Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized and Controlled Clinical Trial of Transfusional Requirements in Patients With Acute Gastrointestinal Bleeding.
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.


Options:
A: Inclusion Criteria:

* 18 years or older
* Patients undergoing replacement of hip arthroplasty
* Be legally competent
* Read and understand Danish

Exclusion Criteria:

* Present malignant disease
* Known heart disease with functionality equivalent to NYHA II or CCS II or worse
B: Inclusion Criteria:

* Blunt trauma mechanism of brain injury
* Glasgow Coma Score - motor component ≤ 5 (not following commands) on the post-resuscitation neurologic exam
* Available for enrollment and administration of study drug within 6 hours of injury

Exclusion Criteria:

* Penetrating trauma (i.e. gun shot wounds)
* Glasgow Coma Score = 3 and bilateral fixed and dilated pupils
* Abbreviated Injury Scale score \> 5 for any body part except brain
* Severe pre-existing chronic disease
* Uncontrolled hypertension, defined as mean arterial pressure \> 130mmHg despite antihypertensive treatment
* Known hypersensitivity to mammalian cell-derived products or human albumin
* Currently taking anticoagulants
C: Inclusion Criteria:

* The patient remains in the ICU after 96 hours (4 days) or more following ICU admission
* The patient has required mechanical ventilation via an endotracheal tube or tracheostomy tube for 96 hours or more
* The patient is expected to require ≥24 hours of further mechanical ventilation at the time of assessment
* The patient is aged ≥55 years of age
* The patient has a Hb value of 90g/L or less at the time of assessment

Exclusion Criteria:

* Patient with active bleeding at the time of screening
* Patient with traumatic brain injury as presenting diagnosis
* Patient with intracranial haemorrhage as presenting diagnosis
* Patient not expected to survive the next 48 hours at the time of assessment.
* Patient objects to RBC transfusion
* Patient receiving concurrent treatment with erythropoietin or similar erythropoietic agent
* Follow up is not feasible
* Already enrolled in another RCT with similar clinical endpoints
D: 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.

Answer: D