Tracheostomy ComplicationNCT02074254
Safety of Percutaneous Tracheostomy in Clopidogrel and Selective Serotonin Reuptake Inhibitors
An observational study of Tracheostomy Complication, run by Ohio State University at 2 sites in United States.
Trial summary
Safety of Percutaneous Tracheostomy in Clopidogrel and Selective Serotonin Reuptake Inhibitors Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tracheostomy Complication
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Mar 2012to 9 May 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older 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).
Who may be able to join
- on antiplatelet therapy or selective serotonin reuptake inhibitors(SSRI)
Who cannot join
- N/A
Trial locations and contacts
2 sites in 1 country.
United States2 sites
OSUMC
Columbus, Ohio, 43210
University Hospital, OSUMC 473 W 12th Ave
Columbus, Ohio, 43210
About this study
Safety of Percutaneous Tracheostomy in Clopidogrel and Selective Serotonin Reuptake Inhibitors
Read the 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.
- Conditions
- Tracheostomy Complication
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2014 (estimated)
- Study start22 Mar 2012
- Primary completion9 May 2012 (estimated)
- Study completion9 May 2012 (estimated)
Why it stopped: Not sure. PI is no longer at OSU.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheostomy ComplicationStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shaheen Islam, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02074254
- Sponsor's protocol ID
- 2012E0196
- Status last verified
- Nov 2021
- First submitted
- 4 Jun 2013
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Percutaneous Tracheostomy in Clopidogrel and Selective Serotonin Reuptake Inhibitors
- ClinicalTrials.gov ID
- NCT02074254
- Acronym / sponsor ID
- 2012E0196
- Conditions
- Tracheostomy Complication
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Not sure. PI is no longer at OSU.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 22 Mar 2012 (actual)
- Primary completion
- 9 May 2012 (estimated)
- Study completion
- 9 May 2012 (estimated)
- First posted
- 28 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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).
Key inclusion criteria (1 listed)
- on antiplatelet therapy or selective serotonin reuptake inhibitors(SSRI)
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaheen Islam, MD principal investigator
Ohio State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tracheostomy Complication, run by Ohio State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2021.