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:

* Males and females older than 18 years of age who have postoperative Hb \< 10gm/dl within 15 days after the index operation
* Patients who undergo an operation in either one of the three following categories:

  * Veterans who undergo PAD - related operations including but not limited to the following:

    * aortobifemoral or aortobiiliac bypass
    * open abdominal aortic aneurysm repair with simultaneous repair of aortoiliac occlusive disease
    * visceral bypass
    * iliofemoral bypass
    * femoral bypass or endarterectomy
    * infrainguinal bypass
    * thromboembolectomy
    * supra-aortic trunk bypass or endarterectomy
    * carotid endarterectomy
    * major lower extremity amputations (transfemoral, through the knee, or transtibial)
  * Veterans with past medical history of ischemic stroke or IHD or PAD who undergo the following general surgery procedures, defined as:

    * known prior MI
    * ECG findings consistent with prior MI
    * prior percutaneous coronary intervention
    * prior coronary artery bypass surgery
    * history of angina for which the patient is currently receiving treatment
    * stress test indicating myocardial ischemia
    * who undergo the following General Surgery operations:

      * Open cholecystectomy or other complex biliary reconstruction
      * such as open common bile duct exploration for stones
      * reconstruction as part of oncologic operations such as palliative pancreatic cancer procedures)
    * small bowel resection
    * pancreatectomy
    * colon resection
    * rectal resection
    * splenectomy
    * transhiatal esophagectomy
    * liver resection
    * gastric resection
    * open ventral hernia repair
    * Colostomies (reversals and takedowns)
    * Intestinal anastomosis takedowns and revisions
    * Gastric bypass
    * Adrenalectomies
    * Major diaphragmatic hiatal hernia repairs
  * Veterans with past medical history of ischemic stroke or IHD or PAD who undergo the following Vascular Surgery operations:

    * Open aneurysm repair, including but not limited to:

      * carotid
      * subclavian
      * abdominal aortic
      * iliac
      * femoral
      * popliteal aneurysms
    * and complex endovascular aneurysm repair, defined as:

      * fenestrated endograft
      * or endograft with need for iliac conduit
      * or endovascular aneurysm repair with simultaneous femoral artery reconstruction or bypass
    * Subclavian/vertebral bypasses and transpositions
* Patients undergoing the above procedures will be included in the study regardless of their preoperative Hb level, and regardless of preoperative or intraoperative transfusion they might have received.

Exclusion Criteria:

* Veteran unable to consent
* Veteran unwilling to follow protocol (such as Jehovah's witnesses)
* Veteran with known history of hereditary anemias such as Thalassemia or Sickle cell disease
* Veteran with known history of hereditary bleeding disorders, such as factor VIII or factor IX deficiency
* Veteran with prior history of adverse reaction to blood administration, such as fever, rash, or hemolysis
* Veteran does not speak or understand English
* Veteran hemodynamically unstable or in cardiogenic shock for \>48 hours after the index procedure
* Veteran participating in another interventional trial whose objective is to evaluate the effect of transfusion on outcomes
* Pregnancy in female Veterans
* Veteran is a prisoner or in custody of law enforcement
* Prior randomization in the CSP#599
* Patients who are known to have tested positive for COVID-19 and have not recovered prior to consent will not be consented. Any participant who is known to have a positive COVID-19 test during the screening process and has not recovered will be excluded prior to randomization.
B: 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.
C: Inclusion Criteria:

* Patients are aged 16-70 undergoing either an autologous or allogeneic HSCT for any hematologic malignancy

Exclusion Criteria:

* Pregnant or lactating at the time of enrollment
* Already received red cell transfusion after HSCT but prior to enrollment
* Unable/unwilling to provide informed consent.
* Patients receiving HSCT for non-malignancy
D: Inclusion Criteria:

* Infants with a birth weight of 400 - 999g

Exclusion Criteria:

* Missing written parental consent.
* Gestational age \> 29 + 6/7 weeks
* Major congenital anomalies (including chromosomal aberrations, cyanotic congenital heart defects, syndromes likely affecting long-term outcome, and major congenital malformations requiring surgical correction during newborn period).
* Infants who died before 48 hours, infants in whom the clinical decision to withhold intensive care was made, infants who were not considered viable
* Participation in another study with ongoing use of an unlicensed investigational product from 28 days before study enrollment until the end of the study

Answer: B