NCT02074254

Brief Summary

Safety of Percutaneous Tracheostomy in Clopidogrel and Selective Serotonin Reuptake Inhibitors

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2012

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
withdrawn

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

March 22, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2013

Completed
9 months until next milestone

First Posted

Study publicly available on registry

February 28, 2014

Completed
Last Updated

November 10, 2021

Status Verified

November 1, 2021

Enrollment Period

2 months

First QC Date

June 4, 2013

Last Update Submit

November 2, 2021

Conditions

Tracheostomy Complication

Outcome Measures

Primary Outcomes (1)

  • a retrospective review of our experience with bleeding complication in the presence of antiplatelet and SSRI therapy and compare the complications with those who were not on antiplatelet agents or SSRI

    24 months

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study is being done to evaluate the safety of percutaneous tracheostomy in patients taking antiplatelet agents such as aspirin and/ or clopidogrel or selective serotonin reuptake inhibitors. We will identify all patients age 18 or older who have undergone percutaneous tracheostomy by interventional pulmonology at OSUMC and access their PHI to record variables (see data collection form).

You may qualify if:

  • on antiplatelet therapy or selective serotonin reuptake inhibitors(SSRI)

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

OSUMC

Columbus, Ohio, 43210, United States

Location

University Hospital, OSUMC 473 W 12th Ave

Columbus, Ohio, 43210, United States

Location

Study Officials

  • Shaheen Islam, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2013

First Posted

February 28, 2014

Study Start

March 22, 2012

Primary Completion

May 9, 2012

Study Completion

May 9, 2012

Last Updated

November 10, 2021

Record last verified: 2021-11

Locations

US(2)