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Outcomes of Patients With Venoarterial Extracorporeal Membrane Oxygenation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04039594
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Xiaotong Hou, Beijing Anzhen Hospital

Brief Summary:
Venoarterial extracorporeal membrane oxygenation (VA ECMO)—also referred to as extracorporeal life support—is a form of temporary mechanical circulatory support and simultaneous extracorporeal gas exchange. The objective of this observational, cohort study is to evaluate the short-term and long-term outcomes of patients with VA ECMO.

Condition or disease Intervention/treatment
Cardiogenic Shock Cardiac Arrest Device: VA ECMO

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Outcomes of Patients With Venoarterial Extracorporeal Membrane Oxygenation
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : July 31, 2024
Estimated Study Completion Date : July 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Group/Cohort Intervention/treatment
ECMO Device: VA ECMO
VA ECMO for cardiopulmonary support




Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: 365 days ]
  2. Rate of successful weaning from ECMO [ Time Frame: 30 days ]
  3. ECMO-related complications [ Time Frame: 30 days ]
    Bleeding requiring transfusion or surgery, stroke, sepsis, limb ischemia requiring intervention, system or cannula change

  4. Other complications [ Time Frame: 30 days ]
    Acute renal failure, ulcer bleeding, pneumonia, sepsis

  5. Duration stay at ICU and hospital [ Time Frame: 365 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients receiving VA ECMO for cardiopulmonary support
Criteria

Inclusion Criteria:

Patients receiving VA ECMO for cardiopulmonary support

Exclusion Criteria:

Refusal of consent


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04039594


Contacts
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Contact: Xiaotong Hou, MD., PhD. 8610 64456631 xt.hou@ccmu.edu.cn

Locations
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China, Beijing
Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100029
Contact: Xiaotong Hou, MD., PhD.    8610 64456631    xt.hou@ccmu.edu.cn   
Principal Investigator: Xiaotong Hou, MD., PhD.         
Sponsors and Collaborators
Beijing Anzhen Hospital
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Responsible Party: Xiaotong Hou, Chief, Center for Cardiac Intensive Care, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier: NCT04039594    
Other Study ID Numbers: 2019027X
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiaotong Hou, Beijing Anzhen Hospital:
extracorporeal life support, extracorporeal membrane oxygenation, cardiogenic shock, cardiac arrest
Additional relevant MeSH terms:
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Heart Arrest
Shock, Cardiogenic
Shock
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Myocardial Infarction
Myocardial Ischemia
Vascular Diseases