NCT02479737

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,113

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed
9 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 2, 2017

Status Verified

April 1, 2017

Enrollment Period

1.2 years

First QC Date

June 17, 2015

Last Update Submit

April 28, 2017

Conditions

Heart Surgery

Keywords

Chest tubechest drainageretained blood complicationschest tube clogginghemothoraxtamponadeheart surgerypleural effusionintensive care

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Blood drainage post cardiac surgery using PleuraFlow SystemDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects older than 18 years 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

You may not qualify if:

  • Infants, children and adolescents under the age of 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Herz- und Gefäßklinik GmbH

Bad Neustadt an der Saale, Bavaria, 97616, Germany

RECRUITING

Paracelsus Medical University, Klinikum, Nuremberg, Germany

Nuremberg, Bavaria, 90471, Germany

RECRUITING

Related Publications (14)

  • 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. doi: 10.1016/j.hrtlng.2006.05.006.

    PMID: 17234475BACKGROUND

  • 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.

    PMID: 22100857BACKGROUND

  • 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.

    PMID: 22574710BACKGROUND

  • 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: 16088710BACKGROUND

  • 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: 12055394BACKGROUND

  • 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: 10375337BACKGROUND

  • 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: 12406850BACKGROUND

  • 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: 3260740BACKGROUND

  • 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. doi: 10.1016/j.ejcts.2006.12.010. Epub 2007 Jan 9.

    PMID: 17215136BACKGROUND

  • 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: 23520232BACKGROUND

  • 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: 22437275BACKGROUND

  • 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: 20179137BACKGROUND

  • 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: 21256318BACKGROUND

  • 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: 23274869BACKGROUND

MeSH Terms

Conditions

HemothoraxPleural Effusion

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Theodor Fischlein, Prof.

    Paracelsus Medical University, Klinikum, Nuremberg, Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Theodor Fischlein, Prof.

CONTACT

0049 911 398mailto:tatjana.lueg@klinikum-nuernberg.de

Joachim Sirch, Dr

CONTACT

0049 911 398mailto:tatjana.lueg@klinikum-nuernberg.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head, Department of Cardiac Surgery

Study Record Dates

First Submitted

June 17, 2015

First Posted

June 24, 2015

Study Start

April 1, 2016

Primary Completion

July 1, 2017

Study Completion

December 1, 2017

Last Updated

May 2, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)