The Effect of Blood Transfusion on Endothelial Function

Anemia Clinical Trial

Official title:

The Effect of Blood Transfusion on Endothelial Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02161042
• Other study ID #: 100344
• Status: Completed
• Phase: N/A
• First received: June 6, 2014
• Last updated: October 4, 2016
• Start date: August 2011
• Est. completion date: June 2016

Study information

• Verified date: October 2016
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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 Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia
• MDS

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No