Stored RBC Transfusion and Immonomodulation
February 2, 2016 updated by: Savino Spadaro, Università degli Studi di Ferrara
Infective Complication After Surgery and Transfusion of Allogenic RBC Fresh or Stored
Transfusion of RBC is associated with post operative infections.
Our hypothesis is that stored blood could be related with increased post operative infection risk.
Surgical patients transfused during the operation or immediately after will be included in our study.
Patients will receive fresh or old blood during the whole recovery.
Study Overview
Study Type
Interventional
Enrollment (Actual)
181
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Ferrara, Italy, 44121
- Sant'Anna Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients transfused during or in 24h after surgical operation
Exclusion Criteria:
- Patients transfused during the 30 days before the operation
- Immunodepressed patients
- Infections during the 30 days before operations
- Emergency surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Fresh group
Fresh group will receive RBC stored for less than 14 days
|
Patients will receive fresh blood only
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Active Comparator: Old group
Old group will receive RBC stored for 14 days or more
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Incidence of infections
Time Frame: 28 days
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Savino Spadaro, Università degli Studi di Ferrara
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
September 30, 2013
First Submitted That Met QC Criteria
October 29, 2013
First Posted (Estimate)
November 5, 2013
Study Record Updates
Last Update Posted (Estimate)
February 3, 2016
Last Update Submitted That Met QC Criteria
February 2, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 04121985
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.