NCT02161042

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

June 6, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 11, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

October 5, 2016

Status Verified

October 1, 2016

Enrollment Period

4.4 years

First QC Date

June 6, 2014

Last Update Submit

October 4, 2016

Conditions

Keywords

Blood transfusionStorage LesionEndothelial dysfunctionNitric Oxide

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

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

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: 21747051BACKGROUND
  • 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.

    PMID: 21496045BACKGROUND
  • 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.

    PMID: 10175158BACKGROUND

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

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

Locations