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A Clinical Study to Investigate if Transfusion of Patients Own Shed Blood Improves the Immunological Status in Comparison to Transfusion of Donor Blood ("Bank Blood")

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wellspect HealthCare
ClinicalTrials.gov Identifier:
NCT00839241
First received: February 6, 2009
Last updated: September 27, 2012
Last verified: September 2012
History of Changes
Results First Received: July 19, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Arthroplasty, Replacement, Knee
Blood Transfusion, Autologous
Blood Transfusion
Interventions: Device: Bellovac ABT
Procedure: Allogenic Blood Transfusion

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Autologous Blood Transfusion No text entered.
Allogenic Blood Transfusion No text entered.

Participant Flow:   Overall Study
    Autologous Blood Transfusion     Allogenic Blood Transfusion  
STARTED     20     25  
COMPLETED     15     8  
NOT COMPLETED     5     17  



  Baseline Characteristics
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Reporting Groups
  Description
Autologous Blood Transfusion No text entered.
Allogenic Blood Transfusion No text entered.
Total Total of all reporting groups

Baseline Measures
    Autologous Blood Transfusion     Allogenic Blood Transfusion     Total  
Number of Participants  
[units: participants]
 		  20     25     45  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     7     12     19  
>=65 years     13     13     26  
Age  
[units: years]
Mean ± Standard Deviation 		  67.1  ± 10.3     66.6  ± 8.3     66.8  ± 9.1  
Gender  
[units: participants]
 		     
Female     13     20     33  
Male     7     5     12  
Region of Enrollment  
[units: participants]
 		     
Poland     20     25     45  



  Outcome Measures
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1.  Primary:   Frequency of Natural Killer Cells as Measured With Flow Cytometry.   [ Time Frame: Baseline ]
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2.  Primary:   Frequency of Natural Killer Cells as Measured With Flow Cytometry.   [ Time Frame: Day 5 postop ]
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3.  Primary:   Frequency of Natural Killer Cells as Measured With Flow Cytometry.   [ Time Frame: Day 8 postop ]
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4.  Primary:   Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry)   [ Time Frame: Baseline ]
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5.  Primary:   Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry)   [ Time Frame: Day 5 postop ]
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6.  Primary:   Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry)   [ Time Frame: Day 8 postop ]
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7.  Secondary:   Interferon Gamma   [ Time Frame: Baseline ]
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8.  Secondary:   Interferon Gamma   [ Time Frame: Day 5 postop ]
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9.  Secondary:   Interferon Gamma   [ Time Frame: Day 8 postop ]
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10.  Secondary:   Interleukin-2   [ Time Frame: Baseline ]
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11.  Secondary:   Interleukin-2   [ Time Frame: Day 5 postop ]
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12.  Secondary:   Interleukin-2   [ Time Frame: Day 8 postop ]
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Measure Type Secondary
Measure Title Interleukin-2
Measure Description No text entered.
Time Frame Day 8 postop  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Autologous Blood Transfusion No text entered.
Allogenic Blood Transfusion No text entered.

Measured Values
    Autologous Blood Transfusion     Allogenic Blood Transfusion  
Number of Participants Analyzed  
[units: participants]
 		  20     25  
Interleukin-2  
[units: pg/mL]
Mean ± Standard Deviation 		  7.1  ± 5.5     8.8  ± 7.1  

No statistical analysis provided for Interleukin-2



13.  Secondary:   Interleukin-4   [ Time Frame: Baseline ]
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14.  Secondary:   Interleukin-4   [ Time Frame: Day 5 postop ]
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15.  Secondary:   Interleukin-4   [ Time Frame: Day 8 postop ]
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16.  Secondary:   Interleukin-6   [ Time Frame: Baseline ]
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17.  Secondary:   Interleukin-6   [ Time Frame: Day 5 postop ]
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18.  Secondary:   Interleukin-6   [ Time Frame: Day 8 postop ]
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19.  Secondary:   Interleukin-10   [ Time Frame: Baseline ]
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20.  Secondary:   Interleukin-10   [ Time Frame: Day 5 postop ]
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21.  Secondary:   Interleukin-10   [ Time Frame: Day 8 postop ]
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22.  Secondary:   TNF-Alpha   [ Time Frame: Baseline ]
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23.  Secondary:   TNF-Alpha   [ Time Frame: Day 5 postop ]
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24.  Secondary:   TNF-Alpha   [ Time Frame: Day 8 postop ]
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25.  Secondary:   Hemoglobin   [ Time Frame: Baseline ]
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26.  Secondary:   Hemoglobin   [ Time Frame: Day 1 postop ]
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27.  Secondary:   Hemoglobin   [ Time Frame: Day 5 postop ]
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28.  Secondary:   Hemoglobin   [ Time Frame: Day 8 postop ]
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29.  Secondary:   Erythrocyte Volume Fraction   [ Time Frame: Baseline ]
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30.  Secondary:   Erythrocyte Volume Fraction   [ Time Frame: Day 1 postop ]
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31.  Secondary:   Erythrocyte Volume Fraction   [ Time Frame: Day 5 postop ]
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32.  Secondary:   Erythrocyte Volume Fraction   [ Time Frame: Day 8 postop ]
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33.  Secondary:   Leucocyte Particle Concentration   [ Time Frame: Baseline ]
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34.  Secondary:   Leucocyte Particle Concentration   [ Time Frame: Day 1 postop ]
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35.  Secondary:   Leucocyte Particle Concentration   [ Time Frame: Day 5 postop ]
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36.  Secondary:   Leucocyte Particle Concentration   [ Time Frame: Day 8 postop ]
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37.  Secondary:   Lymphocytes   [ Time Frame: Baseline ]
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38.  Secondary:   Lymphocytes   [ Time Frame: Day 1 postop ]
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39.  Secondary:   Lymphocytes   [ Time Frame: Day 5 postop ]
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40.  Secondary:   Lymphocytes   [ Time Frame: Day 8 postop ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Head of Clinical Research Area Health Care
Organization: Astra Tech AB
phone: +46317761000


No publications provided


Responsible Party: Wellspect HealthCare
ClinicalTrials.gov Identifier: NCT00839241     History of Changes
Other Study ID Numbers: YA-ABT-0004
Study First Received: February 6, 2009
Results First Received: July 19, 2010
Last Updated: September 27, 2012
Health Authority: Poland: Bioethics Committee