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

Mayo Clinic

Status: Completed

Conditions: Complication of Internal Device; Gastrointestinal Bleeding

Study type: Observational

Funder types: Other

Identifiers

NCT01415869

11-003334

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

38 participants in 2 patient groups

Cross Sectional

Description:

Patients with implanted non-pulsatile ventricular assist devices of any type and at any time after implantation

Prospective

Description:

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.