Acute Respiratory Distress SyndromeNCT04853953
Cerebral Bleeding in COVID-19 ARDS Patients on Veno-venous ECMO
An observational study of Acute Respiratory Distress Syndrome and Extracorporeal Membrane Oxygenation Complication, run by University of Zurich.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Extracorporeal Membrane Oxygenation Complication, Corona Virus Infection
- What is being tested?
- Incidence of bleeding complications in ARDS patients on veno-venous ECMO
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2021to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of critically ill COVID-19 and Non-COVID-19 ARDS patients requiring veno-venous ECMO support.
Who may be able to join
- Critically ill patients with ARDS requiring ECMO support from all three study sites
- age > 18 years
Who cannot join
- Presence of an objective, declared denial to participate
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Incidence of Bleeding Complications in Critically Ill COVID-19 Patients With Acute Respiratory Distress Syndrome on Veno-venous ECMO
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.
Read more
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.
Read the detailed description
The primary aim of the project is to retrospectively analyze the incidence of bleeding complications (especially cerebral bleedings) in critically ill COVID-19 patients with ARDS requiring ECMO support. The incidences of bleeding will be compared with a historical control cohort of non-COVID-19 patients on ECMO support.
The data analysis will be set up within a multicentric, retrospective study involving the University Hospital Zurich (Switzerland), the Medical School Hannover (Germany) and the University Hospital Bonn (Germany). The aim of the multicentric approach is to increase the case load and to improve the validity of the data, which could possibly have therapeutic implications in the future.
Aside from demographic and baseline date, mortality and causes of death, comorbidities, the anticoagulation strategy (substance, targets of anticoagulation) and laboratory parameters of the anticoagulation during the bleeding events will be collected.
Furthermore, the intensity of the ECMO treatment (blood flow, sweep gas flow, oxygen requirement) during the bleeding events and the catecholamine use during ECMO implantation will be analyzed.
To enhance comparability, intensive care specific treatments (proning, sedation and analgesia, COVID-19 targeted therapy) will be collected and analyzed.
- Conditions
- Acute Respiratory Distress Syndrome, Extracorporeal Membrane Oxygenation Complication, Corona Virus Infection
- Being tested
- Incidence of bleeding complications in ARDS patients on veno-venous ECMO
- Medical subject headings
- Respiratory Distress Syndrome, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incidence of bleeding complications in ARDS patients on veno-venous ECMOOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Incidence of bleeding complications in ARDS patients on veno-venous ECMO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Bleedings will be classified according to the documentation in the electronic medical reports
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start30 Apr 2021 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Hannover Medical School, University Hospital, Bonn
- Responsible party
- Sponsor
- Investigators
- Sascha David, Prof, Principal investigator, University Hospital Zurich, Institute of Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04853953
- Sponsor's protocol ID
- SD03
- Status last verified
- Apr 2021
- First submitted
- 16 Apr 2021
- Last updated
- 22 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26380745Rawal 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.
PubMed 29984201Varga 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.
PubMed 32325026Seeliger 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.
PubMed 35020672
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Bleeding Complications in Critically Ill COVID-19 Patients With Acute Respiratory Distress Syndrome on Veno-venous ECMO
- ClinicalTrials.gov ID
- NCT04853953
- Acronym / sponsor ID
- SD03
- Conditions
- Acute Respiratory Distress Syndrome, Extracorporeal Membrane Oxygenation Complication, Corona Virus Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Hannover Medical School, University Hospital, Bonn
- Study start
- 30 Apr 2021 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary aim of the project is to retrospectively analyze the incidence of bleeding complications (especially cerebral bleedings) in critically ill COVID-19 patients with ARDS requiring ECMO support. The incidences of bleeding will be compared with a historical control cohort of non-COVID-19 patients on ECMO support.
The data analysis will be set up within a multicentric, retrospective study involving the University Hospital Zurich (Switzerland), the Medical School Hannover (Germany) and the University Hospital Bonn (Germany). The aim of the multicentric approach is to increase the case load and to improve the validity of the data, which could possibly have therapeutic implications in the future.
Aside from demographic and baseline date, mortality and causes of death, comorbidities, the anticoagulation strategy (substance, targets of anticoagulation) and laboratory parameters of the anticoagulation during the bleeding events will be collected.
Furthermore, the intensity of the ECMO treatment (blood flow, sweep gas flow, oxygen requirement) during the bleeding events and the catecholamine use during ECMO implantation will be analyzed.
To enhance comparability, intensive care specific treatments (proning, sedation and analgesia, COVID-19 targeted therapy) will be collected and analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 ARDS patients requiring veno-venous ECMO support | – | Other: Incidence of bleeding complications in ARDS patients on veno-venous ECMOCritically 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. |
| Non-COVID-19 ARDS patients requiring veno-venous ECMO support | – | Other: Incidence of bleeding complications in ARDS patients on veno-venous ECMOCritically 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of critically ill COVID-19 and Non-COVID-19 ARDS patients requiring veno-venous ECMO support.
Key inclusion criteria (2 listed)
- Critically ill patients with ARDS requiring ECMO support from all three study sites
- age > 18 years
Key exclusion criteria (1 listed)
- Presence of an objective, declared denial to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Incidence of bleeding complications in ARDS patients on veno-venous ECMOAll 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 | Other | COVID-19 ARDS patients requiring veno-venous ECMO support, Non-COVID-19 ARDS patients requiring veno-venous ECMO support |
Primary outcome
Cerebral bleedings in critically ill ARDS patients requiring ECMO support
Time frame: 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
Cerebral bleedings will be analyzed and classified according to cerebral imaging (computed tomography, magnetic resonance tomography)
1 secondary outcome
Non-cerebral bleedings in critically ill ARDS patients requiring ECMO support
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2021.
- Results publication: PubMed 26380745Makdisi 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.
- Results publication: PubMed 29984201Rawal 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.
- Results publication: PubMed 32325026Varga 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.
- Derived from this study: PubMed 35020672Seeliger 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sascha David, Prof principal investigator
University Hospital Zurich, Institute of Intensive Care
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome and Extracorporeal Membrane Oxygenation Complication, run by University of Zurich.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sascha David, Prof (0041442552204, Sascha.david@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral bleedings in critically ill ARDS patients requiring ECMO support (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04853953, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2021.