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:

* Female Subjects able to give consent
* Post partum patients
* Baseline Hbg\< /= 10
* Agree to practice birth control
* Demonstrate willingness to comply with protocol restrictions

Exclusion Criteria:

* Known hypersensitivity reaction to oral or IV iron (VIT-45)
* Documented history of discontinuing oral iron
* Significant bleeding
* History of anemia other that iron deficiency anemia
* Severe Psychiatric disorders
* Active severe infection
* Known Hepatitis B antigen or Hep C viral antibody or active hepatitis
* Known HIV antibody
* Received investigational product within 30 days
* Alcohol abuse
* Hemochromatosis or other iron storage disorder
B: Inclusion Criteria:

* Women older than 18 years
* 12-24 hours after delivery (vaginal or caesarean section)
* Patients are in a clinical obstetric setting
* Blood loss of more than 1000 mL or Hb decrease ≥ 1,9 g/dL
* Hb value between 4.8 g/dL and 7.9 g/dL
* Working knowledge of the national language
* Written consent for participating this study (informed consent)

Exclusion Criteria:

* Patients with severe preeclampsia/ HELLP syndrome
* RBC transfusion during or after delivery but before t=0
* Patients with malignancy
* Patients with severe congenital haemolytic disease, like thalassemia or sickle cell disease
* Patients with compromised immunological status, congenital or acquired by medical treatment or infectious disease (eg. HIV)
* Severe active infectious disease at the time of proposed inclusion
* Severe cardiac, pulmonary, neurological, metabolic or psychiatric co- morbidity (ASA II/III) at the time of proposed inclusion
* Severe physical complaints (tachycardia of more than 100 bpm, dyspnoea, syncope, heart problems) at the time of intended inclusion
* Peripartum death of the newborn, or the newborn being in critical condition on neonatal intensive care
C: 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.
D: Inclusion Criteria:

1. Women with PPH ≥ 700 and ≤ 1000 mL or PPH \> 1000 mL and Hb \> 6.5 g/dL (4.0 mmol/L) measured \> 12 hours after delivery
2. Willingness to participate and signed the informed consent form

Exclusion Criteria:

1. Women aged \< 18 years
2. Multiple births
3. Peripartum RBC transfusion
4. Known iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
5. Known hypersensitivity to parenteral iron or any excipients in the investigational drug products
6. Women with a history of active asthma within the last 5 years or a history of multiple allergies
7. Known decompensated liver cirrhosis and active hepatitis
8. Women with HELLP (Haemolysis Elevated Liver enzymes Low Platelet count) syndrome (defined according to "Dansk Selskab for Obstetrik og Gynækologi guidelines")
9. Active acute infection assessed by clinical judgement
10. Rheumatoid arthritis with symptoms or signs of active joint inflammation
11. History of anaemia caused by e. g. thalassemia, hypersplenism or haemolytic anaemia (known haematologic disorder other than iron deficiency)
12. Not able to read, speak and understand the Danish language
13. Participation in any other clinical study where the study drug has not passed 5 half-lives prior to the baseline
14. Any other medical condition that, in the opinion of the Investigator, may cause the patient to be unsuitable for completion of the study or place the patient at potential risk from being in the study. For example, a malignancy, uncontrolled hypertension, unstable ischaemic heart disease or uncontrolled diabetes mellitus

Answer: C