Upper Gastrointestinal BleedingPhase 4NCT00414713
Transfusion Requirements in Gastrointestinal (GI) Bleeding
A Phase 4 study testing red blood cell transfusion in people with Upper Gastrointestinal Bleeding and Cirrhosis, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Gastrointestinal Bleeding, Cirrhosis, Portal Hypertension
- What is being tested?
- red blood cell transfusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 860 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2002to Dec 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with acute upper GI hemorrhage who do not have any criterion of exclusion.
Who cannot join
- < 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Unidad de Sangrantes, HSCSP
Barcelona, Barcelona, 08025
Càndid Villanueva, DR, +34620955006, cvillanueva@santpau.es
Càndid Villanueva, DR
About this study
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.
Read more
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.
Read the detailed description
HYPOTHESIS
At the present time there does not exist established criteria to decide when it is necessary a blood transfusion in a patient with digestive hemorrhage, neither which should be the red cells concentrates (RBC) amount that the most of the patients will need.
In clinical studies made in critical patients undergoing a by-pass coronary surgery, the strategy of restrictive transfusion showed results similar to the one obtained with more liberal strategies, even with an improvement of the survival and a smaller rate of complications related to transfusion.
In animal models of GI bleeding (and also in human studies in the traumatic hemorrhage), precocious or vigorous transfusion made hemostasia more difficult. Also an increase in the rate of rebleeding has been observed, suggesting that arterial hypotension combined with hypovolemia aid hemostasia, stabilize the clot. It leads to diminish by itself the rebleeding rate.
In the same way, in patients with portal hypertension associated hemorrhage, aggressive replacement of volemia causes increases on the portal pressure, and that could lead in a condition of bigger difficulty for the control of the hemorrhage and greater rate of recidiva.
On the other hand, potential complications associated with the transfusion would be seen potentially reduced.
Our randomized prospective study tries to demonstrate that the use of a restrictive strategy in the sanguineous transfusion in patients with acute GI upper bleeding can be at least as beneficial than the habitually used.
Moreover, restricted transfusion in these patients could improve short term survival, as well as a smaller rate transfusion-related or rebleeding.
In portal hypertension related hemorrhage, restricted transfusion could avoid fluctuations of portal pressure caused by transfusion during the acute phase of hemorrhage, which could favor hemostasia in these patients.
OBJECTIVES
The main objective is to evaluate if restrictive transfusion criterion in patients with acute upper GI hemorrhage can maintain the rates of survival obtained using habitual transfusion criteria, or to even improve them.
The more important secondary targets consist in evaluating if these restrictive transfusional parameters are also accompanied by a better control of the hemorrhage, and also to evaluate if this is accompanied by a smaller rate of complications.
Other additional objectives would be:
- Effect on changes in portal pressure and its correlation with the clinical evolution.
- Hospital stay and estimation of economic cost.
STUDY DESIGN
Ours is a prospective, randomized and controlled study, in which patients with acute upper GI bleeding will be randomized into two groups of transfusional RBC treatment with:
Group 1 (of restricted transfusion), that constitutes the training group: they will receive UCH transfusion when the hemoglobin descends below 70 G/L, to maintain values of hemoglobin of 70 to 90 G/L.
Group 2 (of habitual transfusion), that constitutes the group control: they will receive transfusion according to habitual practice, when the hemoglobin descends below 90 G/L, to maintain values of hemoglobin of 90 to 110 G/L.
Randomization will be made by means of a closed opaque envelope that will contain the treatment option that will have been obtained by means of a listing of random numbers generated by computer.
The patients will be randomized as soon as the inclusion criteria/exclusion has been verified.
Randomization will be stratified according to the origin of the hemorrhage (related to portal hypertension or not).
NUMBER OF PREDICTED SUBJECTS AND JUSTIFICATION:
430 patients in every group will be required (860 altogether), to objective a mortality reduction of 5%, with a global expected mortality secondary to GI bleeding at the control group of 10%, with a type I error of 5% and a type II error of 20%.
280 patients in each group will be required (560 altogether) to objective a difference of 6%, with the detailed parameters.
An expected period of 3 years to include this
- Being tested
- red blood cell transfusion
- Keywords
- Upper GI bleeding, Cirrhosis, Portal hypertension, Non-variceal bleeding, Transfusion
- Medical subject headings
- Gastrointestinal Hemorrhage, Fibrosis, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
red blood cell transfusionProcedure or surgery
red blood cell transfusion
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Regular transfusion Receives: Procedure: red blood cell transfusion |
| 2 | Active comparator | Restricted transfusion Receives: Procedure: red blood cell transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality at the 45th day
Measured: 45 days
Secondary outcomes (6)
Mortality at the 7th and 45th day
Measured: 45 days
Rebleeding
Measured: 45 days
Transfusion requirements
Measured: 45 days
Liquids requirements
Measured: 45 days
Portal pressure changes
Measured: 7 days
Complications
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2006 (estimated)
- Study startOct 2002
- Study completionDec 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Upper Gastrointestinal BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 860 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Sponsor type
- University, hospital or other
- Investigators
- Càndid Villanueva, DR, Principal investigator, HSCSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00414713
- Sponsor's protocol ID
- EC/02/102/1729 HCSCSP
- Status last verified
- Dec 2010
- First submitted
- 21 Dec 2006
- Last updated
- 29 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 41114449Carson 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.
PubMed 34932836Villanueva 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.
PubMed 23281973
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized and Controlled Clinical Trial of Transfusional Requirements in Patients With Acute Gastrointestinal Bleeding.
- ClinicalTrials.gov ID
- NCT00414713
- Acronym / sponsor ID
- EC/02/102/1729 HCSCSP
- Keywords
- Upper GI bleeding, Cirrhosis, Portal hypertension, Non-variceal bleeding, Transfusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 860 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Oct 2002
- Study completion
- Dec 2007 (estimated)
- First posted
- 22 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
HYPOTHESIS
At the present time there does not exist established criteria to decide when it is necessary a blood transfusion in a patient with digestive hemorrhage, neither which should be the red cells concentrates (RBC) amount that the most of the patients will need.
In clinical studies made in critical patients undergoing a by-pass coronary surgery, the strategy of restrictive transfusion showed results similar to the one obtained with more liberal strategies, even with an improvement of the survival and a smaller rate of complications related to transfusion.
In animal models of GI bleeding (and also in human studies in the traumatic hemorrhage), precocious or vigorous transfusion made hemostasia more difficult. Also an increase in the rate of rebleeding has been observed, suggesting that arterial hypotension combined with hypovolemia aid hemostasia, stabilize the clot. It leads to diminish by itself the rebleeding rate.
In the same way, in patients with portal hypertension associated hemorrhage, aggressive replacement of volemia causes increases on the portal pressure, and that could lead in a condition of bigger difficulty for the control of the hemorrhage and greater rate of recidiva.
On the other hand, potential complications associated with the transfusion would be seen potentially reduced.
Our randomized prospective study tries to demonstrate that the use of a restrictive strategy in the sanguineous transfusion in patients with acute GI upper bleeding can be at least as beneficial than the habitually used.
Moreover, restricted transfusion in these patients could improve short term survival, as well as a smaller rate transfusion-related or rebleeding.
In portal hypertension related hemorrhage, restricted transfusion could avoid fluctuations of portal pressure caused by transfusion during the acute phase of hemorrhage, which could favor hemostasia in these patients.
OBJECTIVES
The main objective is to evaluate if restrictive transfusion criterion in patients with acute upper GI hemorrhage can maintain the rates of survival obtained using habitual transfusion criteria, or to even improve them.
The more important secondary targets consist in evaluating if these restrictive transfusional parameters are also accompanied by a better control of the hemorrhage, and also to evaluate if this is accompanied by a smaller rate of complications.
Other additional objectives would be:
- Effect on changes in portal pressure and its correlation with the clinical evolution.
- Hospital stay and estimation of economic cost.
STUDY DESIGN
Ours is a prospective, randomized and controlled study, in which patients with acute upper GI bleeding will be randomized into two groups of transfusional RBC treatment with:
Group 1 (of restricted transfusion), that constitutes the training group: they will receive UCH transfusion when the hemoglobin descends below 70 G/L, to maintain values of hemoglobin of 70 to 90 G/L.
Group 2 (of habitual transfusion), that constitutes the group control: they will receive transfusion according to habitual practice, when the hemoglobin descends below 90 G/L, to maintain values of hemoglobin of 90 to 110 G/L.
Randomization will be made by means of a closed opaque envelope that will contain the treatment option that will have been obtained by means of a listing of random numbers generated by computer.
The patients will be randomized as soon as the inclusion criteria/exclusion has been verified.
Randomization will be stratified according to the origin of the hemorrhage (related to portal hypertension or not).
NUMBER OF PREDICTED SUBJECTS AND JUSTIFICATION:
430 patients in every group will be required (860 altogether), to objective a mortality reduction of 5%, with a global expected mortality secondary to GI bleeding at the control group of 10%, with a type I error of 5% and a type II error of 20%.
280 patients in each group will be required (560 altogether) to objective a difference of 6%, with the detailed parameters.
An expected period of 3 years to include this
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: red blood cell transfusionRegular transfusion |
| 2 | Active comparator | Procedure: red blood cell transfusionRestricted transfusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with acute upper GI hemorrhage who do not have any criterion of exclusion.
Key exclusion criteria (8 listed)
- < 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| red blood cell transfusionred blood cell transfusion | Procedure or surgery | 1, 2 |
Primary outcome
Mortality at the 45th day
Time frame: 45 days
6 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2010.
- Derived from this study: PubMed 41114449Carson 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.
- Derived from this study: PubMed 34932836Carson 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.
- Derived from this study: PubMed 23281973Villanueva 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Càndid Villanueva, DR principal investigator
HSCSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing red blood cell transfusion in people with Upper Gastrointestinal Bleeding and Cirrhosis, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Càndid - Villanueva, DR. (+34620955006, cvillanueva@santpau.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality at the 45th day (time frame: 45 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00414713, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2010.