Stored RBC Transfusion and Immonomodulation

Infections Clinical Trial

Official title:

Infective Complication After Surgery and Transfusion of Allogenic RBC Fresh or Stored

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01976234
• Other study ID #: 04121985
• Status: Completed
• Phase: N/A
• First received: September 30, 2013
• Last updated: February 2, 2016
• Start date: September 2013
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Università degli Studi di Ferrara
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Screening

Related Conditions & MeSH terms

• Infections

Intervention

Other:
• Fresh RBC
Patients will receive fresh blood only
• Old RBC

Locations

Country	Name	City	State
Italy	Sant'Anna Hospital	Ferrara

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Ferrara

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Juffermans NP, Vlaar AP, Prins DJ, Goslings JC, Binnekade JM. The age of red blood cells is associated with bacterial infections in critically ill trauma patients. Blood Transfus. 2012 Jul;10(3):290-5. doi: 10.2450/2012.0068-11. Epub 2012 Feb 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of infections		28 days	Yes