Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Feasibility Randomized Trial Comparing Restrictive and Liberal Blood Transfusion Strategies in Patients Requiring Four or More Days in Intensive Care
Brief Summary: The most effective transfusion practice in critically ill ICU patients is unknown. Currently the data is unclear as to whether a liberal or restrictive transfusion policy is of most benefit to patients in the short and longer term. The aim of this study is to test the hypothesis that liberal use of RBCs (Hb transfusion trigger ≤90g/L; target Hb range 91-110 g/L) to correct anaemia improves clinical outcomes compared with a restrictive transfusion trigger (Hb transfusion trigger ≤70 g/L; target Hb range 71-90 g/L) in anaemic critically ill patients requiring prolonged ICU stay (≥4 days).

Patients will be randomised to one of two transfusion strategies on a 1:1 basis

Group 1 "Restrictive RBC Transfusion group":

Patients will receive single unit RBC transfusions with a transfusion trigger of ≤70 g/L with a target Hb concentration of 71-90 g/L during the intervention period.

Group 2 "Liberal RBC transfusion group":

Patients will receive single unit RBC transfusions with a transfusion trigger of ≤90 g/L with a target of 91-110 g/L during intervention. These patients will all receive a transfusion on the day of randomisation.

Duration of Intervention:

Remainder of ICU stay or 14 days from randomisation, whichever is longer

Follow-Up

Quality of Life, mobility and health service usage questionnaires at 60 and 180 days.

This is a feasibility study that will provide essential data to ensure the success of the full trial. A qualitative study will also be carried out to explore potential reasons for non-recruitment and clinician concerns with the existing protocol. An exploratory biomarker sub-study will test whether a pro-inflammatory signal occurs in the liberally transfused group associated with transfusions.


Options:
A: Inclusion Criteria:

* Birth weight less than or equal to 1000 grams.
* Gestational age at least 22 weeks but less than 29 weeks
* Admitted to the NICU within 48 hours of life

Exclusion Criteria:

* Considered nonviable by the attending neonatologist
* Cyanotic congenital heart disease
* Parents opposed to the transfusion of blood
* Parents with hemoglobinopathy or congenital anemia
* In-utero fetal transfusion
* Twin-to-twin transfusion syndrome
* Isoimmune hemolytic disease
* Lack of parental consent
* Severe acute hemorrhage, acute shock, sepsis with coagulopathy, or need for perioperative transfusion.
* Prior blood transfusion on clinical grounds beyond the first 6 hours of life
* Infant has received erythropoietin prior to randomization, or is intended to receive erythropoietin through the neonatal course
* Congenital condition, other than premature birth, that adversely affects life expectancy or neurodevelopment.
* High probability that the family is socially disorganized to the point of being unable to attend follow-up at 22-26 months.
B: Inclusion Criteria:

* Hemoglobin level \<10 g/dL during the first 72 hours of ICU

Exclusion Criteria:

* Acute bleeding
* Hemoglobin level less than 7 g/dL
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:

* Primary hip fracture
* capable of informed consent
* independently dwelling
* able to ambulate independent of human assistance
* no active heart condition defined as no AMI within 3 months, no unstable angina or present incompensation/pulmonary oedema
* no regular transfusion demand or terminal disease.

Exclusion Criteria:

* Multiple fractures
* postop. immobilization due to to surgical reasons
* patient refusal to participate in relevant rehabilitation
* reoperation within 4. postoperative day.

Answer: C