Occult Gastrointestinal Bleeding in Non-pulsatile Left Ventricular Assist Device(VAD)Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01415869

Enrollment

Registered

2011-08-12

Start date

2011-06-22

Completion date

2013-06-22

Last updated

2019-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complication of Internal Device, Gastrointestinal Bleeding

Keywords

Ventricular Assist Device, Gastrointestinal Bleeding, VAD

Brief 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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Proportion of VAD Patients with Gastrointestinal Bleeding as Assessed by HemoQuant Fecal Occult Blood Testing	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.

Secondary

Measure	Time frame	Description
Examine Behavior of Gastrointestinal Bleeding in VAD Patients By Estimating the Proportion of VAD Patients with an Abnormal HemoQuant Test Prior to Implantation	1 year	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.

Countries

United States

Outcome results