Post-polypectomy BleedingNCT01647568
Safety of Continuing Anti-platelet Agents During Colonoscopic Polypectomy: A Prospective Study
An observational study of Post-polypectomy Bleeding and Anti-platelet Therapy, run by Dallas VA Medical Center at 1 site in United States.
Trial summary
At our VA hospital, in general, it is the policy of our GI lab to not stop our patients anti-platelet therapy whenever they see us for a routine colonoscopy. We do this because we believe the risk of stopping these sort of medications outweigh the risks of a complication from a colonoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-polypectomy Bleeding, Anti-platelet Therapy, Colonoscopy
- How many people
- 715 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to the GI lab for elective colonoscopy.
Who may be able to join
- Patients presenting to the GI lab for elective colonoscopy
Who cannot join
- Patients on Coumadin or other anti-coagulants
- Patients with Inflammatory Bowel Disease
Trial locations and contacts
1 site in 1 country.
About this study
At our VA hospital, in general, it is the policy of our GI lab to not stop our patients anti-platelet therapy whenever they see us for a routine colonoscopy. We do this because we believe the risk of stopping these sort of medications outweigh the risks of a complication from a colonoscopy.
Therefore, we are enrolling patients who are either on clopidogrel or prasugrel or not on any anti-platelet/anti-coagulant therapy that come to our GI lab routine colonoscopies. We perform the procedure just like we normally would and then follow-up with the patient 7 and 30 days after their procedure.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Patients who are not on any anti-platelet/anti-coagulant therapy and present to our lab for a elective colonoscopy. | |
| Thienopyridine Users | Patients on Clopidogrel or prasugrel when they present for an elective colonoscopy. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2012 (estimated)
- Study startDec 2009
- Primary completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-polypectomy BleedingStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 715 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dallas VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Linda A Feagins, Dallas VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01647568
- Sponsor's protocol ID
- DVAMC-09-084
- Status last verified
- Jul 2012
- First submitted
- 19 Jul 2012
- Last updated
- 23 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Feagins LA, Iqbal R, Harford WV, Halai A, Cryer BL, Dunbar KB, Davila RE, Spechler SJ. Low rate of postpolypectomy bleeding among patients who continue thienopyridine therapy during colonoscopy. Clin Gastroenterol Hepatol. 2013 Oct;11(10):1325-32. doi: 10.1016/j.cgh.2013.02.003. Epub 2013 Feb 9.
PubMed 23403011
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Continuing Anti-platelet Agents During Colonoscopic Polypectomy: A Prospective Study
- ClinicalTrials.gov ID
- NCT01647568
- Acronym / sponsor ID
- DVAMC-09-084
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 715 participants (actual)
- Lead sponsor
- Dallas VA Medical CenterUS federal agency
- Study start
- Dec 2009
- Primary completion
- Mar 2012 (actual)
- First posted
- 23 Jul 2012 (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.
At our VA hospital, in general, it is the policy of our GI lab to not stop our patients anti-platelet therapy whenever they see us for a routine colonoscopy. We do this because we believe the risk of stopping these sort of medications outweigh the risks of a complication from a colonoscopy.
Therefore, we are enrolling patients who are either on clopidogrel or prasugrel or not on any anti-platelet/anti-coagulant therapy that come to our GI lab routine colonoscopies. We perform the procedure just like we normally would and then follow-up with the patient 7 and 30 days after their procedure.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Patients who are not on any anti-platelet/anti-coagulant therapy and present to our lab for a elective colonoscopy. |
| Thienopyridine Users | – | –Patients on Clopidogrel or prasugrel when they present for an elective colonoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the GI lab for elective colonoscopy.
Key inclusion criteria (1 listed)
- Patients presenting to the GI lab for elective colonoscopy
Key exclusion criteria (2 listed)
- Patients on Coumadin or other anti-coagulants
- Patients with Inflammatory Bowel Disease
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2012.
- Derived from this study: PubMed 23403011Feagins LA, Iqbal R, Harford WV, Halai A, Cryer BL, Dunbar KB, Davila RE, Spechler SJ. Low rate of postpolypectomy bleeding among patients who continue thienopyridine therapy during colonoscopy. Clin Gastroenterol Hepatol. 2013 Oct;11(10):1325-32. doi: 10.1016/j.cgh.2013.02.003. Epub 2013 Feb 9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-polypectomy Bleeding and Anti-platelet Therapy, run by Dallas VA Medical Center at 1 site 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 2 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: finished, as of the sponsor's last update on 23 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01647568, which also lists 1 linked publication.
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 23 Jul 2012.