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The Effect of Blood Transfusion on Endothelial Function

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ClinicalTrials.gov Identifier: NCT02161042
Recruitment Status : Completed
First Posted : June 11, 2014
Last Update Posted : October 5, 2016
Sponsor:
Information provided by (Responsible Party):
Shahar Lavi, Lawson Health Research Institute

Brief 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.


Condition or disease
MDS Anemia

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.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: The Effect of Blood Transfusion on Endothelial Function
Study Start Date : August 2011
Actual Primary Completion Date : January 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Group/Cohort
fresh blood Transfusion
Old blood transfusion



Primary Outcome Measures :
  1. Endothelial function [ 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. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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
Criteria

Inclusion Criteria:

  • Age is > 18 years
  • Need recurrent blood transfusion

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02161042


Locations
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Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A5A5
Sponsors and Collaborators
Lawson Health Research Institute
Publications:
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Responsible Party: Shahar Lavi, Interventional Cardiologist, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02161042    
Other Study ID Numbers: 100344
First Posted: June 11, 2014    Key Record Dates
Last Update Posted: October 5, 2016
Last Verified: October 2016
Keywords provided by Shahar Lavi, Lawson Health Research Institute:
Blood transfusion
Storage Lesion
Endothelial dysfunction
Nitric Oxide