MedTrace Logo

Prevention of Retained-Blood Outcomes With Active Clearance Technology

NCT02145858 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 891

Last updated 2018-05-17

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Blood drainage post cardiac surgery using PleuraFlow System

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    collaborator OTHER

  • Catholic Medical Center

    collaborator OTHER

  • ClearFlow, Inc.

    lead INDUSTRY

Principal Investigators

  • Simon Maltais, MD · Mayo Clinic, Rochester, MN

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2016-07-31
Completion
2016-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02145858 on ClinicalTrials.gov