Clinical Trial: Prevention of Retained-Blood Outcomes With Active Clearance Technology

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: Prevention of Retained-Blood Outcomes With Active Clearance Technology. ACT Registry

Brief Summary:

Postoperative bleeding is a common consequence after heart surgery which can significantly impact outcomes and costs [Wynne R, Christensen MC, Dixon B]. 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 post operative blood evacuation is inadequate, retained blood complications can result (herein described as the Retained Blood Complications (RBC). RBC is the presence of post-operative pericardial and/or pleural fluid or blood that is diagnosed and may necessitate drainage in the acute or subacute setting. 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. Clinically, Retained Blood Complications (RBC) can be recognized acutely or subacutely. When it presents acutely, it is usually fresh thrombus around the heart or lungs presenting as tamponade or hemothorax. When it presents subacutely, it results in bloody pleural or pericardial effusions [Light RW, Light RW, Light RW, Ikaheimo MJ]. These effusions are often driven by the breakdown of remaining thrombus. Once RBC occurs, subsequent procedures may be needed to remedy it. A recent review of the literature indicated that additional procedures for RBC are demonstrated in approximately 15% to 20% of patients after heart surgery. In a prospectively collected United States Nationwide Inpatient Sample (NIS) data from 2010, RBC 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 RBC, therefore, represent an increased at risk population for complications and costs.

This is a prospective multicenter observational registry with a retrospective component. 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 enter into the registry database 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 with the prospective data sets collected during the prospective enrollment phase.

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 product use and with ACT. 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 mai
Sponsor: ClearFlow, Inc.

Current Primary Outcome: Incidence of Retained Blood Complications (RBC) [ Time Frame: surgery to post-operative 30 days ]

The incidence of RBC as defined by a composite endpoint of specific interventions and diagnoses. Any patient that has a record of any of the following interventions or diagnosis post-operative including post discharge has RBC.

  • Interventions

    • Reoperation for bleeding, tamponade or washout of retained blood
    • Pericardial window
    • Chest tube placement/replacement
    • Pericardiocentesis
    • Placement of pericardial drain
    • Thoracotomy
    • Thoracoscopy
    • Thoracentesis

  • Diagnoses

    • Pleural effusion
    • Pericardial effusion
    • Hemothorax
    • Pneumothorax
    • Pericardial tamponade


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: ClearFlow, Inc.

Dates:
Date Received: May 21, 2014
Date Started: June 2014
Date Completion: October 2016
Last Updated: October 21, 2015
Last Verified: October 2015