- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02161042
The Effect of Blood Transfusion on Endothelial Function
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.
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Ontario
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London, Ontario, Canada, N6A5A5
- London Health Sciences Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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fresh blood Transfusion
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Old blood transfusion
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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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.
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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.
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Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 100344
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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