The Effect of Blood Transfusion on Endothelial Function
1 other identifier
observational
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 6, 2014
CompletedFirst Posted
Study publicly available on registry
June 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedOctober 5, 2016
October 1, 2016
4.4 years
June 6, 2014
October 4, 2016
Conditions
Keywords
Outcome Measures
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.
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.
Study Arms (2)
fresh blood Transfusion
Old blood transfusion
Eligibility Criteria
Patients who come to IV therapy or Oncology day Unit requiring a blood transfusion
You may qualify if:
- Age is \> 18 years
- Need recurrent blood transfusion
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
London Health Sciences Centre
London, Ontario, N6A5A5, Canada
Related Publications (3)
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.
PMID: 21747051BACKGROUNDKim-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.
PMID: 21496045BACKGROUNDChin-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.
PMID: 10175158BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Interventional Cardiologist
Study Record Dates
First Submitted
June 6, 2014
First Posted
June 11, 2014
Study Start
August 1, 2011
Primary Completion
January 1, 2016
Study Completion
June 1, 2016
Last Updated
October 5, 2016
Record last verified: 2016-10