Cirrhosis Clinical Trial
Official title:
Randomized and Controlled Clinical Trial of Transfusional Requirements in Patients With Acute Gastrointestinal Bleeding.
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.
Status | Recruiting |
Enrollment | 860 |
Est. completion date | December 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Unidad de Sangrantes, HSCSP | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mortality at the 45th day | 45 days | ||
Secondary | Mortality at the 7th and 45th day | 45 days | ||
Secondary | Rebleeding | 45 days | ||
Secondary | Transfusion requirements | 45 days | ||
Secondary | Liquids requirements | 45 days | ||
Secondary | Portal pressure changes | 7 days | ||
Secondary | Complications | 45 days |
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