Cerebral Bleeding in COVID-19 ARDS Patients on Veno-venous ECMO

NCT04853953 | Unknown

• 1 other identifier: SD03
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

Critically ill patients with severe acute respiratory distress syndrome (ARDS) sometimes require treatment with veno-venous extracorporeal membrane oxygenation (ECMO) to support gas exchange. To prevent clotting of the ECMO circuit, these patients need to be anticoagulated. This protective anticoagulation also leeds to an increased bleeding risk. Most critically ill COVID-19 patients suffer from an ARDS and some require ECMO support. However, the optimal strategy and targets for the anticoagulation of these patients remain uncertain. Studies have shown that COVID-19 is associated with endotheliopathy probably leading to procoagulatory effects. On the other hand, the incidence of bleeding complications associated with this endotheliopathy is not clear and remains to be elucidated. Anticoagulation of COVID-19 patients on ECMO thus poses a challenge for clinicians. The hypothesis of the current project is that COVID-19 patients with ARDS on ECMO exhibit a higher number of bleeding complications compared to historical control patients with non-COVID-19 ARDS requiring ECMO support.

Conditions

Acute Respiratory Distress Syndrome; Extracorporeal Membrane Oxygenation Complication; Corona Virus Infection

Outcome Measures

Primary Outcomes (1)

• Cerebral bleedings in critically ill ARDS patients requiring ECMO support

  Cerebral bleedings will be analyzed and classified according to cerebral imaging (computed tomography, magnetic resonance tomography)

  From date of inclusion of patients into the study, all outcome measures will be analyzed in a time-to-event analysis ranging from ICU admission up to the bleeding event, assessed up to six months

Secondary Outcomes (1)

• Non-cerebral bleedings in critically ill ARDS patients requiring ECMO support

  From date of inclusion of patients into the study, all outcome measures will be analyzed in a time-to-event analysis ranging from ICU admission up to the bleeding event, assessed up to six months

Study Arms (2)

COVID-19 ARDS patients requiring veno-venous ECMO support

Critically ill COVID-19 patients with ARDS requiring ECMO support will be analyzed in this group. Patients from all three study sites will be assessed for participation.

Other: Incidence of bleeding complications in ARDS patients on veno-venous ECMO

Non-COVID-19 ARDS patients requiring veno-venous ECMO support

Critically ill Non-COVID-19 patients with ARDS requiring ECMO support will be analyzed in this group. Patients from all three study sites will be assessed for participation.

Other: Incidence of bleeding complications in ARDS patients on veno-venous ECMO

Interventions

Incidence of bleeding complications in ARDS patients on veno-venous ECMO OTHER

All bleeding complications (especially cerebral bleedings) will be analyzed in the study groups. At the bleeding event, laboratory parameters of coagulation will be collected and the intensity of the ECMO treatment

COVID-19 ARDS patients requiring veno-venous ECMO support; Non-COVID-19 ARDS patients requiring veno-venous ECMO support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of critically ill COVID-19 and Non-COVID-19 ARDS patients requiring veno-venous ECMO support.

You may qualify if:

• Critically ill patients with ARDS requiring ECMO support from all three study sites
• age \> 18 years

You may not qualify if:

• \- Presence of an objective, declared denial to participate

Sponsors & Collaborators

• University of Zurich: lead
• Hannover Medical School: collaborator
• University Hospital, Bonn: collaborator

Related Publications (4)

• Makdisi G, Wang IW. Extra Corporeal Membrane Oxygenation (ECMO) review of a lifesaving technology. J Thorac Dis. 2015 Jul;7(7):E166-76. doi: 10.3978/j.issn.2072-1439.2015.07.17.

  PMID: 26380745 RESULT

• Rawal G, Yadav S, Kumar R. Acute Respiratory Distress Syndrome: An Update and Review. J Transl Int Med. 2018 Jun 26;6(2):74-77. doi: 10.1515/jtim-2016-0012. eCollection 2018 Jun.

  PMID: 29984201 RESULT

• Varga Z, Flammer AJ, Steiger P, Haberecker M, Andermatt R, Zinkernagel AS, Mehra MR, Schuepbach RA, Ruschitzka F, Moch H. Endothelial cell infection and endotheliitis in COVID-19. Lancet. 2020 May 2;395(10234):1417-1418. doi: 10.1016/S0140-6736(20)30937-5. Epub 2020 Apr 21. No abstract available.

  PMID: 32325026 RESULT

• Seeliger B, Doebler M, Hofmaenner DA, Wendel-Garcia PD, Schuepbach RA, Schmidt JJ, Welte T, Hoeper MM, Gillmann HJ, Kuehn C, Ehrentraut SF, Schewe JC, Putensen C, Stahl K, Bode C, David S. Intracranial Hemorrhages on Extracorporeal Membrane Oxygenation: Differences Between COVID-19 and Other Viral Acute Respiratory Distress Syndrome. Crit Care Med. 2022 Jun 1;50(6):e526-e538. doi: 10.1097/CCM.0000000000005441. Epub 2022 Jan 12.

  PMID: 35020672 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; Coronavirus Infections

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Sascha David, Prof

  University Hospital Zurich, Institute of Intensive Care

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sascha David, Prof

CONTACT

0041442552204; Sascha.david@usz.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 22, 2021
• Study Start: April 30, 2021
• Primary Completion: July 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 22, 2021

Record last verified: 2021-04