Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-31 @ 4:03 AM
Study NCT ID:
NCT02809703
Status:
WITHDRAWN
Last Update Posted:
2019-11-22
First Post:
2016-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life Following ECMO
Sponsor:
Duke University
Organization:
Study Overview
Official Title:
Assessment of the Long Term Quality of Life Following Veno-venous and Veno-arterial Extracorporeal Membrane Oxygenation (ECMO)
Status:
WITHDRAWN
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI departed study site. Study closed.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of the study is to determine the quality of life of patients in the years following treatment with extracorporeal membrane oxygenation (ECMO). The study population will include all adults treated with any configuration of ECMO at Duke University Medical Center during the period of Jan 1, 2009 and Dec 31, 2015. Patient's will be contacted by direct mail, in conjunction with a surgeon who performed their ECMO procedure or managed them while on ECMO, and asked to complete a validated survey (WHOQOL-Bref) which assesses quality of life. In addition, patients will be asked to opt-in to participate in a phone survey in which they can give a narrative about their ICU experience and answer specific questions regarding long-term comorbidities. Data will be stored in a secure online server which is HIPAA compliant and analyzed by the department of anesthesiology statistical support services. De-identified data will be shared with the WHO as specified in their usage agreement.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: