Status:
WITHDRAWN
Treatment of Acute Respiratory Distress Syndrome With Tenecteplase: A Dose Escalation Pilot Study
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The pathogenesis of ARDS appears to be from damage to the alveolar-capillary barrier, which is composed of the microvascular endothelium and the alveolar epithelium. This damage may occur from direct ...
Detailed Description
1. Treatment of acute respiratory distress syndrome with tenecteplase, a dose escalation pilot study: phase I 2. The study sample size will be 20 patients. The 20 patients will be divided into 4 group...
Eligibility Criteria
Inclusion
- Ability to provide written informed consent and comply with study assessments for full duration of the study by family member.
- Patient-related considerations - See exclusion criteria
- Disease-related considerations - ARDS is indicated by respiratory failure of acute onset, bilateral lung infiltrates, PaO2/Fi02 \<200 mmHg,pulmonary artery wedge pressure \< 18 mmHg, and need for a ventilator. (If the wedge pressure is \>18, the patient is excluded from this study).
- Only acute stage ARDS patients will be enrolled in the study. This is defined by patients with ARDS for \<1 week.
- Other considerations
- Satisfactory recruitment and cooperation
- A signed informed consent document
- No participation in another clinical and/or observational trial
- No previous participation in this study
- Not a prisoner or otherwise in custody and not institutionalized for mental incompetence.
- Patients with major trauma will only be included 5 days after trauma has occurred.
Exclusion
- Bleeding - active internal bleeding
- History of cerebrovascular accident
- Intracranial neoplasm, arteriovenous malformation, or aneurysm or acute trauma
- Known bleeding diathesis
- Severe uncontrolled HTN
- Thrombin time over 2 times laboratory normal
- Prothrombin time or partial thromboplastin time \> 2 times normal
- Fibrinogen \<100
- Platelets \<100
- Creatine \>2.0
- Liver function tests \> 2 times normal
- History of coagulopathy, ulcer, or stroke
- Systolic blood pressure \>180, diastolic blood pressure \>110
- History of fibrinolytic use within one month prior to treatment
- History of diabetic retinopathy
- Pregnancy, pregnancy will be ruled out in women of childbearing age by urine test.
- Obstetric delivery or intracranial injury within one month prior to treatment
- Major trauma, major surgery, or CPR within 5 days or minor surgery or minor trauma within 2 days. The classification of major or minor is made by attending physician.
- Patients undergoing non-operative management of liver, spleen, and kidney trauma.
- Aspirin therapy \>650mg q day
- Epidural or spinal catheter within 5 days.
- Known risk for embolization, including history of left heart thrombus, mitral stenosis with atrial fibrillation, acute pericarditis, and subacute bacterial endocarditis.
- Over the age of 75 years
- Patients on Xigris
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00431379
Start Date
February 1 2007
End Date
December 1 2008
Last Update
October 16 2024
Active Locations (1)
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1
Medical Center of Central GA
Macon, Georgia, United States, 31201