NCT02809703

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2016

Completed
1.2 years until next milestone

Study Start

First participant enrolled

August 28, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2018

Completed
Last Updated

November 22, 2019

Status Verified

November 1, 2019

Enrollment Period

9 months

First QC Date

June 20, 2016

Last Update Submit

November 20, 2019

Conditions

Extracorporeal Membrane OxygenationQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Quality of Life as Assessed by the WHOQOL-BREF.

    6 months to 5 years post ECMO procedure

Interventions

Survey QuestionsOTHER

Subjects will receive surveys via direct mail. They will be given the opportunity to opt in to receive a phone call regarding quality of life.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent VV or VA ECMO at Duke.

You may qualify if:

  • VA or VV ECMO performed during retrospective study period

You may not qualify if:

  • Pediatric

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27701, United States

Location
0

Study Design

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

Study Record Dates

First Submitted

June 20, 2016

First Posted

June 22, 2016

Study Start

August 28, 2017

Primary Completion

June 1, 2018

Study Completion

July 18, 2018

Last Updated

November 22, 2019

Record last verified: 2019-11

Locations

US(1)