Transfusion Strategy in Hematological Intensive Care Unit

NCT02461264 | Unknown Phase 3

• 1 other identifier: 14-128
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

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.

Conditions

Transfusion Related Complication

Outcome Measures

Primary Outcomes (1)

• Number 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.

  up to 1 month after the last day of hospitalization

Secondary Outcomes (9)

• number of RBP transfused

  up to 1 month after the last day of hospitalization

• Incidence of bleeding

  up to 1 month after the last day of hospitalization

• Transfusion related events

  up to 1 month after the last day of hospitalization

• Time to erythroid recovery

  up to 1 month after the last day of hospitalization

• Quality of life

  up to 1 month after the last day of hospitalization

Study Arms (2)

ARM A

ACTIVE COMPARATOR

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.

Drug: Two packed red blood cells Transfusion

ARM B

EXPERIMENTAL

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.

Drug: Single red blood packed cells Transfusion

Interventions

Single red blood packed cells Transfusion DRUG

ARM B

Two packed red blood cells Transfusion DRUG

ARM A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Inpatients with either acute leukemia patient receiving intensive chemotherapy or autologous transplantation for lymphoma, allogeneic stem cell transplantation

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

University Hospital

Caen, 14000, France

RECRUITING

Related Publications (13)

• Shander 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 RESULT

• Madjdpour 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 RESULT

• Wang 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 RESULT

• Ma 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 RESULT

• Leal-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 RESULT

• Watkins 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 RESULT

• 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.

  PMID: 23220014 RESULT

• 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.

  PMID: 21933858 RESULT

• Carson JL, Carless PA, Hebert PC. Transfusion thresholds and other strategies for guiding allogeneic red blood cell transfusion. Cochrane Database Syst Rev. 2012 Apr 18;4(4):CD002042. doi: 10.1002/14651858.CD002042.pub3.

  PMID: 22513904 RESULT

• Salpeter SR, Buckley JS, Chatterjee S. Impact of more restrictive blood transfusion strategies on clinical outcomes: a meta-analysis and systematic review. Am J Med. 2014 Feb;127(2):124-131.e3. doi: 10.1016/j.amjmed.2013.09.017. Epub 2013 Oct 7.

  PMID: 24331453 RESULT

• 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.

  RESULT

• Chantepie SP, Mear JB, Briant AR, Vilque JP, Gac AC, Cheze S, Girault S, Turlure P, Marolleau JP, Lebon D, Charbonnier A, Jardin F, Lenain P, Peyro-Saint-Paul L, Abonnet V, Dutheil JJ, Chene Y, Bazin A, Reman O, Parienti JJ. Effect of single-unit transfusion in patients treated for haematological disease including acute leukemia: A multicenter randomized controlled clinical trial. Leuk Res. 2023 Jun;129:107058. doi: 10.1016/j.leukres.2023.107058. Epub 2023 Mar 18.

  PMID: 37080000 DERIVED

• 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.

  PMID: 26592377 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 3, 2015
• Study Start: January 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: September 1, 2019
• Last Updated: April 22, 2019

Record last verified: 2019-04

Locations

FR (1)