Clinical trial · Interventional
Transfusion Strategy in Hematological Intensive Care Unit
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Transfusion Related Complication | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Single red blood packed cells Transfusion | Drug | — | UNRESOLVED |
| Two packed red blood cells Transfusion | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- ARM A
- description
- Two packed red blood cells will be transfused in patient with anemia defined as a hemoglobin level below 8 g / dL. Clinical and biological monitoring will be carried out later each day. If the hemoglobin is \<8 g / dL, two new packed red blood cells are transfused and so on.
- interventionNames
- Drug: Two packed red blood cells Transfusion
- type
- EXPERIMENTAL
- label
- ARM B
- description
- Single red blood packed cells Transfusion will be administered in patient with anemia defined as a hemoglobin level below 8 g/dL. Clinical and biological monitoring will be carried out later each day. If the hemoglobin is \<8 g / dL, a single unit is transfused and so on.
- interventionNames
- Drug: Single red blood packed cells Transfusion
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (13)
- RESULTShander A, Hofmann A, Ozawa S, Theusinger OM, Gombotz H, Spahn DR. Activity-based costs of blood transfusions in surgical patients at four hospitals. Transfusion. 2010 Apr;50(4):753-65. doi: 10.1111/j.1537-2995.2009.02518.x. Epub 2009 Dec 9. PMID 20003061
- RESULTMadjdpour C, Spahn DR. Allogeneic red blood cell transfusions: efficacy, risks, alternatives and indications. Br J Anaesth. 2005 Jul;95(1):33-42. doi: 10.1093/bja/aeh290. Epub 2004 Oct 14. PMID 15486006
- RESULTWang JK, Klein HG. Red blood cell transfusion in the treatment and management of anaemia: the search for the elusive transfusion trigger. Vox Sang. 2010 Jan;98(1):2-11. doi: 10.1111/j.1423-0410.2009.01223.x. Epub 2009 Aug 4. PMID 19682346
- RESULTMa M, Eckert K, Ralley F, Chin-Yee I. A retrospective study evaluating single-unit red blood cell transfusions in reducing allogeneic blood exposure. Transfus Med. 2005 Aug;15(4):307-12. doi: 10.1111/j.0958-7578.2005.00592.x. PMID 16101808
- RESULTLeal-Noval SR, Munoz-Gomez M, Jimenez-Sanchez M, Cayuela A, Leal-Romero M, Puppo-Moreno A, Enamorado J, Arellano-Orden V. Red blood cell transfusion in non-bleeding critically ill patients with moderate anemia: is there a benefit? Intensive Care Med. 2013 Mar;39(3):445-53. doi: 10.1007/s00134-012-2757-z. Epub 2012 Nov 27. PMID 23184038
- RESULTWatkins TC, Clark CT. Critically ill and septic patient: is red blood cell transfusion adding to the Domino Effect? J Infus Nurs. 2013 Mar-Apr;36(2):116-21. doi: 10.1097/NAN.0b013e318282a6cd. PMID 23455973
- RESULTRobitaille 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.