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)

Study Overview
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Brief Summary
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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.

Official Title
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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

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

Intervention / Treatment
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* Device: Bellovac ABT
* Procedure: Allogenic Blood Transfusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous Blood Transfusion<br> | Device: Bellovac ABT<br>* Bellovac ABT (autologous blood)<br>|
| Active Comparator: Allogenic Blood Transfusion<br> | Procedure: Allogenic Blood Transfusion<br>* Transfusion of allogenic (bank) blood.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Natural Killer Cells as Measured With Flow Cytometry. |  | Baseline | 
| Frequency of Natural Killer Cells as Measured With Flow Cytometry. |  | Day 5 postop | 
| Frequency of Natural Killer Cells as Measured With Flow Cytometry. |  | Day 8 postop | 
| Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry) |  | Baseline | 
| Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry) |  | Day 5 postop | 
| Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry) |  | Day 8 postop | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interferon Gamma |  | Baseline | 
| Interferon Gamma |  | Day 5 postop | 
| Interferon Gamma |  | Day 8 postop | 
| Interleukin-2 |  | Baseline | 
| Interleukin-2 |  | Day 5 postop | 
| Interleukin-2 |  | Day 8 postop | 
| Interleukin-4 |  | Baseline | 
| Interleukin-4 |  | Day 5 postop | 
| Interleukin-4 |  | Day 8 postop | 
| Interleukin-6 |  | Baseline | 
| Interleukin-6 |  | Day 5 postop | 
| Interleukin-6 |  | Day 8 postop | 
| Interleukin-10 |  | Baseline | 
| Interleukin-10 |  | Day 5 postop | 
| Interleukin-10 |  | Day 8 postop | 
| TNF-Alpha |  | Baseline | 
| TNF-Alpha |  | Day 5 postop | 
| TNF-Alpha |  | Day 8 postop | 
| Hemoglobin |  | Baseline | 
| Hemoglobin |  | Day 1 postop | 
| Hemoglobin |  | Day 5 postop | 
| Hemoglobin |  | Day 8 postop | 
| Erythrocyte Volume Fraction |  | Baseline | 
| Erythrocyte Volume Fraction |  | Day 1 postop | 
| Erythrocyte Volume Fraction |  | Day 5 postop | 
| Erythrocyte Volume Fraction |  | Day 8 postop | 
| Leucocyte Particle Concentration |  | Baseline | 
| Leucocyte Particle Concentration |  | Day 1 postop | 
| Leucocyte Particle Concentration |  | Day 5 postop | 
| Leucocyte Particle Concentration |  | Day 8 postop | 
| Lymphocytes |  | Baseline | 
| Lymphocytes |  | Day 1 postop | 
| Lymphocytes |  | Day 5 postop | 
| Lymphocytes |  | Day 8 postop |