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Active Clearance Technology (ACT) II German Multicenter Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02479737
Recruitment Status : Recruiting
First Posted : June 24, 2015
Last Update Posted : May 2, 2017
ClearFlow, Inc.
Information provided by (Responsible Party):
Prof. Dr. Theodor Fischlein, Paracelsus Medical University

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 re-expansion and mediastinal decompression as the patient recovers. When postoperative 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 sub-acute 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. 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.

Postoperative obstruction of conventional chest tubes with blood and other fibrinous material in the setting of postoperative bleeding contributes to RBC. (Shalli) In a recent 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 RBC.

Condition or disease Intervention/treatment
Heart Surgery Device: Blood drainage post cardiac surgery using PleuraFlow System

Detailed Description:

Complications from RBS are defined as those requiring re-operation or surgical interventions to evacuate blood, blood clot, bloody fluid, and air accumulation within the operative site after closure of the surgical wound. This is a prospective multicenter observational post-market study with a retrospective component. The study is open to up to five (5) German sites enrolling a consecutive cohort of cardiac surgery patients.

There are two conditions for participation in this registry. First, sites are required to enter into the study 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. Second, sites that have not been using the PleuraFlow System before enrolling patients to this study 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1113 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Official Title: The Active Clearance Technology (ACT) II German Multicenter Trial
Study Start Date : April 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Primary Outcome Measures :
  1. Percent reduction in the rate of interventions to treat Retained Blood Syndrome (RBS) [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 12 days ]

    RBS is a composite endpoint defined as an intervention to treat one or more of the following conditions:

    -Re-exploration for bleeding, tamponade or washout of retained bloo

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects older than 18 years who received a PleuraFlow System following heart surgery

Inclusion Criteria:

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

Exclusion Criteria:

  1. Any condition deemed inappropriate for inclusion by the investigators
  2. Infants, children and adolescents under the age of 18

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02479737

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Contact: Theodor Fischlein, Prof. 0049 911 398 ext 5441
Contact: Joachim Sirch, Dr 0049 911 398 ext 5441

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Herz- und Gefäßklinik GmbH Recruiting
Bad Neustadt an der Saale, Bavaria, Germany, 97616
Contact: Anno Diegeler, Prof. Dr. med.    +49 9771 66 ext 2417   
Contact: Monika Back    +49 9771 66 ext 5690   
Paracelsus Medical University, Klinikum, Nuremberg, Germany Recruiting
Nuremberg, Bavaria, Germany, 90471
Contact: Theodor Fischlein, Prof.    0049 911 398 ext 5441   
Contact: Joachim Sirch, Dr.    0049 911 398 ext 5441   
Sponsors and Collaborators
Prof. Dr. Theodor Fischlein
ClearFlow, Inc.
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Principal Investigator: Theodor Fischlein, Prof. Paracelsus Medical University, Klinikum, Nuremberg, Germany

Additional Information:

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Responsible Party: Prof. Dr. Theodor Fischlein, Head, Department of Cardiac Surgery, Paracelsus Medical University Identifier: NCT02479737     History of Changes
Other Study ID Numbers: Germany-ACT II
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Prof. Dr. Theodor Fischlein, Paracelsus Medical University:
Chest tube
chest drainage
retained blood complications
chest tube clogging
heart surgery
pleural effusion
intensive care