NCT03860363

Brief Summary

The purpose of this study is to evaluate the Thoraguard Surgical Drainage System in a real-world clinical environment. It is believed that this system will offer functional and clinical benefits over the current standard of care system for the removal of surgical fluids following cardiac surgery. Observations, experiences, and outcomes in a single hospital setting will be collected for the Thoraguard Surgical Drainage System.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 22, 2019

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 1, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
Last Updated

July 17, 2020

Status Verified

July 1, 2020

Enrollment Period

1.1 years

First QC Date

February 27, 2019

Last Update Submit

July 16, 2020

Conditions

Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • Device User Experience Survey

    The Device User Experience Survey is an unvalidated, Sponsor-generated questionnaire aimed to increase the Sponsor's understanding of the usability of the Thoraguard Surgical Drainage System. The questionnaire asks approximately 15 questions (includes yes/no responses, rating scales, and fill-in-the-blank sections) and is to be completed by the treating clinicians at the completion of the study. A summary of all treating clinician responses will be generated at the completion of the study to summarize the overall user experience with the device.

    At study completion - approximate 6 months.

Study Arms (1)

Treatment Group

Patients selected to participate.

Device: Blood drainage post cardiac surgery

Interventions

Blood drainage post cardiac surgeryDEVICE

Blood drainage post cardiac surgery with Thoraguard Surgical Drainage System.

Treatment Group

Eligibility Criteria

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

Non-emergent cardiac surgery patients undergoing one of the following procedures: coronary artery bypass grafting, aortic valve repair or replacement, mitral valve repair or replacement, ascending aortic surgery, a combination of these procedures, or in conjunction with additional procedures such as left ventricular aneurysm repair.

You may qualify if:

  • Adult (age ≥ 18)
  • Patient undergoing non-emergent cardiac surgery
  • Anticipated requirement for mediastinal chest tube drainage

You may not qualify if:

  • Emergency surgery
  • Re-do surgery
  • Prior cardiac surgery
  • Congenital cardiac disease or deformation
  • Transplant surgery
  • Ventricular Assist Device Surgery
  • Suspected pulmonary air leak
  • Atrial fibrillation
  • In the opinion of the investigator the patient is unsuitable for the study for any other legitimate reason including incarceration, pre-existing medical or psychiatric condition, or interfering medications
  • Known previous or concurrent enrollment in a clinical trial that, in the opinion of the investigator, might interfere with the objectives of this clinical trial
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (5)

  • 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

  • Balzer F, von Heymann C, Boyle EM, Wernecke KD, Grubitzsch H, Sander M. Impact of retained blood requiring reintervention on outcomes after cardiac surgery. J Thorac Cardiovasc Surg. 2016 Aug;152(2):595-601.e4. doi: 10.1016/j.jtcvs.2016.03.086. Epub 2016 Apr 14.

    PMID: 27210474BACKGROUND

  • Halm MA. To strip or not to strip? Physiological effects of chest tube manipulation. Am J Crit Care. 2007 Nov;16(6):609-12. No abstract available.

    PMID: 17962505BACKGROUND

  • Mahmood K, Wahidi MM. Straightening out chest tubes: what size, what type, and when. Clin Chest Med. 2013 Mar;34(1):63-71. doi: 10.1016/j.ccm.2012.11.007. Epub 2013 Jan 17.

    PMID: 23411057BACKGROUND

  • Shalli S, Saeed D, Fukamachi K, Gillinov AM, Cohn WE, Perrault LP, Boyle EM. Chest tube selection in cardiac and thoracic surgery: a survey of chest tube-related complications and their management. J Card Surg. 2009 Sep-Oct;24(5):503-9. doi: 10.1111/j.1540-8191.2009.00905.x.

    PMID: 19740284BACKGROUND

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jack Boyd, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2019

First Posted

March 1, 2019

Study Start

February 22, 2019

Primary Completion

March 30, 2020

Study Completion

May 30, 2020

Last Updated

July 17, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)