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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

Tracking Information
First Submitted Date June 6, 2014
First Posted Date June 11, 2014
Last Update Posted Date October 5, 2016
Study Start Date August 2011
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 9, 2014)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Effect of Blood Transfusion on Endothelial Function
Official Title The Effect of Blood Transfusion on Endothelial Function
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.

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.
Study Type Observational
Study Design Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients who come to IV therapy or Oncology day Unit requiring a blood transfusion
Condition
  • MDS
  • Anemia
Intervention Not Provided
Study Groups/Cohorts
  • fresh blood Transfusion
  • Old blood transfusion
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: June 9, 2014)
40
Original Estimated Enrollment Same as current
Actual Study Completion Date June 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT02161042
Other Study ID Numbers 100344
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Shahar Lavi, Lawson Health Research Institute
Study Sponsor Lawson Health Research Institute
Collaborators Not Provided
Investigators Not Provided
PRS Account Lawson Health Research Institute
Verification Date October 2016