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Assessing Outcome After H-graft Shunt Placement (PHTN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kenneth Luberice, University of South Florida
ClinicalTrials.gov Identifier:
NCT00519610
First received: August 21, 2007
Last updated: August 14, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention
Portal Hypertension
 Other: Chart Review

Study Type: Observational
Official Title: A Study Assessing Patient Outcomes After Placement of H-graft Portacaval Shunts for the Treatment of Portal Hypertension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of South Florida:

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. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: July 2007
Study Completion Date: July 2010
Groups/Cohorts Assigned Interventions
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.
 Other: Chart Review
Patients' charts will be reviewed for relevant medical information.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with portal hypertension

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00519610

Locations
United States, Florida
Tampa General Hospital/University of South Florida
Tampa, Florida, United States, 33606
Sponsors and Collaborators
University of South Florida
Investigators
Principal Investigator: Alexander S Rosemurgy, MD University of South Florida
  More Information

No publications provided

Responsible Party: Kenneth Luberice, Clinical Research Coordinator, University of South Florida
ClinicalTrials.gov Identifier: NCT00519610     History of Changes
Other Study ID Numbers: 105982
Study First Received: August 21, 2007
Last Updated: August 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Florida:
portal hypertension, H-graft shunt

Additional relevant MeSH terms:
Hypertension
Hypertension, Portal
Vascular Diseases
 Cardiovascular Diseases
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 19, 2013