Please select the eligibility criteria that correspond to the clinical trial below.
Title: Red Blood Cell Transfusion Thresholds and QOL in MDS (EnhanceRBC): a Pilot, Feasibility Study
Brief Summary: Myelodysplastic syndromes (MDS) are bone marrow malignancies characterized by poor bone marrow function that may progress to acute myeloid leukemia. Many patients become red blood cell transfusion-dependent. Transfusion dependence is associated with inferior quality of life (QOL). However, the relationship between the degree of anemia and QOL is less clear. A commonly used transfusion strategy is to target the hemoglobin (Hb) in the range of 80-90 g/L (normal hemoglobin \> 120-130g/L). The question is: would a higher hemoglobin target lead to improvement in QOL despite the negative impact transfusion dependence may have on QOL (due to associated time commitments, expense, transfusion reactions etc). Several groups have prospectively shown that targeting hemoglobin levels of greater than 120 g/L (with hematopoietic growth factors (HGFs) and/or blood transfusions) or incremental increases of 15-20 g/L (with HGFs alone) were associated with improved QOL. The investigators MDS program has been conducting prospective assessments of QOL since 2007 in all registered and consented patients using a variety of validated questionnaires. Preliminary analysis (in 236 patients) revealed that, compared with an age-matched healthy general population, MDS patients have inferior QOL. Transfusion dependence and anemia were independently predictive of poor functioning, fatigue and decreased health utility. Furthermore, a hemoglobin level of ≥100 g/L seemed to be the key threshold for improvement in function and symptom scores. The investigators hypothesize that the target hemoglobins in transfusion dependent MDS patients are too low and this may account for their inferior quality of life. Our goal is to compare the effect on QOL of a restrictive strategy (which is the current standard of care), with a liberal transfusion strategy in a large randomized controlled trial of transfusion dependent MDS outpatients. Before embarking on such an endeavor, the investigators must first prove feasibility in a smaller pilot randomized controlled trial.


Options:
A: Inclusion Criteria:

* Adults patients with cancer admitted to ICU due to severe clinical condition AND
* Septic shock diagnosis AND
* Solid neoplasm AND
* Written informed consent

Exclusion Criteria:

* Age less than 18 years OR
* Leukemia or myelodysplastic syndrome OR
* Hematologic neoplasm OR
* Palliative treatment OR
* Renal Chronic Failure in Renal Replacement Therapy OR
* Karnofsky Status \< 50 OR
* Previous thrombocytopenia (platelet number lower than 50.000/mm3) OR
* Previous known coagulopathy OR
* Life-threatening bleeding OR
* Documented wish against transfusion OR
* Patients who refused participation in the study
B: 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
C: Inclusion Criteria:

* All patients with MDS ≥18 years of age
* Transfusion dependent: at least 1 transfusion per month in the last 8 weeks
* Hb \<100g/L pre transfusion
* Life expectancy \> 6 months

Exclusion Criteria:

* Unstable cardiac disease (Canadian Cardiovascular Society (CCS) III/IV angina or New York Heart Association (NYHA) III/IV congestive heart failure) requiring the transfusion target range to remain \>85-100 g/L at all times
* ECOG ≥3
* Patients with red cell antibodies against high frequency antigens or multiple antibodies (would potentially delay finding blood)
* Patients on ESA's or disease modifying agents (like azacitidine) for their MDS
D: Inclusion Criteria:

1. Age ≥18 years old at time of presentation
2. First ever episode aneurysmal SAH
3. Confirmed aneurysmal SAH diagnosis: as confirmed by treating Neurosurgeon or Neuro-interventionalist and supported by blood in subarachnoid space (demonstrated on cranial imaging or cerebrospinal fluid positive for xanthochromia) that is the result of a ruptured saccular aneurysm (confirmed by cranial imaging - cranial topography or magnetic resonance imaging angiography or catheter angiogram)
4. Incident hemoglobin ≤100g/L within 14 days following SAH (defined by first day of hospital presentation)

Exclusion Criteria:

1. Physician and or family decision to withdraw/withhold critical care at time of enrolment
2. Active bleeding with hemodynamic instability at time of enrolment
3. Patients with contra-indication or known objection to blood transfusions
4. SAH due to causes other than saccular aneurysm rupture including mycotic, traumatic and dissecting aneurysms, and aneurysms associated with arteriovenous malformations.

Answer: C