Transfusion Requirements in Gastrointestinal (GI) Bleeding

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT00414713
First received: December 21, 2006
Last updated: December 28, 2010
Last verified: December 2010
  Purpose

Recently it has been suggested that a restrictive transfusion of units of Red Cells (URC) may improve the outcome of ICU patients with anemia. Furthermore, it has been suggested that the transfusion of URC may be deleterious for the hemostatic process of bleeding lesions, which suggest that a restrictive transfusion may be valuable in patients which gastrointestinal bleeding. Transfusion of URC may also increase portal pressure which may be detrimental to control acute portal hypertensive bleeding.

The aim of the present study is to assess whether a restrictive transfusions may improve the outcome of patients with acute nonvariceal gastrointestinal bleeding, and also whether such a restrictive strategy may improve the outcome of bleeding episodes related with portal hypertension.

The study will be carried out with a prospective, randomized and controlled design comparing the restrictive transfusion strategy with the usual nonrestrictive transfusional strategy. Overall 860 patients will be included; 430 in each group.

The main outcome measure will be survival. All deaths occurred within the 30 days after admission, will be considered. Secondary outcomes will include rebleeding and complications related to treatment, and related to the bleeding episode itself. Portal pressure will be measured to assess the influence of the transfusions strategy on fluctuations of this parameter, and the relationship with the clinical course of bleeding episode.

The study will be performed at the Bleeding Unit of our hospital during a period of 3 years.


Condition Intervention Phase
Upper Gastrointestinal Bleeding
Cirrhosis
Portal Hypertension
Procedure: red blood cell transfusion
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized and Controlled Clinical Trial of Transfusional Requirements in Patients With Acute Gastrointestinal Bleeding.

Resource links provided by NLM:


Further study details as provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

Primary Outcome Measures:
  • Mortality at the 45th day [ Time Frame: 45 days ]

Secondary Outcome Measures:
  • Mortality at the 7th and 45th day [ Time Frame: 45 days ]
  • Rebleeding [ Time Frame: 45 days ]
  • Transfusion requirements [ Time Frame: 45 days ]
  • Liquids requirements [ Time Frame: 45 days ]
  • Portal pressure changes [ Time Frame: 7 days ]
  • Complications [ Time Frame: 45 days ]

Estimated Enrollment: 860
Study Start Date: October 2002
Estimated Study Completion Date: December 2007
Arms Assigned Interventions
Active Comparator: 1
Regular transfusion
Procedure: red blood cell transfusion
red blood cell transfusion
Other Name: red blood cell transfusion
Active Comparator: 2
Restricted transfusion
Procedure: red blood cell transfusion
red blood cell transfusion
Other Name: red blood cell transfusion

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients with acute upper GI hemorrhage who do not have any criterion of exclusion.

Exclusion Criteria:

  • < 18 years old.
  • Pregnancy.
  • Negative of the patient to receive transfusions.
  • Negative of the patient to participate in the study.
  • Patients with therapeutic restrictions (as terminally ill patients).
  • Previous recent surgery requiring transfusion.
  • Recent (less than 90 days) or unstable acute myocardic ischemia. Peripheral vasculopathy with secondary.
  • To have been included in this same study in the 30 previous days.
  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: NCT00414713

Contacts
Contact: Càndid - Villanueva, DR. +34620955006 cvillanueva@santpau.es

Locations
Spain
Unidad de Sangrantes, HSCSP Recruiting
Barcelona, Spain, 08025
Contact: Càndid Villanueva, DR    +34620955006    cvillanueva@santpau.es   
Principal Investigator: Càndid Villanueva, DR         
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators
Principal Investigator: Càndid Villanueva, DR HSCSP
  More Information

No publications provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00414713     History of Changes
Other Study ID Numbers: EC/02/102/1729 HCSCSP
Study First Received: December 21, 2006
Last Updated: December 28, 2010
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
Upper GI bleeding
Cirrhosis
Portal hypertension
Non-variceal bleeding
Transfusion

Additional relevant MeSH terms:
Gastrointestinal Hemorrhage
Hemorrhage
Hypertension
Hypertension, Portal
Liver Cirrhosis
Fibrosis
Gastrointestinal Diseases
Digestive System Diseases
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Liver Diseases

ClinicalTrials.gov processed this record on July 22, 2014