRosa SP, Dhainaut JF, Lopez-Rodriguez A, Steingrub JS, Garber GE, Helterbrand JD, Ely EW, Fisher CJ Jr; Recombinant human protein C Worldwide Evaluation in Severe Sepsis (PROWESS) study group. Efficacy and safety of recombinant human activated protein C for severe sepsis. N Engl J Med. 2001 Mar 8;344(10):699-709. doi: 10.1056/NEJM200103083441001.
PMID: 11236773BACKGROUNDNuckton TJ, Alonso JA, Kallet RH, Daniel BM, Pittet JF, Eisner MD, Matthay MA. Pulmonary dead-space fraction as a risk factor for death in the acute respiratory distress syndrome. N Engl J Med. 2002 Apr 25;346(17):1281-6. doi: 10.1056/NEJMoa012835.
PMID: 11973365BACKGROUNDAcute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
PMID: 10793162BACKGROUNDLiu KD, Levitt J, Zhuo H, Kallet RH, Brady S, Steingrub J, Tidswell M, Siegel MD, Soto G, Peterson MW, Chesnutt MS, Phillips C, Weinacker A, Thompson BT, Eisner MD, Matthay MA. Randomized clinical trial of activated protein C for the treatment of acute lung injury. Am J Respir Crit Care Med. 2008 Sep 15;178(6):618-23. doi: 10.1164/rccm.200803-419OC. Epub 2008 Jun 19.
PMID: 18565951DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Michael Matthay
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 27, 2005
First Posted
May 30, 2005
Study Start
January 1, 2005
Study Completion
February 1, 2007
Last Updated
March 13, 2014
Record last verified: 2014-03