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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.
Information provided by (Responsible Party):
Wellspect HealthCare Identifier:
First received: February 6, 2009
Last updated: September 27, 2012
Last verified: September 2012
The primary objective of the study is to compare the immunological status after either autologous blood transfusion as administered by Bellovac® ABT or allogenic blood transfusion, with regards to change in Natural Killer (NK) cell frequency in patients undergoing total knee replacement.

Condition Intervention
Arthroplasty, Replacement, Knee
Blood Transfusion, Autologous
Blood Transfusion
Device: Bellovac ABT
Procedure: Allogenic Blood Transfusion

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open , Prospective, Randomized, Parallel Group Study to Investigate Whether Postoperatively Collected and Transfused Autologous Whole Blood Improves the Immunological Status in Comparison to Allogenic Blood Transfusion in Patients Undergoing Total Knee Replacement

Resource links provided by NLM:

Further study details as provided by Wellspect HealthCare:

Primary Outcome Measures:
  • Frequency of Natural Killer Cells as Measured With Flow Cytometry. [ Time Frame: Baseline ]
  • Frequency of Natural Killer Cells as Measured With Flow Cytometry. [ Time Frame: Day 5 postop ]
  • Frequency of Natural Killer Cells as Measured With Flow Cytometry. [ Time Frame: Day 8 postop ]
  • Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry) [ Time Frame: Baseline ]
  • Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry) [ Time Frame: Day 5 postop ]
  • Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry) [ Time Frame: Day 8 postop ]

Secondary Outcome Measures:
  • Interferon Gamma [ Time Frame: Baseline ]
  • Interferon Gamma [ Time Frame: Day 5 postop ]
  • Interferon Gamma [ Time Frame: Day 8 postop ]
  • Interleukin-2 [ Time Frame: Baseline ]
  • Interleukin-2 [ Time Frame: Day 5 postop ]
  • Interleukin-2 [ Time Frame: Day 8 postop ]
  • Interleukin-4 [ Time Frame: Baseline ]
  • Interleukin-4 [ Time Frame: Day 5 postop ]
  • Interleukin-4 [ Time Frame: Day 8 postop ]
  • Interleukin-6 [ Time Frame: Baseline ]
  • Interleukin-6 [ Time Frame: Day 5 postop ]
  • Interleukin-6 [ Time Frame: Day 8 postop ]
  • Interleukin-10 [ Time Frame: Baseline ]
  • Interleukin-10 [ Time Frame: Day 5 postop ]
  • Interleukin-10 [ Time Frame: Day 8 postop ]
  • TNF-Alpha [ Time Frame: Baseline ]
  • TNF-Alpha [ Time Frame: Day 5 postop ]
  • TNF-Alpha [ Time Frame: Day 8 postop ]
  • Hemoglobin [ Time Frame: Baseline ]
  • Hemoglobin [ Time Frame: Day 1 postop ]
  • Hemoglobin [ Time Frame: Day 5 postop ]
  • Hemoglobin [ Time Frame: Day 8 postop ]
  • Erythrocyte Volume Fraction [ Time Frame: Baseline ]
  • Erythrocyte Volume Fraction [ Time Frame: Day 1 postop ]
  • Erythrocyte Volume Fraction [ Time Frame: Day 5 postop ]
  • Erythrocyte Volume Fraction [ Time Frame: Day 8 postop ]
  • Leucocyte Particle Concentration [ Time Frame: Baseline ]
  • Leucocyte Particle Concentration [ Time Frame: Day 1 postop ]
  • Leucocyte Particle Concentration [ Time Frame: Day 5 postop ]
  • Leucocyte Particle Concentration [ Time Frame: Day 8 postop ]
  • Lymphocytes [ Time Frame: Baseline ]
  • Lymphocytes [ Time Frame: Day 1 postop ]
  • Lymphocytes [ Time Frame: Day 5 postop ]
  • Lymphocytes [ Time Frame: Day 8 postop ]

Enrollment: 45
Study Start Date: January 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Autologous Blood Transfusion Device: Bellovac ABT
Bellovac ABT (autologous blood)
Active Comparator: Allogenic Blood Transfusion Procedure: Allogenic Blood Transfusion
Transfusion of allogenic ("bank") blood.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Provision of informed consent
  • Male and female patients aged 18 years and over scheduled for total knee replacement
  • Subjects classified as ASA Physical Status Classification System class P1, P2 or P3 according to the American Society of Anaesthesiology

Exclusion Criteria:

  • Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study site)
  • Pre-operatively haemoglobin below normal range as judged by the investigator
  • Previous enrolment or randomisation to treatment in the present study
  • Expected or confirmed participation in another clinical study during the study period
  • Severe non-compliance to protocol as judged by the investigator and/or Astra Tech
  • Current symptoms of haemophilia
  • History of or presence of malignant disease with propensity for systemic spread during the last 5 years
  • Current or expected use of cytotoxic drugs
  • Current untreated anaemia (e.g. sickle cell anaemia) as deemed by investigator
  • Use of pre-donation
  • Use of recombinant erythropoetin
  • Use of other autologous blood transfusion than that with Bellovac ABT, e.g. washed and centrifuged blood like CellSaver
  Contacts and Locations
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Please refer to this study by its identifier: NCT00839241

Specjalistyczny Szpital Im. Alfreda Sokolowskiego
Szczecin, Poland, 70 891
Sponsors and Collaborators
Wellspect HealthCare
Study Director: Magnus Jacobsson, MD, PhD, Prof. Dentsply Sirona Implants
  More Information

Responsible Party: Wellspect HealthCare 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 processed this record on May 25, 2017