NCT00519610

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 22, 2007

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

August 15, 2012

Status Verified

August 1, 2012

First QC Date

August 21, 2007

Last Update Submit

August 14, 2012

Conditions

Portal Hypertension

Keywords

portal hypertension, H-graft shunt

Outcome Measures

Primary Outcomes (1)

  • 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.

    5 years

Study Arms (1)

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

Interventions

Chart ReviewOTHER

Patients' charts will be reviewed for relevant medical information.

I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with portal hypertension

You may qualify if:

  • Patients who have had H-graft shunts placed for the treatment of portal hypertension.

You may not qualify if:

  • Patients under the age of 18 will not be included in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampa General Hospital/University of South Florida

Tampa, Florida, 33606, United States

Location

MeSH Terms

Conditions

Hypertension, Portal

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Study Officials

  • Alexander S Rosemurgy, MD

    University of South Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Research Coordinator

Study Record Dates

First Submitted

August 21, 2007

First Posted

August 22, 2007

Study Start

July 1, 2007

Study Completion

July 1, 2010

Last Updated

August 15, 2012

Record last verified: 2012-08

Locations

US(1)