NCT02375542

Brief Summary

This study will analyse factors contributing to cardiac re-operation to determine causative effects

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2015

Typical duration for all trials

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

First Submitted

Initial submission to the registry

August 19, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 2, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

July 19, 2018

Status Verified

July 1, 2018

Enrollment Period

2.9 years

First QC Date

August 19, 2014

Last Update Submit

July 18, 2018

Conditions

Aortic AneurysmAortic Dissection

Outcome Measures

Primary Outcomes (1)

  • The microscopic evaluation of the presence of BioGlue on aortic tissue

    "participants will be followed for the duration of their surgery, an expected average of 5 hours

Secondary Outcomes (1)

  • Observation and characterization of BioGlue usage during the reoperation procedure

    "participants will be followed for the duration of their surgery, an expected average of 5 hours

Study Arms (1)

Cardiac Reoperation

Patients who have previously undergone a cardiac operation with the use of BioGlue and are now undergoing a reoperation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Prospective, Single center, single arm study.

You may qualify if:

  • Subjects undergoing an aortic re-operation
  • Subject has had BioGlue used during previous aortic surgery
  • Subject is willing and able to give written informed consent for participation

You may not qualify if:

  • Subject with a history of vasculitis
  • Subject with active infection (endocarditis)
  • Subject with a history of chronic inflammatory condition which may have led to ongoing tissue damage
  • Subject with a history of auto immune disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

S.Orsola Malpighi Hospital

Bologna, 40138, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples of aortic tissue which are removed as standard practice during surgery

MeSH Terms

Conditions

Aortic AneurysmAortic Dissection

Condition Hierarchy (Ancestors)

AneurysmVascular DiseasesCardiovascular DiseasesAortic DiseasesDissection, Blood VesselAcute Aortic Syndrome

Study Officials

  • Davide Pacini, Dr

    Cardiac Surgeon

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 19, 2014

First Posted

March 2, 2015

Study Start

February 1, 2015

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

July 19, 2018

Record last verified: 2018-07

Locations

IT(1)