NCT02682849

Brief Summary

The purpose of this study is to evaluate the effectiveness of the PleuraFlow® Active Clearance Technology™ (ACT) System in the management of blood evacuation after cardiac surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

February 11, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 15, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

May 10, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

October 29, 2020

Status Verified

October 1, 2020

Enrollment Period

2 years

First QC Date

February 11, 2016

Last Update Submit

October 28, 2020

Conditions

Retained Blood Syndrome

Outcome Measures

Primary Outcomes (1)

  • Number of interventions to Treat Retained Blood Syndrome

    Retained Blood Syndrome (RBS) is defined by a composite endpoint of specific reoperation for bleeding, pericardial effusion, and hemothorax.

    Discharge from operating room for index-surgery through hospital discharge - approximate 30 days

Secondary Outcomes (2)

  • Number of episodes of new on set of post operative atrial fibrillations (POAS)

    30 day

  • Number of readmissions for any diagnosis of RBS or POAS re-occurrences

    30 day

Study Arms (2)

Retrospective cohort

Prospective PleuralFlow cohort

Eligibility Criteria

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

The control arm consists of a cohort of matched cardiac surgery patients with data entered over the preceding 12 to 24-month period. The site will consecutively enroll a cohort of cardiac surgery patients in the treatment arm.

You may qualify if:

  • Male or Female subjects 18 years of age or older who received a PleuraFlow System following heart surgery.
  • Patient undergoing cardiac surgery via sternotomy

You may not qualify if:

  • Robotic surgery
  • Any access via thoracotomy
  • Intolerance to implantable silicone materials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

Study Officials

  • John Stulak, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 11, 2016

First Posted

February 15, 2016

Study Start

May 10, 2016

Primary Completion

May 1, 2018

Study Completion

March 1, 2020

Last Updated

October 29, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)