Transfusion Strategy in Hematological Intensive Care Unit

Transfusion Related Complication Clinical Trial

— 1VERSUS2CGR  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02461264
• Other study ID #: 14-128
• Status: Recruiting
• Phase: Phase 3
• Start date: January 2016
• Est. completion date: September 2019

Study information

• Verified date: April 2019
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: September 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Transfusion Related Complication

Intervention

Drug:
• Single red blood packed cells Transfusion

• Two packed red blood cells Transfusion

Locations

Country	Name	City	State
France	University Hospital	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

References & Publications (11)

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 transplan — View Citation

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):CD002042. doi: 10.1002/14651858.CD002042.pub3. Review. Update in: Cochrane Databas — View Citation

Leal-Noval SR, Muñoz-Gómez M, Jiménez-Sánchez 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 — View Citation

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. — View Citation

Madjdpour C, Spahn DR. Allogeneic red blood cell transfusions: efficacy, risks, alternatives and indications. Br J Anaesth. 2005 Jul;95(1):33-42. Epub 2004 Oct 14. Review. — View 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.

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 canadi — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	number of RBP transfused		up to 1 month after the last day of hospitalization
Secondary	Incidence of bleeding	number of patient with bleeding grade 3 or more	up to 1 month after the last day of hospitalization
Secondary	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..)	up to 1 month after the last day of hospitalization
Secondary	Time to erythroid recovery	Time from randomization to last transfusion	up to 1 month after the last day of hospitalization
Secondary	Quality of life	Functional Assessment of Cancer Therapy and QLC30	up to 1 month after the last day of hospitalization
Secondary	time of aplasia	from 1st day with neutrophils<500 to first day with neutrophils>500/mm3	up to 1 month after the last day of hospitalization
Secondary	Transfusion performance	difference between hemoglobin level before and 24 hours after transfusion	up to 24 hours
Secondary	transfusion in out patient	number of RBP transfused after leaving the unit	up to 1 month after the last day of hospitalization
Secondary	Failure to respect the randomisation arm	number of patient in arm B that received 2 RBP instead of single RBP	up to 1 month after the last day of hospitalization