The Impact of Red Cell Age on Product Utilization in the Chronically Transfused Outpatient Population

NCT02393508 | Unknown Phase 3

• 1 other identifier: 18-16748
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this study, the investigators will be evaluating the impact of red blood cell age in patients receiving chronic blood transfusions in the outpatient setting. This study will have a double-bind, randomized trial design, meaning that the investigators and participants will not be told the group assignment at study enrollment. Study participants will be randomly divided into two groups (50% of participants in each group) by a computer generated block randomization schema. The 'fresh blood' group will receive blood units that are 7 or less from the time of donor collection, and the 'aged blood' group will receive blood units that are greater than 21 to 42 days from the time of donor collection. The number of units of blood transfused will be decided based on the participant's hemoglobin level before blood transfusion. The primary goal of our study is to compare annual red blood cell product use (the number of units given per patient in a year). The investigators will also be comparing groups to evaluate the transfusion reaction frequency, iron burden (based on the level of ferritin in the blood), overall transfusion and care cost difference, and participant time spent in outpatient departments. Our hypothesis is that use of fresh blood in chronically transfused patients will lead to a decrease the in red cell transfusion rate, with subsequent clinical benefits including reduction of transfusion reaction frequency and systemic iron burden. This study will be taking place within the Calgary Zone of Alberta Health Services only.

Conditions

Bone Marrow Failure Syndrome

Keywords

transfusion, red blood cell; transfusion reaction; quality of life

Outcome Measures

Primary Outcomes (1)

• Red blood cell transfusion rate

  Product utilization, comparing the number and frequency of red blood cell units transfused to the chronically transfused outpatient population eligible for trial participation

  1 year from the time of enrollment

Secondary Outcomes (4)

• Ferritin burden

  At enrollment, 3 months, 6 months, 9 months and 12 months

• Total cost of blood product transfusion

  1 year from the time of enrollment

• Number of hours spent receiving blood products

  1 year from the time of enrollment

• Transfusion reaction frequency

  1 year from the time of enrollment

Study Arms (2)

Fresh Human Red Blood Cells

ACTIVE COMPARATOR

Participants will receive transfusion of human donor red blood cells that are less than or equal to 7 days of age from the time of donation.

Other: Fresh Human Red Blood Cells

Aged Human Red Blood Cells

ACTIVE COMPARATOR

Participants will receive transfusion of human donor red blood cells that are greater than 21 days and up to a maximum of 42 days of age from the time of donation.

Other: Aged Human Red Blood Cells

Interventions

Fresh Human Red Blood Cells OTHER

Red cell units for transfusion will be acquired from Canadian Blood Services (CBS), as a part of their usual stock to the Calgary Zone. Blood will be processed and prepared by CBS according to their standard protocol. The red cell units assigned to patients as a part of this trial will not be manipulated in any way prior to participant transfusion.

Fresh Human Red Blood Cells

Aged Human Red Blood Cells OTHER

Red cell units for transfusion will be acquired from Canadian Blood Services (CBS), as a part of their usual stock to the Calgary Zone. Blood will be processed and prepared by CBS according to their standard protocol. The red cell units assigned to patients as a part of this trial will not be manipulated in any way prior to participant transfusion.

Aged Human Red Blood Cells

Eligibility Criteria

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

You may qualify if:

• Patients requiring outpatient chronic red cell transfusions (2 or more red blood cell units per month for at least 3 consecutive months) in an ambulatory clinic within the Calgary Zone

You may not qualify if:

• prerequisite for fresh or irradiated blood due to a pre-existing medical reason
• hemodialysis dependence
• chronic disease that has acutely decompensated, with a life expectancy of less than 3 months

Sponsors & Collaborators

• University of Calgary: lead

Related Publications (8)

• Hebert PC, Chin-Yee I, Fergusson D, Blajchman M, Martineau R, Clinch J, Olberg B; Canadian Critical Care Trials Group. A pilot trial evaluating the clinical effects of prolonged storage of red cells. Anesth Analg. 2005 May;100(5):1433-1458. doi: 10.1213/01.ANE.0000148690.48803.27.

  PMID: 15845701 BACKGROUND

• Taylor RW, O'Brien J, Trottier SJ, Manganaro L, Cytron M, Lesko MF, Arnzen K, Cappadoro C, Fu M, Plisco MS, Sadaka FG, Veremakis C. Red blood cell transfusions and nosocomial infections in critically ill patients. Crit Care Med. 2006 Sep;34(9):2302-8; quiz 2309. doi: 10.1097/01.CCM.0000234034.51040.7F.

  PMID: 16849995 BACKGROUND

• Weinberg JA, McGwin G Jr, Griffin RL, Huynh VQ, Cherry SA 3rd, Marques MB, Reiff DA, Kerby JD, Rue LW 3rd. Age of transfused blood: an independent predictor of mortality despite universal leukoreduction. J Trauma. 2008 Aug;65(2):279-82; discussion 282-4. doi: 10.1097/TA.0b013e31817c9687.

  PMID: 18695462 BACKGROUND

• Spinella PC, Carroll CL, Staff I, Gross R, Mc Quay J, Keibel L, Wade CE, Holcomb JB. Duration of red blood cell storage is associated with increased incidence of deep vein thrombosis and in hospital mortality in patients with traumatic injuries. Crit Care. 2009;13(5):R151. doi: 10.1186/cc8050. Epub 2009 Sep 22.

  PMID: 19772604 BACKGROUND

• Koch CG, Li L, Sessler DI, Figueroa P, Hoeltge GA, Mihaljevic T, Blackstone EH. Duration of red-cell storage and complications after cardiac surgery. N Engl J Med. 2008 Mar 20;358(12):1229-39. doi: 10.1056/NEJMoa070403.

  PMID: 18354101 BACKGROUND

• Mynster T, Nielsen HJ. The impact of storage time of transfused blood on postoperative infectious complications in rectal cancer surgery. Danish RANX05 Colorectal Cancer Study Group. Scand J Gastroenterol. 2000 Feb;35(2):212-7. doi: 10.1080/003655200750024416.

  PMID: 10720122 BACKGROUND

• Yuruk K, Milstein DM, Bezemer R, Bartels SA, Biemond BJ, Ince C. Transfusion of banked red blood cells and the effects on hemorrheology and microvascular hemodynamics in anemic hematology outpatients. Transfusion. 2013 Jun;53(6):1346-52. doi: 10.1111/j.1537-2995.2012.03905.x. Epub 2012 Sep 24.

  PMID: 22998160 BACKGROUND

• Triulzi DJ, Yazer MH. Clinical studies of the effect of blood storage on patient outcomes. Transfus Apher Sci. 2010 Aug;43(1):95-106. doi: 10.1016/j.transci.2010.05.013. Epub 2010 Jul 24.

  PMID: 20656558 BACKGROUND

MeSH Terms

Conditions

Bone Marrow Failure Disorders; Transfusion Reaction

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Immune System Diseases

Study Officials

• Meer-Taher Shabani-Rad, MD, FRCPC

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Transfusion Medicine Fellow (Co-Investigator)

Study Record Dates

• First Submitted: March 5, 2015
• First Posted: March 19, 2015
• Study Start: September 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 22, 2015

Record last verified: 2015-12