Active Clearance Technology (ACT) Registry

Retained Blood Syndrome Clinical Trial

Official title:

Prevention of Retained-Blood Outcomes With Active Clearance Technology- The ACT Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02682849
• Other study ID #: 15-006388
• Status: Completed
• Start date: May 10, 2016
• Est. completion date: March 2020

Study information

• Verified date: October 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: March 2020
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or Female subjects 18 years of age or older who received a PleuraFlow System following heart surgery.

2. Patient undergoing cardiac surgery via sternotomy

Exclusion Criteria:

1. Robotic surgery

2. Any access via thoracotomy

3. Any condition deemed inappropriate for inclusion by the investigators.

4. Intolerance to implantable silicone materials.

Related Conditions & MeSH terms

• Retained Blood Syndrome

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
John M. Stulak

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of episodes of new on set of post operative atrial fibrillations (POAS)		30 day
Secondary	Number of readmissions for any diagnosis of RBS or POAS re-occurrences		30 day

External Links

•   Mayo Clinic Clinical Trials