Occult Gastrointestinal Bleeding in Non-pulsatile Left Ventricular Assist Device(VAD)Patients
This study is currently recruiting participants.
Verified February 2013 by Mayo Clinic
Sponsor:
Mayo Clinic
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01415869
First received: August 1, 2011
Last updated: February 27, 2013
Last verified: February 2013
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Purpose
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.
| Condition |
|---|
|
Gastrointestinal Bleeding Complication of Internal Device |
| Study Type: | Observational |
| Official Title: | Occult Gastrointestinal Bleeding in Non-pulsatile Left Ventricular Assist Device(VAD)Patients |
Resource links provided by NLM:
Further study details as provided by Mayo Clinic:
Primary Outcome Measures:
- Proportion of VAD Patients with Gastrointestinal Bleeding as Assessed by HemoQuant Fecal Occult Blood Testing [ Time Frame: 1 year ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 195 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Unwillingness to provide stool samples for study
- Unwillingness to be followed for study endpoints.
- Unwillingness to follow dietary restrictions necessary for accurate HemaQuant measurement
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01415869
Contacts
| Contact: Judith L Weddington | 905-953-9700 | weddington.judith@mayo.edu |
Locations
| United States, Florida | |
| Mayo Clinic | Recruiting |
| Jacksonville, Florida, United States, 32224 | |
| Contact: Judith L Weddington 904-953-9700 weddington.judith@mayo.edu | |
| Principal Investigator: Joseph L Blackshear, MD | |
| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Judith L Weddington 904-953-9700 weddington.judith@mayo.edu | |
| Principal Investigator: Sheri Crow, MD | |
Sponsors and Collaborators
Mayo Clinic
Investigators
| Principal Investigator: | Joseph L Blackshear, MD | Mayo Clinic in Florida |
More Information
No publications provided
| Responsible Party: | Joseph L. Blackshear, M.D., Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT01415869 History of Changes |
| Other Study ID Numbers: | 11-003334 |
| Study First Received: | August 1, 2011 |
| Last Updated: | February 27, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Mayo Clinic:
|
Ventricular Assist Device Gastrointestinal Bleeding VAD |
Additional relevant MeSH terms:
|
Gastrointestinal Hemorrhage Hemorrhage Gastrointestinal Diseases Digestive System Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013