Status:
WITHDRAWN
Impact of Tissue Plasminogen Activator (tPA) Treatment for an Atypical Acute Respiratory Distress Syndrome (COVID-19)
Lead Sponsor:
Negovsky Reanimatology Research Institute
Collaborating Sponsors:
Demikhov Municipal Clinical Hospital 68
Conditions:
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
At the beginning COVID-associated lung injury was considered as typical ARDS, hence respiratory and nonrespiratory treatments were delivered according to general principles for this kind of illness. T...
Detailed Description
COVID 19 pandemic is a serious challenge for International medical community. There is lack of knowledge about the nature and character of the lung injury caused by this kind of infection. At the begi...
Eligibility Criteria
Inclusion
- Severe pulmonary coronavirus disease 19 (COVID 19) with suspect for MicroCLOTS (microvascular COVID-19 lung vessels obstructive thromboinflammatory syndrome)
- P/F ratio \<200 mmHg\> 70 mmHg
- a.) Contrast CT scan positive for pulmonary thrombosis, OR b.) Contrast CT scan negative for pulmonary thrombosis:
- D-Dimer \> 10 mcg/mL, OR
- 5 \< D-dimer \< 10 mcg/mL and C Reactive Protein (CRP) \> 100 mg/dL
Exclusion
- Age \< 18
- Pregnancy or breastfeeding
- Known allergy to iodinated contrast dye
- Severe vasoplegic shock: norepinephrine \> 300 ng/kg\*min
- Glomerular Filtration rate \< 30 ml/min
- Active bleeding or absolute contraindication to anticoagulant therapy (Stroke (intracranial hemorrhage, hemorrhagic stroke), including a history of the last 6 months.; cancer of the Central nervous system and other localities with an increased risk of bleeding, vascular aneurysm, traumatic open heart massage, obstetric delivery, General operations, severe uncontrolled hypertension, gastric ulcer and 12-duodenal ulcer (for 3 months. from the moment of exacerbation), arterial or venous malformations, liver failure, liver cirrhosis, portal hypertension, esophageal varicose veins, active hepatitis).
Key Trial Info
Start Date :
October 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04453371
Start Date
October 15 2020
End Date
February 15 2021
Last Update
March 12 2021
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