Please select the arm or intervention descriptions that belong 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: Arm Label: Allowed drop in hemoglobin to 4.5-5.5 mmol/L; Type: ACTIVE_COMPARATOR; Interventions: Other: Allowed drop in hemoglobin to 4.5-5.5 mmol/L | Arm Label: Allowed drop in hemoglobin to 5.6-6.5 mmol/L; Type: EXPERIMENTAL; Interventions: Other: Allowed drop in hemoglobin to level between 5.6-6.5 mmol/L | Intervention Type: OTHER; Name: Allowed drop in hemoglobin to 4.5-5.5 mmol/L; Assigned to Arm(s): Allowed drop in hemoglobin to 4.5-5.5 mmol/L | Intervention Type: OTHER; Name: Allowed drop in hemoglobin to level between 5.6-6.5 mmol/L; Assigned to Arm(s): Allowed drop in hemoglobin to 5.6-6.5 mmol/L
B: Arm Label: Epo1 and TT10; Type: ACTIVE_COMPARATOR; Interventions: Drug: recombinant human erythropoietin, rhEpo | Arm Label: Epo1 and TT7; Type: ACTIVE_COMPARATOR; Interventions: Drug: recombinant human erythropoietin, rhEpo | Arm Label: Epo2 and TT10; Type: ACTIVE_COMPARATOR; Interventions: Drug: recombinant human erythropoietin, rhEpo | Arm Label: Epo2 and TT7; Type: ACTIVE_COMPARATOR; Interventions: Drug: recombinant human erythropoietin, rhEpo | Arm Label: Placebo and TT10; Type: PLACEBO_COMPARATOR; Interventions: Other: placebo | Arm Label: Placebo and TT7; Type: PLACEBO_COMPARATOR; Interventions: Other: placebo | Intervention Type: DRUG; Name: recombinant human erythropoietin, rhEpo; Assigned to Arm(s): Epo1 and TT10, Epo1 and TT7, Epo2 and TT10, Epo2 and TT7 | Intervention Type: OTHER; Name: placebo; Assigned to Arm(s): Placebo and TT10, Placebo and TT7
C: Arm Label: Restrictive RBC Transfusion Group; Type: EXPERIMENTAL; Interventions: Biological: Restrictive RBC Transfusion | Arm Label: Liberal RBC Transfusion Group; Type: EXPERIMENTAL; Interventions: Biological: Liberal RBC Transfusion | Intervention Type: BIOLOGICAL; Name: Restrictive RBC Transfusion; Assigned to Arm(s): Restrictive RBC Transfusion Group | Intervention Type: BIOLOGICAL; Name: Liberal RBC Transfusion; Assigned to Arm(s): Liberal RBC Transfusion Group
D: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Procedure: red blood cell transfusion | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Procedure: red blood cell transfusion | Intervention Type: PROCEDURE; Name: red blood cell transfusion; Assigned to Arm(s): 1, 2

Answer: D