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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Mayo Clinic
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01415869
First received: August 1, 2011
Last updated: April 16, 2014
Last verified: April 2014

August 1, 2011
April 16, 2014
July 2011
July 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01415869 on ClinicalTrials.gov Archive Site
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.
Same as current
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Occult Gastrointestinal Bleeding in Non-pulsatile Left Ventricular Assist Device(VAD)Patients
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; 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.

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Observational
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Non-Probability Sample
  • 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.
  • Gastrointestinal Bleeding
  • Complication of Internal Device
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
195
July 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Jonathan Wright 905-953-7521 Wright.Jonathan@mayo.edu
United States
 
NCT01415869
11-003334
No
Joseph L. Blackshear, M.D., Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Joseph L Blackshear, MD Mayo Clinic in Florida
Mayo Clinic
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP