Patients with acute hematological disease (acute leukemia, aplastic anemia, hematopoietic stem cells autologous or allogeneic ...) and hospitalized in an intensive care unit hematology require compensation of anemia and thrombocytopenia by blood transfusions of red blood packed cells (RBP) or platelet concentrates (PC).The AFSSAPS (Agence Française de Sécurité Sanitaire des Produits de Santé) recommendations (2002) specify the need to transfuse 2 RBP in case of symptomatic anemia usually for a hemoglobin between 6 and 10 g / dL. These recommendations allow to transfuse a single RBP for very elderly patients or in cases of associated heart disease (heart failure). A recent development (2012) on post-transfusion pulmonary edema overload recommends transfusion unit by unit for high risk patients. More recently, a Swiss team has historically compared transfusion policies in 2 139 patients with hematological malignancies. The first group received 2 RBP transfusion in case of symptomatic anemia or hemoglobin level \<6 g / dL. The other group only received 1 RBP at each transfusion. In total 2212 units in 1548 transfusions were performed and the 1 RBP transfusion policy has resulted in a 25% decrease in the number of RBP used without any complication. In a prospective single-center pilot study, we showed that transfusing a single RBP was possible without increasing the side effects of anemia, without complications and allow an overall reduction in consumption of red blood cell units. Several meta-analyzes reported in intensive care or bleeding situations that a restrictive use of transfusions significantly reduces cardiac events, bleeding, bacterial infections and mortality. The number of patient to be treated to prevent one death is 33. The main objective is to demonstrate in a randomized trial that the restrictive strategy (transfusion of a single unit at each transfusion) is not inferior to the liberal strategy (transfusion of 2 unit at each transfusion) in terms of severe complication. Transfusion are performed in case of hemoglobin level \<8g/dL. Key secondary objectives are to reduce the number of RBP used and the cost of hospitalization with a comparison of complications/mortality in the 2 groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
230
University Hospital
Caen, France
RECRUITINGNumber of severe complications (grade 3 or more)
complications are defined as: stroke, transient ischemic attack, acute coronary syndrome, heart failure, arrhythmias or conduction cardiac disease, deep vein thrombosis, pulmonary embolism, elevated troponin, transfer to intensive care unit, death from any cause, new or progressive radiographic infiltrates, infections related to transfusion.
Time frame: up to 1 month after the last day of hospitalization
number of RBP transfused
Time frame: up to 1 month after the last day of hospitalization
Incidence of bleeding
number of patient with bleeding grade 3 or more
Time frame: up to 1 month after the last day of hospitalization
Transfusion related events
Number of transfusion related events defined as any complication that the physician declared to be related to the transfusion (fever, infection, pulmonary edema..)
Time frame: up to 1 month after the last day of hospitalization
Time to erythroid recovery
Time from randomization to last transfusion
Time frame: up to 1 month after the last day of hospitalization
Quality of life
Functional Assessment of Cancer Therapy and QLC30
Time frame: up to 1 month after the last day of hospitalization
time of aplasia
from 1st day with neutrophils\<500 to first day with neutrophils\>500/mm3
Time frame: up to 1 month after the last day of hospitalization
Transfusion performance
difference between hemoglobin level before and 24 hours after transfusion
Time frame: up to 24 hours
transfusion in out patient
number of RBP transfused after leaving the unit
Time frame: up to 1 month after the last day of hospitalization
Failure to respect the randomisation arm
number of patient in arm B that received 2 RBP instead of single RBP
Time frame: up to 1 month after the last day of hospitalization
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