Prevention of Retained-Blood Outcomes With Active Clearance Technology
| Status: | Completed |
|---|---|
| Conditions: | Atrial Fibrillation, Hospital |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/19/2018 |
| Start Date: | June 2014 |
| End Date: | November 30, 2016 |
Prevention of Retained-Blood Outcomes With Active Clearance Technology. ACT Registry
Postoperative bleeding is a common consequence after heart surgery which can significantly
impact outcomes and costs . When bleeding occurs, reliable postoperative blood evacuation of
the pleural, mediastinal and pericardial spaces with chest tubes is imperative to facilitate
pulmonary reexpansion and mediastinal decompression as the patient recovers. When
postoperative blood evacuation is inadequate, complications from retained blood can result.
Clinically, retained blood may be recognized acutely or sub acutely. The acute clinical
presentation is usually blood and fresh thrombus around the heart or lungs presenting as
tamponade or hemothorax. The subacute clinical presentation is bloody pleural or pericardial
effusions. These effusions are often driven by the breakdown of remaining thrombus. Once
retained blood occurs, subsequent procedures may be needed to remedy it. Interventions to
remove postoperative pericardial and/or pleural fluid or blood and reoperations due to
bleeding are captured under a composite termed Retained Blood Syndrome, or RBS. The need for
treatment and interventions for these conditions represents an impediment to patient recovery
and involves both resource and economic consumption for a heart program and the healthcare
system at large.
A recent review of the literature indicates that additional procedures for RBS are
demonstrated in approximately 15% to 20% of patients after heart surgery. In a prospectively
collected US Nationwide Inpatient Sample (NIS) data from 2010, RBS could be demonstrated in
17% of patients. In this analysis, mortality was doubled from 4% to 8%, length of stay was
increased by 5 days, and average costs were 55% higher. Patients with RBS, therefore,
represent an increased at-risk population for complications and costs.
Postoperative obstruction of conventional chest tubes with blood and other fibrinous material
in the setting of postoperative bleeding contributes to RBS. In a study of postoperative
cardiac surgery patients at the Cleveland Clinic, 36% of patients were found to have evidence
of chest tube obstruction. Active Clearance with PleuraFlow has been shown to prevent chest
tube clogging, and reduce RBS.
The purpose of this registry is to evaluate the effectiveness of the PleuraFlow System, a
commercial Class II (US), Class IIb (Canada, Europe, and Australia), in the management of
blood evacuation after cardiac surgery.
impact outcomes and costs . When bleeding occurs, reliable postoperative blood evacuation of
the pleural, mediastinal and pericardial spaces with chest tubes is imperative to facilitate
pulmonary reexpansion and mediastinal decompression as the patient recovers. When
postoperative blood evacuation is inadequate, complications from retained blood can result.
Clinically, retained blood may be recognized acutely or sub acutely. The acute clinical
presentation is usually blood and fresh thrombus around the heart or lungs presenting as
tamponade or hemothorax. The subacute clinical presentation is bloody pleural or pericardial
effusions. These effusions are often driven by the breakdown of remaining thrombus. Once
retained blood occurs, subsequent procedures may be needed to remedy it. Interventions to
remove postoperative pericardial and/or pleural fluid or blood and reoperations due to
bleeding are captured under a composite termed Retained Blood Syndrome, or RBS. The need for
treatment and interventions for these conditions represents an impediment to patient recovery
and involves both resource and economic consumption for a heart program and the healthcare
system at large.
A recent review of the literature indicates that additional procedures for RBS are
demonstrated in approximately 15% to 20% of patients after heart surgery. In a prospectively
collected US Nationwide Inpatient Sample (NIS) data from 2010, RBS could be demonstrated in
17% of patients. In this analysis, mortality was doubled from 4% to 8%, length of stay was
increased by 5 days, and average costs were 55% higher. Patients with RBS, therefore,
represent an increased at-risk population for complications and costs.
Postoperative obstruction of conventional chest tubes with blood and other fibrinous material
in the setting of postoperative bleeding contributes to RBS. In a study of postoperative
cardiac surgery patients at the Cleveland Clinic, 36% of patients were found to have evidence
of chest tube obstruction. Active Clearance with PleuraFlow has been shown to prevent chest
tube clogging, and reduce RBS.
The purpose of this registry is to evaluate the effectiveness of the PleuraFlow System, a
commercial Class II (US), Class IIb (Canada, Europe, and Australia), in the management of
blood evacuation after cardiac surgery.
This is a prospective multicenter observational registry with a retrospective control. The
registry has two tracks. One track--ALL-ACT-- is for sites enrolling a consecutive cohort of
all cardiac surgery patients (Track A). The second track--VAD-ACT-- is for sites enrolling
patients post ventricular assist device (VAD) surgery (Track B). There are two conditions for
participation in this registry:
First, sites are required to provide anonymized matched historical data elements from a
cohort of cardiac surgery patients done over the preceding 12 to 24-month period (Phase 0).
These retrospective data elements will be used as baseline information for the purpose of
comparative analyses (control group) with the prospective data sets collected during the
prospective enrollment phase (treatment group).
Second, sites are required to participate in a roll-in phase (Phase 1). The purposes of the
roll-in phase are to allow the users at participating sites to familiarize themselves with
the use of the product with Active Clearance Technology; to implement clinical use protocols
provided by ClearFlow, Inc. to all commercial users as part of product training, and; to
demonstrate consistency and compliance with the clinical use protocols.
Phase 0 and phase 1 can be executed in parallel. Participating sites may start prospective
enrollment (Phase 2) after completion of phase 0 and 1.
Investigators shall report PleuraFlow-related serious injuries to Sponsor as soon as becoming
aware of the injury and no later than 48 hours.
Investigators shall report deaths to both the Sponsor and Regulatory authorities in
compliance with their applicable State, Country and conditions imposed by the reviewing
Ethical Committee. The three main guidance documents for reporting recall and vigilance
procedure of medical devices are, 21 CFR, Part 806, MEDDEV 2.12/1 rev8 Guidelines on a
Medical Devices Vigilance System, and Health Canada Medical Device Regulations SOR/98-282.
Vanderbilt University will create a REDCap database specific to this study and administer it.
The Vanderbilt database study administrator will control database access, oversee data entry
and data transfer from each participating site. Database manager will monitor the REDCap
database and ensure data completeness and security. The database manager will maintain
contact will the data entry personnel from each site and ensure whether data capture is
occurring and determine the number of patients expected to be enrolled in the Registry at the
end of the study period. Sponsor will not have access to REDCap once the study is complete.
The REDCap database is secure and HIPAA compliant.
Descriptive statistics for categorical variables will be reported as percentages, and
continuous variables will be reported as mean ± standard deviation (SD). Categorical
variables will be compared using the chi-square test. Continuous variables will be compared
using a Student's t-test as appropriate.
Database study administrator will coordinate the generation of data reports and statistical
outputs. Sponsor will not have access to REDCap once the study is complete.
registry has two tracks. One track--ALL-ACT-- is for sites enrolling a consecutive cohort of
all cardiac surgery patients (Track A). The second track--VAD-ACT-- is for sites enrolling
patients post ventricular assist device (VAD) surgery (Track B). There are two conditions for
participation in this registry:
First, sites are required to provide anonymized matched historical data elements from a
cohort of cardiac surgery patients done over the preceding 12 to 24-month period (Phase 0).
These retrospective data elements will be used as baseline information for the purpose of
comparative analyses (control group) with the prospective data sets collected during the
prospective enrollment phase (treatment group).
Second, sites are required to participate in a roll-in phase (Phase 1). The purposes of the
roll-in phase are to allow the users at participating sites to familiarize themselves with
the use of the product with Active Clearance Technology; to implement clinical use protocols
provided by ClearFlow, Inc. to all commercial users as part of product training, and; to
demonstrate consistency and compliance with the clinical use protocols.
Phase 0 and phase 1 can be executed in parallel. Participating sites may start prospective
enrollment (Phase 2) after completion of phase 0 and 1.
Investigators shall report PleuraFlow-related serious injuries to Sponsor as soon as becoming
aware of the injury and no later than 48 hours.
Investigators shall report deaths to both the Sponsor and Regulatory authorities in
compliance with their applicable State, Country and conditions imposed by the reviewing
Ethical Committee. The three main guidance documents for reporting recall and vigilance
procedure of medical devices are, 21 CFR, Part 806, MEDDEV 2.12/1 rev8 Guidelines on a
Medical Devices Vigilance System, and Health Canada Medical Device Regulations SOR/98-282.
Vanderbilt University will create a REDCap database specific to this study and administer it.
The Vanderbilt database study administrator will control database access, oversee data entry
and data transfer from each participating site. Database manager will monitor the REDCap
database and ensure data completeness and security. The database manager will maintain
contact will the data entry personnel from each site and ensure whether data capture is
occurring and determine the number of patients expected to be enrolled in the Registry at the
end of the study period. Sponsor will not have access to REDCap once the study is complete.
The REDCap database is secure and HIPAA compliant.
Descriptive statistics for categorical variables will be reported as percentages, and
continuous variables will be reported as mean ± standard deviation (SD). Categorical
variables will be compared using the chi-square test. Continuous variables will be compared
using a Student's t-test as appropriate.
Database study administrator will coordinate the generation of data reports and statistical
outputs. Sponsor will not have access to REDCap once the study is complete.
Inclusion Criteria:
- Male or Female subjects 18 years or older who received a PleuraFlow System following
heart surgery.
- Patient undergoing cardiac surgery via sternotomy.
Exclusion Criteria:
- Any condition deemed inappropriate for inclusion by the investigators.
- Infants, children and adolescents under the age of 18.
- Robotic surgery.
- Any access via thoracotomy.
- Intolerance to implantable silicone materials.
We found this trial at
2
sites
Manchester, New Hampshire 03102
Principal Investigator: Benjamin Westbrook, MD
Phone: 603-391-4432
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Simon Maltais, MD, PhD
Phone: 615-343-9195
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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