Transfusion Requirements in GI Bleeding - Full Text View

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 IV

MedlinePlus related topics:

Blood Transfusion and Donation Cirrhosis Gastrointestinal Bleeding High Blood Pressure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Official Title:	Randomized and Controlled Clinical Trial of Transfusional Requirements in Patients With Acute Gastrointestinal Bleeding.

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
1: Active Comparator Regular transfusion	Procedure: red blood cell transfusion red blood cell transfusion
2: Active Comparator restricted transfusion	Procedure: red blood cell transfusion 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.
Pregnancy.
Negative of the patient to receive transfusions.
Negative of the patient to participate in the study.
Patiens with therapeutic restrictions (as terminally ill patients).
Previous recent surgery requiring transfusion.
Recent (less than 90 days) or unstable acute myocardic ischemia. Peripheral vasculopaty with secondary.
To have been included in this same study in the 30 previous days.

Contacts and Locations

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

Study ID Numbers:	EC/02/102/1729 HCSCSP
First Received:	December 21, 2006
Last Updated:	November 21, 2007
ClinicalTrials.gov Identifier:	NCT00414713
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

Study placed in the following topic categories:

Liver Diseases

Digestive System Diseases

Gastrointestinal Diseases

Fibrosis

Vascular Diseases

Gastrointestinal Hemorrhage

Hypertension, Portal

Liver Cirrhosis

Hemorrhage

Portal hypertension

Hypertension

Additional relevant MeSH terms:

Pathologic Processes

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Information provided by:	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:	NCT00414713