Transfusion Requirements in Gastrointestinal (GI) Bleeding

NCT00414713 | Unknown Phase 4 DMC

• 1 other identifier: EC/02/102/1729 HCSCSP
• Study Type: interventional
• Target: 860
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Upper Gastrointestinal Bleeding; Cirrhosis; Portal Hypertension

Keywords

Upper GI bleeding; Cirrhosis; Portal hypertension; Non-variceal bleeding; Transfusion

Outcome Measures

Primary Outcomes (1)

• Mortality at the 45th day

  45 days

Secondary Outcomes (6)

• Mortality at the 7th and 45th day

  45 days

• Rebleeding

  45 days

• Transfusion requirements

  45 days

• Liquids requirements

  45 days

• Portal pressure changes

  7 days

Study Arms (2)

1

ACTIVE COMPARATOR

Regular transfusion

Procedure: red blood cell transfusion

2

ACTIVE COMPARATOR

Restricted transfusion

Procedure: red blood cell transfusion

Interventions

red blood cell transfusion PROCEDURE

red blood cell transfusion

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• \< 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.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead

Study Sites (1)

Unidad de Sangrantes, HSCSP

Barcelona, Barcelona, 08025, Spain

RECRUITING

Related Publications (3)

• Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.

  PMID: 41114449 DERIVED

• Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.

  PMID: 34932836 DERIVED

• Villanueva C, Colomo A, Bosch A, Concepcion M, Hernandez-Gea V, Aracil C, Graupera I, Poca M, Alvarez-Urturi C, Gordillo J, Guarner-Argente C, Santalo M, Muniz E, Guarner C. Transfusion strategies for acute upper gastrointestinal bleeding. N Engl J Med. 2013 Jan 3;368(1):11-21. doi: 10.1056/NEJMoa1211801.

  PMID: 23281973 DERIVED

MeSH Terms

Conditions

Gastrointestinal Hemorrhage; Fibrosis; Hypertension, Portal

Interventions

Erythrocyte Transfusion

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases

Intervention Hierarchy (Ancestors)

Blood Component Transfusion; Blood Transfusion; Biological Therapy; Therapeutics

Study Officials

• Càndid Villanueva, DR

  HSCSP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Càndid - Villanueva, DR.

CONTACT

+34620955006; cvillanueva@santpau.es

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 21, 2006
• First Posted: December 22, 2006
• Study Start: October 1, 2002
• Study Completion: December 1, 2007
• Last Updated: December 29, 2010

Record last verified: 2010-12

Locations

ES (1)