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CompletedNCT04926428Updated Jun 21, 2021

In Situ Thrombolysis With tPA and Inflow Perfusion Analysis in Patient With Severe Covid-19 Infection

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

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Dec 2020, registered Jun 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
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Study summary

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.

Read the detailed description

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

  1. EXTEM and INTEM Hypercoagulable states represented by a maximum amplitude (A5, A10 and MCF) greater than 70mm, short clot formation time.
  2. Hyperfibrinogenemia A5 A10 MCF in FIBTEM greater than 30mm
  3. Absence of fibrinolytic activity (ML% Lys 30 and Lys 60) 100% Taking this into account plus the large number of publications regarding the thrombotic phenomenon of the patient with COVID-19, this could be explained by the presence of a phenomenon of ventilation perfusion (V / Q) that is observed in patients with Massive Pulmonary Thromboembolism (PE) which is known as the infinite relationship, that is, the lung is with normal aeration, but no perfusion, there is no adequate gas exchange, with presence of hypoxia, increment of death space and ultimately obstructive shock.

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.

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Conditions studied

  • COVID-19

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Keywords

  • Covid-19
  • Acute Respiratory Distress Syndrome
  • Thrombosis
03

In context

COVID-19

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 →

Lead sponsor

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.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    experimental arm

    In situ thrombolysis with tPA

    Drug: tPA

Interventions

  • DrugtPA

    Selectively catheter thrombolysis with alteplase in each main pulmonary

    Also known as: in situ thrombolysis

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What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Coagulation

    changes in D Dimer, standard coagulation test and fibrinogen

    Time frame: 48 hours

  2. Oxygenation Index

    changes in PaO2/FiO2 index pre and post-thrombolysis

    Time frame: 48 hours

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Study locations

1 site
  • Hospital General de Mexico Dr Eduardo Liceaga
    Mexico City, 06720, Mexico
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References and documents

Publications

  • Greene R. Pulmonary vascular obstruction in the adult respiratory distress syndrome. J Thorac Imaging. 1986 Jul;1(3):31-8. doi: 10.1097/00005382-198607000-00006. PubMed 3298679 ↗
  • Yao XH, Li TY, He ZC, Ping YF, Liu HW, Yu SC, Mou HM, Wang LH, Zhang HR, Fu WJ, Luo T, Liu F, Guo QN, Chen C, Xiao HL, Guo HT, Lin S, Xiang DF, Shi Y, Pan GQ, Li QR, Huang X, Cui Y, Liu XZ, Tang W, Pan PF, Huang XQ, Ding YQ, Bian XW. [A pathological report of three COVID-19 cases by minimal invasive autopsies]. Zhonghua Bing Li Xue Za Zhi. 2020 May 8;49(5):411-417. doi: 10.3760/cma.j.cn112151-20200312-00193. Chinese. PubMed 32172546 ↗
  • Livingston E, Bucher K. Coronavirus Disease 2019 (COVID-19) in Italy. JAMA. 2020 Apr 14;323(14):1335. doi: 10.1001/jama.2020.4344. No abstract available. PubMed 32181795 ↗
  • Vesconi S, Rossi GP, Pesenti A, Fumagalli R, Gattinoni L. Pulmonary microthrombosis in severe adult respiratory distress syndrome. Crit Care Med. 1988 Feb;16(2):111-3. doi: 10.1097/00003246-198802000-00002. PubMed 3342622 ↗
  • Ospina-Tascon GA, Bautista DF, Madrinan HJ, Valencia JD, Bermudez WF, Quinones E, Calderon-Tapia LE, Hernandez G, Bruhn A, De Backer D. Microcirculatory dysfunction and dead-space ventilation in early ARDS: a hypothesis-generating observational study. Ann Intensive Care. 2020 Mar 24;10(1):35. doi: 10.1186/s13613-020-00651-1. PubMed 32211957 ↗

Individual participant data

Plan to share: Yes — IPD will be shared by petition.

Supporting information: Study protocol, Sap, Icf, Csr

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04926428
Lead sponsor
Grupo Mexicano para el Estudio de la Medicina Intensiva
Responsible party
Sponsor
First posted
Jun 15, 2021
Start date
Dec 25, 2020
Primary completion
Mar 30, 2021
Completion
Mar 30, 2021
Last update
Jun 21, 2021

Study contacts

Jose Damian Carrillo Ruiz, PhD
study director · Hospital General de Mexico Dr. Eduardo Liceaga

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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