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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-22

Study Completion Date

2013-06-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Screening for Occult Malignancy in Patients with Unprovoked Venous Thromboembolism

NCT04304651

Embolism and Thrombosis

RECRUITING NA

Non-Contrast 4DCT to Detect Pulmonary Thromboembolic Events

NCT03183063

Pulmonary Thromboembolisms Pulmonary Embolism

COMPLETED NA

Development of a Device for Evaluating Primary Hemostasis Under Whole Blood Flow Conditions

NCT03773159

Von Willebrand Diseases Major Constitutional Thrombopathy Patient on Antiplatelet Drugs

RECRUITING

Screening for Occult Malignancy in Patients With Idiopathic Venous Thromboembolism

NCT00773448

Venous Thromboembolism Deep Vein Thrombosis Pulmonary Embolism

COMPLETED NA

EVOLUTION OF D-DIMER AS A MARKER OF BLEEDING RISK ON ECMO

NCT07039513

ECMO Mplementation of a Veno-venous VV or Veno-arterial VA INTENSIVE CARE

NOT_YET_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastrointestinal Bleeding Complication of Internal Device

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cross Sectional

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

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No