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

NCT04926428 | Completed

• 1 other identifier: DI-222-2020
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19

Keywords

Covid-19; Acute Respiratory Distress Syndrome; Thrombosis

Outcome Measures

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

  1 hour

Secondary Outcomes (2)

• Coagulation

  48 hours

• Oxygenation Index

  48 hours

Study Arms (1)

experimental arm

EXPERIMENTAL

In situ thrombolysis with tPA

Drug: tPA

Interventions

tPA DRUG

Selectively catheter thrombolysis with alteplase in each main pulmonary

Also known as: in situ thrombolysis

experimental arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Grupo Mexicano para el Estudio de la Medicina Intensiva: lead

Study Sites (1)

Hospital General de Mexico Dr Eduardo Liceaga

Mexico City, 06720, Mexico

Location

Related Publications (5)

• 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.

  PMID: 3298679 BACKGROUND

• 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.

  PMID: 32172546 BACKGROUND

• 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.

  PMID: 32181795 BACKGROUND

• 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.

  PMID: 3342622 BACKGROUND

• 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.

  PMID: 32211957 BACKGROUND

MeSH Terms

Conditions

COVID-19; Respiratory Distress Syndrome; Thrombosis

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jose Damian Carrillo Ruiz, PhD

  Hospital General de Mexico Dr. Eduardo Liceaga

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2021
• First Posted: June 15, 2021
• Study Start: December 25, 2020
• Primary Completion: March 30, 2021
• Study Completion: March 30, 2021
• Last Updated: June 21, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 3 months up to 5 years after completion
• Access Criteria: proposal should be directed to gmemiinv@gmails.com, to gain access, requestor will need to sign a data access agreement

Locations

ME (1)