Prevention of Retained-Blood Outcomes With Active Clearance Technology

NCT02145858 | Completed FDA Device

• 1 other identifier: CL2014001
• Study Type: observational
• Target: 891
• Locations: 1 country
• Sites: 2

Brief 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

Hemorrhage; Atrial Fibrillation, Postoperative

Keywords

atrial fibrillation, pericardial effusion, pleural effusion

Outcome Measures

Primary Outcomes (1)

• Incidence of Retained Blood Syndrome (RBS)

  The incidence of RBS as defined by a composite endpoint of specific interventions and diagnoses. Any patient that has a record of any of the following interventions or diagnoses post-operatively including post-discharge, will be considered to have RBS. * 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

  surgery to post-operative 30 days

Interventions

Blood drainage post cardiac surgery using PleuraFlow System DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects 18 years or older who received a PleuraFlow System following heart surgery

You may qualify if:

• Male or Female subjects 18 years or older who received a PleuraFlow System following heart surgery.
• Patient undergoing cardiac surgery via sternotomy.

You may not qualify if:

• Infants, children and adolescents under the age of 18.
• Robotic surgery.
• Any access via thoracotomy.
• Intolerance to implantable silicone materials.

Sponsors & Collaborators

• ClearFlow, Inc.: lead
• Vanderbilt University Medical Center: collaborator
• Catholic Medical Center: collaborator

Study Sites (2)

Catholic Medical Center

Manchester, New Hampshire, 03102, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-8802, United States

Location

Related Publications (14)

• Boyle EM Jr, Gillinov AM, Cohn WE, Ley SJ, Fischlein T, Perrault LP. Retained Blood Syndrome After Cardiac Surgery: A New Look at an Old Problem. Innovations (Phila). 2015 Sep-Oct;10(5):296-303. doi: 10.1097/IMI.0000000000000200.

  PMID: 26575376 BACKGROUND

• Light RW. Pleural effusions following cardiac injury and coronary artery bypass graft surgery. Semin Respir Crit Care Med. 2001 Dec;22(6):657-64. doi: 10.1055/s-2001-18802.

  PMID: 16088710 BACKGROUND

• Light RW. Pleural effusions after coronary artery bypass graft surgery. Curr Opin Pulm Med. 2002 Jul;8(4):308-11. doi: 10.1097/00063198-200207000-00011.

  PMID: 12055394 BACKGROUND

• 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. doi: 10.7326/0003-4819-130-11-199906010-00004.

  PMID: 10375337 BACKGROUND

• 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. doi: 10.1164/rccm.200203-184OC. Epub 2002 Oct 11.

  PMID: 12406850 BACKGROUND

• Ikaheimo 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. doi: 10.1016/0002-8703(88)90255-4.

  PMID: 3260740 BACKGROUND

• 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.

  PMID: 22437275 BACKGROUND

• 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.

  PMID: 23520232 BACKGROUND

• 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.

  PMID: 20179137 BACKGROUND

• 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.

  PMID: 21256318 BACKGROUND

• 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.

  PMID: 23274869 BACKGROUND

• Sirch J, Ledwon M, Puski T, Boyle EM, Pfeiffer S, Fischlein T. Active clearance of chest drainage catheters reduces retained blood. J Thorac Cardiovasc Surg. 2016 Mar;151(3):832-838.e2. doi: 10.1016/j.jtcvs.2015.10.015. Epub 2015 Oct 22.

  PMID: 26611748 BACKGROUND

• Baribeau Y, Westbrook B, Baribeau Y, Maltais S, Boyle EM, Perrault LP. Active clearance of chest tubes is associated with reduced postoperative complications and costs after cardiac surgery: a propensity matched analysis. J Cardiothorac Surg. 2019 Nov 8;14(1):192. doi: 10.1186/s13019-019-0999-3.

  PMID: 31703606 DERIVED

• Maltais S, Davis ME, Haglund NA, Perrault L, Kushwaha SS, Stulak JM, Boyle EM. Active Clearance of Chest Tubes Reduces Re-Exploration for Bleeding After Ventricular Assist Device Implantation. ASAIO J. 2016 Nov/Dec;62(6):704-709. doi: 10.1097/MAT.0000000000000437.

  PMID: 27556153 DERIVED

MeSH Terms

Conditions

Hemorrhage; Atrial Fibrillation; Pericardial Effusion; Pleural Effusion

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Simon Maltais, MD

  Mayo Clinic, Rochester, MN

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2014
• First Posted: May 23, 2014
• Study Start: June 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: November 30, 2016
• Last Updated: May 17, 2018

Record last verified: 2018-05

Locations

US (2)