Clinical trial NCT02461264: Transfusion Strategy in Hematological Intensive Care Unit
Official title: Randomized Multicenter Trial of Two Transfusion Strategies for Patient Receiving Chemotherapy for Acute Leukemia or Hematopoietic Stem Cells With Medico-economic Evaluation of Cost Minimization.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Transfusion Related Complication
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2015-06-03
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of severe complications (grade 3 or more)
timeFrame: up to 1 month after the last day of hospitalization
Secondary outcomes:
measure: number of RBP transfused
timeFrame: up to 1 month after the last day of hospitalization
measure: Incidence of bleeding
timeFrame: up to 1 month after the last day of hospitalization
measure: Transfusion related events
timeFrame: up to 1 month after the last day of hospitalization
measure: Time to erythroid recovery
timeFrame: up to 1 month after the last day of hospitalization
measure: Quality of life
timeFrame: up to 1 month after the last day of hospitalization
measure: time of aplasia
timeFrame: up to 1 month after the last day of hospitalization
measure: Transfusion performance
timeFrame: up to 24 hours
measure: transfusion in out patient
timeFrame: up to 1 month after the last day of hospitalization
measure: Failure to respect the randomisation arm
timeFrame: up to 1 month after the last day of hospitalization
Other outcomes:
Locations:
city: Caen
country: France
facility: University Hospital
Study officials:
References:
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citation: Robitaille N, Lacroix J, Alexandrov L, Clayton L, Cortier M, Schultz KR, Bittencourt H, Duval M. Excess of veno-occlusive disease in a randomized clinical trial on a higher trigger for red blood cell transfusion after bone marrow transplantation: a canadian blood and marrow transplant group trial. Biol Blood Marrow Transplant. 2013 Mar;19(3):468-73. doi: 10.1016/j.bbmt.2012.12.002. Epub 2012 Dec 7.
citation: Berger MD, Gerber B, Arn K, Senn O, Schanz U, Stussi G. Significant reduction of red blood cell transfusion requirements by changing from a double-unit to a single-unit transfusion policy in patients receiving intensive chemotherapy or stem cell transplantation. Haematologica. 2012 Jan;97(1):116-22. doi: 10.3324/haematol.2011.047035. Epub 2011 Sep 20.
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citation: Mear JB, Chantepie SP, Gac AC, Bazin A and Reman O. A restrictive transfusion Strategy allow a reduction of the number of packed red blood cells: result of a pilot study; Abstract 2217; PH-AB153 Bone marrow Transplant 2014.
citation: Chantepie SP, Mear JB, Guittet L, Dervaux B, Marolleau JP, Jardin F, Dutheil JJ, Parienti JJ, Vilque JP, Reman O. Transfusion strategy in hematological intensive care unit: study protocol for a randomized controlled trial. Trials. 2015 Nov 23;16:533. doi: 10.1186/s13063-015-1057-7.