- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00519610
Assessing Outcome After H-graft Shunt Placement (PHTN)
August 14, 2012 updated by: Kenneth Luberice, University of South Florida
A Study Assessing Patient Outcomes After Placement of H-graft Portacaval Shunts for the Treatment of Portal Hypertension
The objective of this study is to evaluate the pre-operative symptoms and medical history of patients with portal hypertension who have undergone placement of H-graft portacaval shunts and correlate this with patient outcomes.
Study Overview
Detailed Description
Research data will be collected by accessing the Tampa General Hospital medical record charts as well as the Harbourside medical charts, and extracting the necessary research data.
The charts will be reviewed for the relevant medical information in order to assess outcomes in patients having H-graft shunts placed for the treatment of portal hypertension.
Study Type
Observational
Enrollment (Actual)
66
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Tampa, Florida, United States, 33606
- Tampa General Hospital/University of South Florida
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with portal hypertension
Description
Inclusion Criteria:
- Patients who have had H-graft shunts placed for the treatment of portal hypertension.
Exclusion Criteria:
- Patients under the age of 18 will not be included in this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
I
Patients will have charts reviewed for relevant medical information before and after surgery to assess patient outcome after placement of H-graft shunt for the treatment of portal hypertension.
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Patients' charts will be reviewed for relevant medical information.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The objective of this study is to evaluate the pre-operative symptoms and medical history of patients with portal hypertension who have undergone placement of H-graft portacaval shunts and correlate this with patient outcomes.
Time Frame: 5 years
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5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alexander S Rosemurgy, MD, University of South Florida
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2007
Study Completion (Actual)
July 1, 2010
Study Registration Dates
First Submitted
August 21, 2007
First Submitted That Met QC Criteria
August 21, 2007
First Posted (Estimate)
August 22, 2007
Study Record Updates
Last Update Posted (Estimate)
August 15, 2012
Last Update Submitted That Met QC Criteria
August 14, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 105982
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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