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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01415869

Contacts
Contact: Jonathan Wright 905-953-7521 Wright.Jonathan@mayo.edu

Locations
United States, Florida
Mayo Clinic Recruiting
Jacksonville, Florida, United States, 32224
Contact: Jonathan J Wright    905-953-7521    wright.jonathan@mayo.edu   
Principal Investigator: Joseph L Blackshear, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jonathan J Wright    905-953-7521    wright.jonathan@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: April 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Ventricular Assist Device
Gastrointestinal Bleeding
VAD

Additional relevant MeSH terms:
Hemorrhage
Gastrointestinal Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 18, 2014