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")

Not Applicable

Completed

Conditions: Blood Transfusion, Autologous
Blood Transfusion
Arthroplasty, Replacement, Knee

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Allogenic Blood Transfusion	Allogenic Blood Transfusion	-
Autologous Blood Transfusion	Bellovac ABT	-

Primary Outcome Measures

Name	Time	Method
Frequency of Natural Killer Cells as Measured With Flow Cytometry.	Day 8 postop
Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry)	Day 8 postop

Secondary Outcome Measures

Name	Time	Method
Interleukin-2	Day 8 postop
Interleukin-6	Day 8 postop
Erythrocyte Volume Fraction	Day 8 postop
Leucocyte Particle Concentration	Day 8 postop
Interleukin-4	Day 8 postop
Interleukin-10	Day 8 postop
TNF-Alpha	Day 8 postop
Hemoglobin	Day 8 postop
Interferon Gamma	Day 8 postop
Lymphocytes	Day 8 postop