Retained Blood Syndrome Clinical Trial
Official title:
Prevention of Retained-Blood Outcomes With Active Clearance Technology- The ACT Registry
NCT number | NCT02682849 |
Other study ID # | 15-006388 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 10, 2016 |
Est. completion date | March 2020 |
Verified date | October 2020 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
The purpose of this study is to evaluate the effectiveness of the PleuraFlow® Active Clearance Technologyâ„¢ (ACT) System in the management of blood evacuation after cardiac surgery.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
John M. Stulak |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT05308589 -
CPPF After General Cardiac Surgery
|
N/A |