Transfusion Related Complication
Conditions
Brief summary
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.
Interventions
DRUGSingle red blood packed cells Transfusion
DRUGTwo packed red blood cells Transfusion
Sponsors
University Hospital, Caen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Inpatients with either acute leukemia patient receiving intensive chemotherapy or autologous transplantation for lymphoma, allogeneic stem cell transplantation
Exclusion criteria
* ischemic heart failure * acute promyelocytic leukemia * ALKERAN autologous conditioning (myeloma patient) * disseminated intravascular coagulation * hemorrhagic syndrome * stroke * any vital distress at diagnosis * creatinine clearance \<50 ml/min * liver disease with ALT (alanine aminotransferase)/AST(aspartate aminotransferase) ≥2.5 ULN (upper limit of normal) (except if related to tumor) * pregnant female * autoimmune hemolytic anemia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of severe complications (grade 3 or more) | up to 1 month after the last day of hospitalization | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of bleeding | up to 1 month after the last day of hospitalization | number of patient with bleeding grade 3 or more |
| Transfusion related events | up to 1 month after the last day of hospitalization | Number of transfusion related events defined as any complication that the physician declared to be related to the transfusion (fever, infection, pulmonary edema..) |
| Time to erythroid recovery | up to 1 month after the last day of hospitalization | Time from randomization to last transfusion |
| Quality of life | up to 1 month after the last day of hospitalization | Functional Assessment of Cancer Therapy and QLC30 |
| number of RBP transfused | up to 1 month after the last day of hospitalization | — |
| Transfusion performance | up to 24 hours | difference between hemoglobin level before and 24 hours after transfusion |
| transfusion in out patient | up to 1 month after the last day of hospitalization | number of RBP transfused after leaving the unit |
| Failure to respect the randomisation arm | up to 1 month after the last day of hospitalization | number of patient in arm B that received 2 RBP instead of single RBP |
| time of aplasia | up to 1 month after the last day of hospitalization | from 1st day with neutrophils\<500 to first day with neutrophils\>500/mm3 |
Countries
France
Outcome results
None listed