Safety of Percutaneous Tracheostomy in Clopidogrel and Se... | NCT02074254

Studies
Safety of Percutaneous Tracheostomy in Clopidogrel and Selective Serotonin Reuptake Inhibitors

NCT02074254

Sponsor

Ohio State University

Status

Withdrawn

Last Update Posted

Nov 10, 2021Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Tracheostomy Complication

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not sure. PI is no longer at OSU.

Expanded Access Info

Start Date

Mar 22, 2012Actual

Primary Completion Date

May 9, 2012Estimated

Completion Date

May 9, 2012Estimated

First Submitted Date

Jun 4, 2013

First Submission Date that Met QC Criteria

Feb 26, 2014

First Posted Date

Feb 28, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 2, 2021

Last Update Posted Date

Nov 10, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Safety of Percutaneous Tracheostomy in Clopidogrel and Selective Serotonin Reuptake Inhibitors

Detailed Description

We propose 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

on antiplatelet therapy or selective serotonin reuptake inhibitors(SSRI)

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

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).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shaheen Islam, MD	Ohio State University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
OSUMC		Columbus	Ohio	43210	United States
University Hospital, OSUMC 473 W 12th Ave