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CompletedNCT02161042Updated Oct 5, 2016

The Effect of Blood Transfusion on Endothelial Function

An observational study in MDS and Anemia, sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's. Completed at 1 site in Canada. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2016-10-05.

Sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
40
Ages
18 Years to 95 Years
Sex
All
01

Study summary

Blood transfusion is often used to treat patients with Anemia. The period of storage of blood products prior to use for transfusion may vary. Prolonged storage of blood products may result in changing their biochemistry.

This study aims to look into whether the transfusion of "old" blood, which is stored for more than 7 days, as compared to the transfusion of "Fresh" blood, which is stored for less than 7 days, will affect endothelial function.

Read the detailed description

Endothelial function assessed pre and post transfusion. The EndoPAT uses a unique bio-sensors that are placed on the fingertips to measure pressure. The test takes about 20-25 minutes. During the procedure the participant will have biosensors placed on the index finger of each hand. The nondominant arm will have a blood pressure cuff applied with sufficient pressure for five minutes. At the end of the test the device will provide a reading that assesses the level of endothelial function/dysfunction.

02

Conditions studied

  • MDS
  • Anemia

Keywords

  • Blood transfusion
  • Storage Lesion
  • Endothelial dysfunction
  • Nitric Oxide
03

In context

Lead sponsor

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's is the lead sponsor of 352 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who come to IV therapy or Oncology day Unit requiring a blood transfusion

Inclusion criteria

  • Age is > 18 years
  • Need recurrent blood transfusion

Exclusion criteria

Exclusion Criteria:

  • Latex Allergy
  • Life expectancy is less than 6 months
  • History or evidence of drug or alcohol abuse in the last 12 months
  • Any medical condition that will place the participant at a higher risk if they participate in the study
05

Study design

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No

Groups and cohorts

  • fresh blood Transfusion
  • Old blood transfusion
06

What researchers measure

Primary outcomes

  1. Endothelial function

    The function of the blood vessels will be assessed with the EndoPAT device. This test is done 15 minutes prior to the transfusion and again 30 minutes post the transfusion. Patients that will receive both fresh and old blood will be included.

    Time frame: Change in endothelial function compared to baseline. Test is done 15 minutes prior to transfusion and 30 minutes post blood transfusion. The test is repeated when patient received another blood transfusion. The results of the change are compared.

07

Study locations

1 site
  • London Health Sciences Centre
    London, Ontario N6A5A5, Canada
08

References and documents

Publications

  • Donadee C, Raat NJ, Kanias T, Tejero J, Lee JS, Kelley EE, Zhao X, Liu C, Reynolds H, Azarov I, Frizzell S, Meyer EM, Donnenberg AD, Qu L, Triulzi D, Kim-Shapiro DB, Gladwin MT. Nitric oxide scavenging by red blood cell microparticles and cell-free hemoglobin as a mechanism for the red cell storage lesion. Circulation. 2011 Jul 26;124(4):465-76. doi: 10.1161/CIRCULATIONAHA.110.008698. Epub 2011 Jul 11. PubMed 21747051 ↗
  • Kim-Shapiro DB, Lee J, Gladwin MT. Storage lesion: role of red blood cell breakdown. Transfusion. 2011 Apr;51(4):844-51. doi: 10.1111/j.1537-2995.2011.03100.x. PubMed 21496045 ↗
  • Chin-Yee I, Arya N, d'Almeida MS. The red cell storage lesion and its implication for transfusion. Transfus Sci. 1997 Sep;18(3):447-58. doi: 10.1016/S0955-3886(97)00043-X. PubMed 10175158 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 5, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02161042
Lead sponsor
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
Responsible party
Shahar Lavi (Interventional Cardiologist, London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's) — Principal investigator
First posted
Jun 11, 2014
Start date
Aug 2011
Primary completion
Jan 2016
Completion
Jun 2016
Last update
Oct 5, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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