Status:
TERMINATED
Activated Protein C to Treat Acute Lung Injuries
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Respiratory Distress Syndrome, Adult
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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).
Detailed Description
BACKGROUND: The hypothesis that procoagulant and inflammatory mechanisms may have a dual role in tissue injury was tested in the phase III clinical trial of recombinant Xigris for severe sepsis (Bern...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Known bleeding diathesis
- Concurrent therapeutic heparin (greater than 14 units/kg/hr)
- Platelet count less than 30,000 x 106/L, even if the platelet count is increased after transfusions
- Prothrombin time greater than 3.0 INR
- Gastrointestinal bleeding within 6 weeks of study entry
- Concurrent need for systemic anticoagulation with therapeutic unfractionated heparin or low molecular weight heparin during the study drug infusion
- Concurrent administration of an anticoagulant (other than subcutaneous heparin for prophylaxis)
- Concurrent need for platelet glycoprotein Iib/IIIa antagonists or any other antiplatelet agents (patients taking aspirin or other antiplatelet agents at study entry are eligible if medication can be discontinued during study drug infusion)
- Surgery within 30 days of study entry and single organ failure
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2007
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00112164
Start Date
January 1 2005
End Date
February 1 2007
Last Update
March 13 2014
Active Locations (9)
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1
University of California San Francisco at Fresno
Fresno, California, United States, 93702
2
University of Southern California
Los Angeles, California, United States, 97239-3098
3
San Francisco General Hospital
San Francisco, California, United States, 94110
4
University of California San Francisco
San Francisco, California, United States, 94143-0130