Active Clearance Technology (ACT) II German Multicenter Trial

Heart Surgery Clinical Trial

Official title:

The Active Clearance Technology (ACT) II German Multicenter Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02479737
• Other study ID #: Germany-ACT II
• Status: Recruiting
• Phase: N/A
• First received: June 17, 2015
• Last updated: April 28, 2017
• Start date: April 2016
• Est. completion date: December 2017

Study information

• Verified date: April 2017
• Source: Paracelsus Medical University
• Contact: Theodor Fischlein, Prof.
• Phone: 0049 911 398
• Email: mailto:tatjana.lueg[@]klinikum-nuernberg.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1113
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Surgery

Intervention

Device:
• Blood drainage post cardiac surgery using PleuraFlow System

Locations

Country	Name	City	State
Germany	Herz- und Gefäßklinik GmbH	Bad Neustadt an der Saale	Bavaria
Germany	Paracelsus Medical University, Klinikum, Nuremberg, Germany	Nuremberg	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
Prof. Dr. Theodor Fischlein	ClearFlow, Inc.

Country where clinical trial is conducted

Germany, 

References & Publications (14)

Arakawa Y, Shiose A, Takaseya T, Fumoto H, Kim HI, Boyle EM, Gillinov AM, Fukamachi K. Superior chest drainage with an active tube clearance system: evaluation of a downsized chest tube. Ann Thorac Surg. 2011 Feb;91(2):580-3. doi: 10.1016/j.athoracsur.2010.10.018. — View Citation

Christensen MC, Dziewior F, Kempel A, von Heymann C. Increased chest tube drainage is independently associated with adverse outcome after cardiac surgery. J Cardiothorac Vasc Anesth. 2012 Feb;26(1):46-51. doi: 10.1053/j.jvca.2011.09.021. Epub 2011 Nov 18. — View Citation

Clark G, Licker M, Bertin D, Spiliopoulos A. Small size new silastic drains: life-threatening hypovolemic shock after thoracic surgery associated with a non-functioning chest tube. Eur J Cardiothorac Surg. 2007 Mar;31(3):566-8. Epub 2007 Jan 9. — View Citation

Dixon B, Santamaria JD, Reid D, Collins M, Rechnitzer T, Newcomb AE, Nixon I, Yii M, Rosalion A, Campbell DJ. The association of blood transfusion with mortality after cardiac surgery: cause or confounding? (CME). Transfusion. 2013 Jan;53(1):19-27. doi: 10.1111/j.1537-2995.2012.03697.x. Epub 2012 May 11. — View Citation

Ikäheimo MJ, Huikuri HV, Airaksinen KE, Korhonen UR, Linnaluoto MK, Tarkka MR, Takkunen JT. Pericardial effusion after cardiac surgery: incidence, relation to the type of surgery, antithrombotic therapy, and early coronary bypass graft patency. Am Heart J. 1988 Jul;116(1 Pt 1):97-102. — View Citation

Karimov JH, Gillinov AM, Schenck L, Cook M, Kosty Sweeney D, Boyle EM, Fukamachi K. Incidence of chest tube clogging after cardiac surgery: a single-centre prospective observational study. Eur J Cardiothorac Surg. 2013 Dec;44(6):1029-36. doi: 10.1093/ejcts/ezt140. Epub 2013 Mar 21. — View Citation

Light RW, Rogers JT, Cheng D, Rodriguez RM. Large pleural effusions occurring after coronary artery bypass grafting. Cardiovascular Surgery Associates, PC. Ann Intern Med. 1999 Jun 1;130(11):891-6. — View Citation

Light RW, Rogers JT, Moyers JP, Lee YC, Rodriguez RM, Alford WC Jr, Ball SK, Burrus GR, Coltharp WH, Glassford DM Jr, Hoff SJ, Lea JW 4th, Nesbitt JC, Petracek MR, Starkey TD, Stoney WS, Tedder M. Prevalence and clinical course of pleural effusions at 30 days after coronary artery and cardiac surgery. Am J Respir Crit Care Med. 2002 Dec 15;166(12 Pt 1):1567-71. Epub 2002 Oct 11. — View Citation

Light RW. Pleural effusions after coronary artery bypass graft surgery. Curr Opin Pulm Med. 2002 Jul;8(4):308-11. Review. — View Citation

Light RW. Pleural effusions following cardiac injury and coronary artery bypass graft surgery. Semin Respir Crit Care Med. 2001 Dec;22(6):657-64. — View Citation

Perrault LP, Pellerin M, Carrier M, Cartier R, Bouchard D, Demers P, Boyle EM. The PleuraFlow Active Chest Tube Clearance System: initial clinical experience in adult cardiac surgery. Innovations (Phila). 2012 Sep-Oct;7(5):354-8. doi: 10.1097/IMI.0b013e31827e2b4d. — View Citation

Shalli S, Boyle EM, Saeed D, Fukamachi K, Cohn WE, Gillinov AM. The active tube clearance system: a novel bedside chest-tube clearance device. Innovations (Phila). 2010 Jan;5(1):42-7. doi: 10.1097/IMI.0b013e3181cf7ce3. — View Citation

Shiose A, Takaseya T, Fumoto H, Arakawa Y, Horai T, Boyle EM, Gillinov AM, Fukamachi K. Improved drainage with active chest tube clearance. Interact Cardiovasc Thorac Surg. 2010 May;10(5):685-8. doi: 10.1510/icvts.2009.229393. Epub 2010 Feb 23. — View Citation

Wynne R, Botti M, Copley D, Bailey M. The normative distribution of chest tube drainage volume after coronary artery bypass grafting. Heart Lung. 2007 Jan-Feb;36(1):35-42. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent reduction in the rate of interventions to treat Retained Blood Syndrome (RBS)	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	participants will be followed for the duration of hospital stay, an expected average of 12 days

External Links

•   World Medical Association Declaration of HelsinkiEthical Principles for Medical Research Involving Human Subjects