Cardiac ArrestSEACNCT01298050
Refractory IHCA and OHCA Treated With ECMO
An observational study of Cardiac Arrest, run by University of Milano Bicocca at 1 site in Italy.
Trial summary
Extracorporeal membrane oxygenation (ECMO) support has been suggested to improve the survival rate in patients with refractory cardiac arrest (CA). Recent studies have also highlighted the potential early application of this method in improving the prognosis of prolonged cardiac arrest both for in hospital CA (INHCA)… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- ECMO
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2011to Jul 2013
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults 18-75 years old, community sample
Who may be able to join
- Adults 18-75 years old
- In and out of hospital Witnessed Cardiac Arrest
- No-flow time < 5 min. or VF,VT,TP as rhythm of presentation
- Low-flow time < 45 min.
- End Tidal CO2 > 10 after 20 min.of CPR
Who cannot join
- Comorbidities such:
- Terminal Malignancy
- Aortic Dissection
- Severe Cardiac Failure without transplant indication
- Severe Aortic Valve Failure
- Known Severe Peripheral arteriopathy
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
San Gerardo Hospital
Monza, MB, 20052
Leonello Avalli, MD, 0039392334330, l.avalli@hsgerardo.org
Roberto Fumagalli, MD, 0039392339294, r.fumagalli@hsgerardo.org
About this study
Official title: Refractory In and Out of Hospital Cardiac Arrest Treated With Extracorporeal Membrane Oxygenation. Observational, Single Centre, Prospective Study.
Extracorporeal membrane oxygenation (ECMO) support has been suggested to improve the survival rate in patients with refractory cardiac arrest (CA). Recent studies have also highlighted the potential early application of this method in improving the prognosis of prolonged cardiac arrest both for in hospital CA (INHCA) and out of hospital CA (OHCA). The rationale for use of ECMO in these patients is to optimize early perfusion of vital organs, curing the cause of CA and waiting for the recovery of the injured myocardium. The investigators have created a flow-chart to decide which patients are eligible. The aims of this study are to evaluate if, with this flow-chart, the investigators are able to detect which patients have more probability of survival.
- Conditions
- Cardiac Arrest
- Being tested
- ECMO
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECMOProcedure or surgery
Insertion of peripheral Veno-Arterious ECMO, subsequent therapeutic hypothermia
| Study group | Role | What they receive |
|---|---|---|
| Extracorporeal Membrane Oxygenation | All patients have to start ECMO under CPR, by insertion of peripheral VA cannulas. Receives: Procedure: ECMO |
What is being measured
The primary outcome is the main question the study is designed to answer.
28 days survival
Measured: 28 days
Secondary outcomes (3)
Neurologic recovery
Neurologic recovery defined as minimal neurologic impairment according to the Glasgow-Pittsburgh cerebral performance categories score ≤ 2.
Measured: 28 days
Cardiac recovery
Measured by echocardiography
Measured: 28 days
Six months survival with minimal neurologic impairment
survival with minimal neurologic impairment according to the Glasgow-Pittsburgh cerebral performance categories score ≤ 2.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2012 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Collaborators
- Ospedale San Gerardo. S.S.U.E.M. 118 Brianza, Ospedale San Gerardo. Terapia Intensiva Cardiochirurgica
- Investigators
- Leonelllo Avalli, MD, Principal investigator, Ospedale San Gerardo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01298050
- Sponsor's protocol ID
- AOSG-TICCH-01-2011
- Acronym
- SEAC
- Status last verified
- Jul 2011
- First submitted
- 16 Feb 2011
- Last updated
- 4 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refractory In and Out of Hospital Cardiac Arrest Treated With Extracorporeal Membrane Oxygenation. Observational, Single Centre, Prospective Study.
- ClinicalTrials.gov ID
- NCT01298050
- Acronym / sponsor ID
- SEAC / AOSG-TICCH-01-2011
- Conditions
- Cardiac Arrest
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Collaborators
- Ospedale San Gerardo. S.S.U.E.M. 118 Brianza, Ospedale San Gerardo. Terapia Intensiva Cardiochirurgica
- Study start
- Jul 2011
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 17 Feb 2011 (estimated)
- 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.
Extracorporeal membrane oxygenation (ECMO) support has been suggested to improve the survival rate in patients with refractory cardiac arrest (CA). Recent studies have also highlighted the potential early application of this method in improving the prognosis of prolonged cardiac arrest both for in hospital CA (INHCA) and out of hospital CA (OHCA). The rationale for use of ECMO in these patients is to optimize early perfusion of vital organs, curing the cause of CA and waiting for the recovery of the injured myocardium. The investigators have created a flow-chart to decide which patients are eligible. The aims of this study are to evaluate if, with this flow-chart, the investigators are able to detect which patients have more probability of survival.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal Membrane Oxygenation | – | Procedure: ECMOAll patients have to start ECMO under CPR, by insertion of peripheral VA cannulas. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults 18-75 years old, community sample
Key inclusion criteria (5 listed)
- Adults 18-75 years old
- In and out of hospital Witnessed Cardiac Arrest
- No-flow time < 5 min. or VF,VT,TP as rhythm of presentation
- Low-flow time < 45 min.
- End Tidal CO2 > 10 after 20 min.of CPR
Key exclusion criteria (6 listed)
- Comorbidities such:
- Terminal Malignancy
- Aortic Dissection
- Severe Cardiac Failure without transplant indication
- Severe Aortic Valve Failure
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 |
|---|---|---|
| ECMOInsertion of peripheral Veno-Arterious ECMO, subsequent therapeutic hypothermia | Procedure or surgery | Extracorporeal Membrane Oxygenation |
Primary outcome
28 days survival
Time frame: 28 days
3 secondary outcomes
Neurologic recovery
Time frame: 28 days
Cardiac recovery
Time frame: 28 days
Six months survival with minimal neurologic impairment
Time frame: 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2011.
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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.
Leonelllo Avalli, MD principal investigator
Ospedale San Gerardo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest, run by University of Milano Bicocca at 1 site in Italy.
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 5 inclusion and 6 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 4 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28 days survival (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2011.