Back to resultsAssessing Outcome After H-graft Shunt Placement (PHTN)
Primary Purpose
Portal Hypertension
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Chart Review
Sponsored by
About this trial
This is an observational trial for Portal Hypertension focused on measuring portal hypertension, H-graft shunt
Eligibility Criteria
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.
Sites / Locations
- Tampa General Hospital/University of South Florida
Arms of the Study
Arm 1
Arm Type
Arm Label
I
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00519610
First Posted
August 21, 2007
Last Updated
August 14, 2012
Sponsor
University of South Florida
1. Study Identification
Unique Protocol Identification Number
NCT00519610
Brief Title
Assessing Outcome After H-graft Shunt Placement
Acronym
PHTN
Official Title
A Study Assessing Patient Outcomes After Placement of H-graft Portacaval Shunts for the Treatment of Portal Hypertension
Study Type
Observational
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Florida
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Portal Hypertension
Keywords
portal hypertension, H-graft shunt
7. Study Design
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
I
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Chart Review
Intervention Description
Patients' charts will be reviewed for relevant medical information.
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Population Description
Patients with portal hypertension
Sampling Method
Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander S Rosemurgy, MD
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tampa General Hospital/University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Assessing Outcome After H-graft Shunt Placement
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