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Stored RBC Transfusion and Immonomodulation

Sponsor
Università degli Studi di Ferrara (Other)
Overall Status
Completed
CT.gov ID
NCT01976234
Collaborator
(none)
181
Enrollment
1
Location
2
Arms
27
Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Fresh RBC
  • Other: Old RBC
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
181 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Screening
Official Title:
Infective Complication After Surgery and Transfusion of Allogenic RBC Fresh or Stored
Study Start Date :
Sep 1, 2013
Actual Primary Completion Date :
Dec 1, 2015
Actual Study Completion Date :
Dec 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Fresh group

Fresh group will receive RBC stored for less than 14 days

Other: Fresh RBC
Patients will receive fresh blood only
Active Comparator: Old group

Old group will receive RBC stored for 14 days or more

Other: Old RBC
Other Names:
  • Patients will receive blood stored for 14 days or more

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of infections [28 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sant'Anna Hospital Ferrara Italy 44121

    Sponsors and Collaborators

    • Università degli Studi di Ferrara

    Investigators

    • Principal Investigator: Savino Spadaro, Università degli Studi di Ferrara

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Savino Spadaro, Researcher, Università degli Studi di Ferrara
    ClinicalTrials.gov Identifier:
    NCT01976234
    Other Study ID Numbers:
    • 04121985
    First Posted:
    Nov 5, 2013
    Last Update Posted:
    Feb 3, 2016
    Last Verified:
    Feb 1, 2016

    Study Results

    No Results Posted as of Feb 3, 2016