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NCT01415869 · ClinicalTrials.gov registry record
Occult Gastrointestinal Bleeding in Non-pulsatile Left Ventricular Assist Device(VAD)Patients
A clinical trial, sponsored by Mayo Clinic.
- Completed
- Registry status
- 38
- Enrollment target
NCT01415869: Completed study, sponsored by Mayo Clinic.
NCT01415869 is a clinical trial that has completed, run by Mayo Clinic. The registered enrollment target is 38 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01415869 has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- 38 participants
- Enrollment target
Study 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. 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.
Primary Outcome
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 b
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2011-06-22 |
| Est. Completion | 2013-06-22 |
What the finished NCT01415869 record still lists
NCT01415869 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 38 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01415869 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01415869 about?
NCT01415869 is a clinical study titled "Occult Gastrointestinal Bleeding in Non-pulsatile Left Ventricular Assist Device(VAD)Patients". 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...
What is the current status of trial NCT01415869?
This trial is currently completed. The enrollment target is 38 participants. The study started on 2011-06-22. Estimated completion is 2013-06-22.
Who is sponsoring clinical trial NCT01415869?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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