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TIPS Versus Portacaval Shunt for Acute Bleeding Varices in Cirrhosis

This study has been completed.
Sponsor:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00734227
First received: August 13, 2008
Last updated: NA
Last verified: July 2008
History: No changes posted
  Purpose

In unselected cirrhotic patients with acute portal hypertension-related bleeding to compare the effectiveness in control of bleeding, mortality rate, duration of life, quality of life, and economic costs of two widely used treatment measures: (1) emergency transjugular intrahepatic portal-systemic shunt (TIPS), and (2) emergency portacaval shunt.


Condition Intervention
Bleeding
Procedure: Emergency portacaval shunt
Other: Emergency TIPS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: TIPS Versus Portacaval Shunt for Acute Bleeding Varices in Cirrhosis

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Survival [ Time Frame: 10 years ]

Secondary Outcome Measures:
  • Control of bleeding and quality of life [ Time Frame: 10 years ]

Enrollment: 153
Study Start Date: July 1996
Study Completion Date: July 2006
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A

Randomization: By the blind card method to TIPS or emergency portacaval shunt. Diagnostic Workup: Completed within 6hr. Rapidity of Therapy: Within 24 hr. Failure of Therapy: Bleeding requiring >6u PRBC in first 7 days, or 8 units PRBC during 12 months.

Rescue Crossover Therapy: When primary therapy has failed. Followup: Lifelong data collection on line, analysis by biostatistician Florin Vaida, PhD. External Advisory, Data Monitoring and Safety Committee by 3 senior academicians.

Procedure: Emergency portacaval shunt.

Procedure: Emergency portacaval shunt
Active Comparator: B
Procedure: Emergency TIPS.
Other: Emergency TIPS

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients with UGI bleeding who are shown to have the findings of cirrhosis and esophagogastric varices or portal hypertensive gastropathy and require 2 or more units of blood transfusion will be included.

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00734227

Locations
United States, California
UCSD Medical Center
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Marshall J. Orloff, M.D. UCSD Medical Center
  More Information

No publications provided by University of California, San Diego

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marshall J. Orloff, M.D., University of California, San Diego
ClinicalTrials.gov Identifier: NCT00734227     History of Changes
Other Study ID Numbers: TvSSTUDY
Study First Received: August 13, 2008
Last Updated: August 13, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
Survival and control of hemorrhage

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014