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

Gastrointestinal Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01415869
• Other study ID #: 11-003334
• Status: Completed
• Start date: June 22, 2011
• Est. completion date: June 22, 2013

Study information

• Verified date: May 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 22, 2013
• Est. primary completion date: June 22, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Complication of Internal Device
• Gastrointestinal Bleeding
• Gastrointestinal Hemorrhage
• Hemorrhage

Locations

Country	Name	City	State
United States	Mayo Clinic	Jacksonville	Florida
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Secondary	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.	1 year

External Links

•   Mayo Clinic Clinical Trials