Gastrointestinal BleedingNCT01415869
Occult Gastrointestinal Bleeding in Non-pulsatile Left Ventricular Assist Device(VAD)Patients
An observational study of Gastrointestinal Bleeding and Complication of Internal Device, run by Mayo Clinic at 2 sites in United States.
Trial summary
The purpose of this study is to estimate the proportion of Ventricular Assist Device (VAD) patients with abnormal gastrointestinal bleeding as assessed by HemoQuant fecal occult blood test. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Bleeding, Complication of Internal Device
- How many people
- 38 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Jun 2011to 22 Jun 2013
- 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: * Group 1 Patients with implanted non-pulsatile ventricular assist devices of any type and at any time after implantation * Group 2 Patients with usual VAD indications will be invited to participate, when, in the opinion of their treating physician a VAD will be highly likely within one month.
Who may be able to join
- Group 1 - cross sectional study. Patients with implanted non-pulsatile ventricular assist devices of any type and at any time after implantation
- Group 2 - prospective study. Patients with usual VAD indications will be invited to participate, when, in the opinion of their treating physician a VAD will be highly likely within one month.
Who cannot join
- Unwillingness to provide stool samples for study
- Unwillingness to be followed for study endpoints.
- Unwillingness to follow dietary restrictions necessary for accurate HemaQuant measurement
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic
Jacksonville, Florida, 32224
Mayo Clinic
Rochester, Minnesota, 55905
About this study
The purpose of this study is to estimate the proportion of Ventricular Assist Device (VAD) patients with abnormal gastrointestinal bleeding as assessed by HemoQuant fecal occult blood test. Also, in patients with gastrointestinal bleeding present, to summarize the extent of gastrointestinal bleeding; to examine the behavior of HemoQuant fecal occult blood test over time by estimating the proportion of VAD patients with a positive test prior to implantation; at one week, one month, three months, six months and one year post implantation, and after explantation of the VAD and to evaluate whether presence of any abnormal fecal HemoQuant test is predictive of a future major bleeding event.
- Keywords
- Ventricular Assist Device, Gastrointestinal Bleeding, VAD
- Medical subject headings
- Gastrointestinal Hemorrhage
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 |
|---|---|---|
| Cross Sectional | Patients with implanted non-pulsatile ventricular assist devices of any type and at any time after implantation | |
| Prospective | Patients with usual VAD indications will be invited to participate, when, in the opinion of their treating physician a VAD will be highly likely within one month. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of VAD Patients with Gastrointestinal Bleeding as Assessed by HemoQuant Fecal Occult Blood Testing
We will estimate the proportion of VAD patients with gastrointestinal bleeding as assessed by HemoQuant fecal occult blood test along with an exact binomial 95% confidence interval (CI). HemoQuant values will be summarized using the sample median, minimum, 25th percentile, 75th percentile, and maximum. These measures will be reported overall, regardless of time after implantation, in order to provide an estimate of the frequency of gastrointestinal bleeding in VAD patients that will be able to be published quickly and raise awareness of this issue.
Measured: 1 year
Secondary outcomes (1)
Examine Behavior of Gastrointestinal Bleeding in VAD Patients By Estimating the Proportion of VAD Patients with an Abnormal HemoQuant Test Prior to Implantation
We will examine the behavior of gastrointestinal bleeding over time in VAD patients (as assessed by HemoQuant fecal occult blood test), by estimating the proportion of VAD patients with an abnormal HemoQuant test (and 95% CI) prior to implantation; at one week, one month, three months, six months and one year post implantation, and after explantation of the VAD.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2011 (estimated)
- Study start22 Jun 2011
- Primary completion22 Jun 2013
- Study completion22 Jun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal BleedingStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Other
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph L. Blackshear, Mayo Clinic
- Investigators
- Joseph L Blackshear, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01415869
- Sponsor's protocol ID
- 11-003334
- Status last verified
- May 2019
- First submitted
- 1 Aug 2011
- Last updated
- 20 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occult Gastrointestinal Bleeding in Non-pulsatile Left Ventricular Assist Device(VAD)Patients
- ClinicalTrials.gov ID
- NCT01415869
- Acronym / sponsor ID
- 11-003334
- Keywords
- Ventricular Assist Device, Gastrointestinal Bleeding, VAD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 22 Jun 2011 (actual)
- Primary completion
- 22 Jun 2013 (actual)
- Study completion
- 22 Jun 2013 (actual)
- First posted
- 12 Aug 2011 (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.
The purpose of this study is to estimate the proportion of Ventricular Assist Device (VAD) patients with abnormal gastrointestinal bleeding as assessed by HemoQuant fecal occult blood test. Also, in patients with gastrointestinal bleeding present, to summarize the extent of gastrointestinal bleeding; to examine the behavior of HemoQuant fecal occult blood test over time by estimating the proportion of VAD patients with a positive test prior to implantation; at one week, one month, three months, six months and one year post implantation, and after explantation of the VAD and to evaluate whether presence of any abnormal fecal HemoQuant test is predictive of a future major bleeding event.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cross Sectional | – | –Patients with implanted non-pulsatile ventricular assist devices of any type and at any time after implantation |
| Prospective | – | –Patients with usual VAD indications will be invited to participate, when, in the opinion of their treating physician a VAD will be highly likely within one month. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Group 1 Patients with implanted non-pulsatile ventricular assist devices of any type and at any time after implantation * Group 2 Patients with usual VAD indications will be invited to participate, when, in the opinion of their treating physician a VAD will be highly likely within one month.
Key inclusion criteria (2 listed)
- Group 1 - cross sectional study. Patients with implanted non-pulsatile ventricular assist devices of any type and at any time after implantation
- Group 2 - prospective study. Patients with usual VAD indications will be invited to participate, when, in the opinion of their treating physician a VAD will be highly likely within one month.
Key exclusion criteria (3 listed)
- Unwillingness to provide stool samples for study
- Unwillingness to be followed for study endpoints.
- Unwillingness to follow dietary restrictions necessary for accurate HemaQuant measurement
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
Proportion of VAD Patients with Gastrointestinal Bleeding as Assessed by HemoQuant Fecal Occult Blood Testing
Time frame: 1 year
We will estimate the proportion of VAD patients with gastrointestinal bleeding as assessed by HemoQuant fecal occult blood test along with an exact binomial 95% confidence interval (CI). HemoQuant values will be summarized using the sample median, minimum, 25th percentile, 75th percentile, and maximum. These measures will be reported overall, regardless of time after implantation, in order to provide an estimate of the frequency of gastrointestinal bleeding in VAD patients that will be able to be published quickly and raise awareness of this issue.
1 secondary outcome
Examine Behavior of Gastrointestinal Bleeding in VAD Patients By Estimating the Proportion of VAD Patients with an Abnormal HemoQuant Test Prior to Implantation
Time frame: 1 year
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 20 May 2019.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Joseph L Blackshear, MD principal investigator
Mayo Clinic
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 Gastrointestinal Bleeding and Complication of Internal Device, run by Mayo Clinic 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 2 inclusion and 3 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 20 May 2019. 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 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.
What does the primary outcome measure?
Proportion of VAD Patients with Gastrointestinal Bleeding as Assessed by HemoQuant Fecal Occult Blood Testing (time frame: 1 year). 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 20 May 2019; AzTrials last refreshed its copy on 1 Nov 2026.