An interventional study of tPA in COVID-19, sponsored by Grupo Mexicano para el Estudio de la Medicina Intensiva. Completed at 1 site in Mexico. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-06-21.
Sponsored by Grupo Mexicano para el Estudio de la Medicina Intensiva · Not applicable, Interventional, and Diagnostic
To estimate the pulmonary response microvascular thrombosis in critical patients due to SARS-Cov-2., at the Hospital General de México "Dr. Eduardo Liceaga", a 15 patients compassionate treatment study was authorized and approved by the ethics and research committee DI-222-2020. Because of the severity of the illness the legal representative sign informed consent in all the patients for performing in-situ thrombolysis with alteplase selectively by catheter in each main pulmonary artery, under fluoroscopic guidance and acquiring images with the iFlow software to assess immediate and post-procedure response.
The main clinical characteristic of patients with severe SARS-Cov-2 infection is hypoxemic respiratory failure that requires Mechanical Ventilation. The Acute Respiratory Syndrome model has been proposed as the cause of this significant deterioration in lung function and all management has focused on ventilatory support management. As for ventilatory failure, it has been attributed to the presence of severe pulmonary inflammation evolving to fibrosis, which is the clinical characteristic of patients with Primary Respiratory Distress Syndrome (which would be the case of this as it is considered a respiratory virus).
Several autopsy studies demonstrated microthrombi in pulmonary circulation. The major limitation of these investigations is that the autopsy provided static information. Some of these alterations could be secondary to the disseminated intravascular coagulation (DIC) observed as the standard route to the multisystem organ failure exhibited in critically ill patients.
With this comes the contradictory results of high doses of anticoagulants in the survival of these patients. This intermediate to high doses can reduce organ support treatments in moderate cases, however, in critically ill patients the benefit of high dose of anticoagulants, once again failed to produce benefit on survival. Different publication on biopsies made in these patients have report the presence of thrombosis in the microcirculation and finally recently has been published the demonstration by direct examination with Citoscam, the presence of this thrombosis of the microcirculation in vivo in 11 of 13 test (85% of the sample). Studies performed with viscoelastic coagulation tests present evidence of three key alterations in coagulation
In patients with COVID-19, this phenomenon is observed in patients with absence of massive or submassive PE that explains this phenomenon.
The high mortality of critically ill patients with SARS-Cov-2 infection, the presence of thrombosis of the microcirculation and the lack of efficacy of anticoagulation in some cases suggests that this phenomenon could be the cause of the behavior between perfusion ventilation observed in SARS-Cov-2 patients.
For these reasons, a probe of concept research was developed to find out if pulmonary perfusion alteration by microthrombosis and secondary V / Q abnormalities could be linked to the pathophysiology of the patient with severe SARS-Cov-2 infection.
To estimate the pulmonary response microvascular thrombosis in critical patients due to SARS-Cov-2., at the Hospital General de México "Dr. Eduardo Liceaga", a 15 patients compassionate treatment study was authorized and approved by the ethics and research committee DI-222-2020. Because of the severity of the illness the legal representative sign informed consent in all the patients for performing in-situ thrombolysis with alteplase selectively by catheter in each main pulmonary artery, under fluoroscopic guidance and acquiring images with the iFlow software to assess immediate and post-procedure response.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 15 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Grupo Mexicano para el Estudio de la Medicina Intensiva is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:Lung criteria:
Patients with severe Covid 19 nfection, from 18 to 75 years old, Invasive Mechanical Ventilation (IMV) Pao2 / fio2 less than 150 Non réponse to prone position Coagulation criteria ISTH score >5, D-dimer greater than 1200, Viscoelastic testing EXTEM A5 >65 FIBTEM > 30 and EXTEM ML\<8%
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Exclusion Criteria:
Ischemic CVD or presence of abnormal neurological examination. Active bleeding. Acute Myocardial Infarction within the previous three weeks or cardiac arrest during hospitalization.
cardiac tamponade. endocarditis. uncontrolled hypertension SBP> 185mmhg or DBP> 110. history of stage 4 cancer. history of brain tumor. Arterious venous malformation ruptured aneurysm. major surgery in the previous 2 weeks major trauma in the previous 2 weeks. pregnancy. fibrinogen less than 200 blood dyscrasias thrombocytopenia less than 30,000
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In situ thrombolysis with tPA
Drug: tPA
Selectively catheter thrombolysis with alteplase in each main pulmonary
Also known as: in situ thrombolysis
Changes in lung perfusion
changes in contrast distribution comparing pre and post-thrombolysis using Iflow parameters that include ROI, peak flow and Time
Time frame: 1 hour
Coagulation
changes in D Dimer, standard coagulation test and fibrinogen
Time frame: 48 hours
Oxygenation Index
changes in PaO2/FiO2 index pre and post-thrombolysis
Time frame: 48 hours
Plan to share: Yes — IPD will be shared by petition.
Supporting information: Study protocol, Sap, Icf, Csr
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Grupo Mexicano para el Estudio de la Medicina Intensiva