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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)

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00839241
Enrollment
45
Registered
2009-02-09
Start date
2009-01-31
Completion date
2009-06-30
Last updated
2021-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DEVICEBellovac ABT

Bellovac ABT (autologous blood)

PROCEDUREAllogenic Blood Transfusion

Transfusion of allogenic (bank) blood.

Sponsors

Wellspect HealthCare
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Frequency of Natural Killer Cells as Measured With Flow Cytometry.Baseline
Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry)Baseline

Secondary

MeasureTime frame
Interleukin-4Baseline
Interleukin-6Baseline
Interleukin-10Baseline
TNF-AlphaBaseline
Interferon GammaBaseline
Erythrocyte Volume FractionBaseline
Leucocyte Particle ConcentrationBaseline
LymphocytesBaseline
HemoglobinBaseline
Interleukin-2Baseline

Countries

Poland

Participant flow

Participants by arm

ArmCount
Autologous Blood Transfusion20
Allogenic Blood Transfusion25
Total45

Baseline characteristics

CharacteristicAllogenic Blood TransfusionAutologous Blood TransfusionTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
13 Participants13 Participants26 Participants
Age, Categorical
Between 18 and 65 years
12 Participants7 Participants19 Participants
Age, Continuous66.6 years
STANDARD_DEVIATION 8.3
67.1 years
STANDARD_DEVIATION 10.3
66.8 years
STANDARD_DEVIATION 9.1
Region of Enrollment
Poland
25 participants20 participants45 participants
Sex: Female, Male
Female
20 Participants13 Participants33 Participants
Sex: Female, Male
Male
5 Participants7 Participants12 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
10 / 208 / 25
serious
Total, serious adverse events
0 / 202 / 25

Outcome results

Primary

Frequency of Natural Killer Cells as Measured With Flow Cytometry.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Autologous Blood TransfusionFrequency of Natural Killer Cells as Measured With Flow Cytometry.2.98 total number of cells * 10^5/mLStandard Deviation 1.62
Allogenic Blood TransfusionFrequency of Natural Killer Cells as Measured With Flow Cytometry.2.26 total number of cells * 10^5/mLStandard Deviation 1.13
Primary

Frequency of Natural Killer Cells as Measured With Flow Cytometry.

Time frame: Day 5 postop

ArmMeasureValue (MEAN)Dispersion
Autologous Blood TransfusionFrequency of Natural Killer Cells as Measured With Flow Cytometry.2.79 total number of cells * 10^5/mLStandard Deviation 2.11
Allogenic Blood TransfusionFrequency of Natural Killer Cells as Measured With Flow Cytometry.1.96 total number of cells * 10^5/mLStandard Deviation 1.19
Primary

Frequency of Natural Killer Cells as Measured With Flow Cytometry.

Time frame: Day 8 postop

ArmMeasureValue (MEAN)Dispersion
Autologous Blood TransfusionFrequency of Natural Killer Cells as Measured With Flow Cytometry.2.80 total number of cells * 10^5/mLStandard Deviation 2.03
Allogenic Blood TransfusionFrequency of Natural Killer Cells as Measured With Flow Cytometry.1.79 total number of cells * 10^5/mLStandard Deviation 0.94
Primary

Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry)

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Autologous Blood TransfusionNatural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry)13.8 PercentStandard Deviation 6.3
Allogenic Blood TransfusionNatural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry)12.3 PercentStandard Deviation 4.6
Primary

Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry)

Time frame: Day 5 postop

ArmMeasureValue (MEAN)Dispersion
Autologous Blood TransfusionNatural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry)12.1 PercentStandard Deviation 5.3
Allogenic Blood TransfusionNatural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry)9.3 PercentStandard Deviation 4.3
Primary

Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry)

Time frame: Day 8 postop

ArmMeasureValue (MEAN)Dispersion
Autologous Blood TransfusionNatural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry)11.5 PercentStandard Deviation 5.6
Allogenic Blood TransfusionNatural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry)7.4 PercentStandard Deviation 2.5
Secondary

Erythrocyte Volume Fraction

Time frame: Day 8 postop

ArmMeasureValue (MEAN)Dispersion
Autologous Blood TransfusionErythrocyte Volume Fraction35.1 percentage of blood volumeStandard Deviation 3.8
Allogenic Blood TransfusionErythrocyte Volume Fraction33.3 percentage of blood volumeStandard Deviation 3.4
Secondary

Erythrocyte Volume Fraction

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Autologous Blood TransfusionErythrocyte Volume Fraction45.1 percentage of blood volumeStandard Deviation 2.4
Allogenic Blood TransfusionErythrocyte Volume Fraction41.3 percentage of blood volumeStandard Deviation 3.3
Secondary

Erythrocyte Volume Fraction

Time frame: Day 1 postop

ArmMeasureValue (MEAN)Dispersion
Autologous Blood TransfusionErythrocyte Volume Fraction36.1 percentage of blood volumeStandard Deviation 2.7
Allogenic Blood TransfusionErythrocyte Volume Fraction33.8 percentage of blood volumeStandard Deviation 4.3
Secondary

Erythrocyte Volume Fraction

Time frame: Day 5 postop

ArmMeasureValue (MEAN)Dispersion
Autologous Blood TransfusionErythrocyte Volume Fraction34.7 percentage of blood volumeStandard Deviation 4.6
Allogenic Blood TransfusionErythrocyte Volume Fraction32.8 percentage of blood volumeStandard Deviation 4.9
Secondary

Hemoglobin

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Autologous Blood TransfusionHemoglobin14.5 g/dLStandard Deviation 1
Allogenic Blood TransfusionHemoglobin13.3 g/dLStandard Deviation 1.3
Secondary

Hemoglobin

Time frame: Day 8 postop

ArmMeasureValue (MEAN)Dispersion
Autologous Blood TransfusionHemoglobin11.1 g/dLStandard Deviation 1.4
Allogenic Blood TransfusionHemoglobin10.6 g/dLStandard Deviation 1
Secondary

Hemoglobin

Time frame: Day 5 postop

ArmMeasureValue (MEAN)Dispersion
Autologous Blood TransfusionHemoglobin11.1 g/dLStandard Deviation 1.5
Allogenic Blood TransfusionHemoglobin10.5 g/dLStandard Deviation 1.5
Secondary

Hemoglobin

Time frame: Day 1 postop

ArmMeasureValue (MEAN)Dispersion
Autologous Blood TransfusionHemoglobin11.7 g/dLStandard Deviation 0.9
Allogenic Blood TransfusionHemoglobin11.0 g/dLStandard Deviation 1.5
Secondary

Interferon Gamma

Time frame: Day 8 postop

ArmMeasureValue (MEAN)Dispersion
Autologous Blood TransfusionInterferon Gamma6.25 pg/mLStandard Deviation 2.5
Allogenic Blood TransfusionInterferon Gamma6.99 pg/mLStandard Deviation 4.8
Secondary

Interferon Gamma

Time frame: Day 5 postop

ArmMeasureValue (MEAN)Dispersion
Autologous Blood TransfusionInterferon Gamma6.5 pg/mLStandard Deviation 2.1
Allogenic Blood TransfusionInterferon Gamma5.5 pg/mLStandard Deviation 3.8
Secondary

Interferon Gamma

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Autologous Blood TransfusionInterferon Gamma5.6 pg/mLStandard Deviation 2.6
Allogenic Blood TransfusionInterferon Gamma6.2 pg/mLStandard Deviation 4.2
Secondary

Interleukin-10

Time frame: Day 8 postop

ArmMeasureValue (MEAN)Dispersion
Autologous Blood TransfusionInterleukin-106.5 pg/mLStandard Deviation 4.1
Allogenic Blood TransfusionInterleukin-108.9 pg/mLStandard Deviation 6.2
Secondary

Interleukin-10

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Autologous Blood TransfusionInterleukin-105.8 pg/mLStandard Deviation 3.9
Allogenic Blood TransfusionInterleukin-108.0 pg/mLStandard Deviation 6.2
Secondary

Interleukin-10

Time frame: Day 5 postop

ArmMeasureValue (MEAN)Dispersion
Autologous Blood TransfusionInterleukin-107.5 pg/mLStandard Deviation 3.4
Allogenic Blood TransfusionInterleukin-107.9 pg/mLStandard Deviation 5.7
Secondary

Interleukin-2

Time frame: Day 8 postop

ArmMeasureValue (MEAN)Dispersion
Autologous Blood TransfusionInterleukin-27.1 pg/mLStandard Deviation 5.5
Allogenic Blood TransfusionInterleukin-28.8 pg/mLStandard Deviation 7.1
Secondary

Interleukin-2

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Autologous Blood TransfusionInterleukin-26.3 pg/mLStandard Deviation 3.3
Allogenic Blood TransfusionInterleukin-28.4 pg/mLStandard Deviation 6.9
Secondary

Interleukin-2

Time frame: Day 5 postop

ArmMeasureValue (MEAN)Dispersion
Autologous Blood TransfusionInterleukin-26.4 pg/mLStandard Deviation 3.6
Allogenic Blood TransfusionInterleukin-28.0 pg/mLStandard Deviation 6.7
Secondary

Interleukin-4

Time frame: Day 8 postop

ArmMeasureValue (MEAN)Dispersion
Autologous Blood TransfusionInterleukin-45.5 pg/mLStandard Deviation 3.5
Allogenic Blood TransfusionInterleukin-46.2 pg/mLStandard Deviation 4.4
Secondary

Interleukin-4

Time frame: Day 5 postop

ArmMeasureValue (MEAN)Dispersion
Autologous Blood TransfusionInterleukin-45.5 pg/mLStandard Deviation 2.2
Allogenic Blood TransfusionInterleukin-45.4 pg/mLStandard Deviation 4.4
Secondary

Interleukin-4

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Autologous Blood TransfusionInterleukin-44.9 pg/mLStandard Deviation 2.2
Allogenic Blood TransfusionInterleukin-46.1 pg/mLStandard Deviation 4.7
Secondary

Interleukin-6

Time frame: Day 8 postop

ArmMeasureValue (MEAN)Dispersion
Autologous Blood TransfusionInterleukin-69.1 pg/mLStandard Deviation 4.2
Allogenic Blood TransfusionInterleukin-612.5 pg/mLStandard Deviation 3.6
Secondary

Interleukin-6

Time frame: Day 5 postop

ArmMeasureValue (MEAN)Dispersion
Autologous Blood TransfusionInterleukin-610.5 pg/mLStandard Deviation 2.8
Allogenic Blood TransfusionInterleukin-614.0 pg/mLStandard Deviation 7.8
Secondary

Interleukin-6

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Autologous Blood TransfusionInterleukin-66.1 pg/mLStandard Deviation 2.9
Allogenic Blood TransfusionInterleukin-67.0 pg/mLStandard Deviation 4.9
Secondary

Leucocyte Particle Concentration

Time frame: Day 1 postop

ArmMeasureValue (MEAN)Dispersion
Autologous Blood TransfusionLeucocyte Particle Concentration9.4 10^3/uLStandard Deviation 3
Allogenic Blood TransfusionLeucocyte Particle Concentration7.3 10^3/uLStandard Deviation 2.3
Secondary

Leucocyte Particle Concentration

Time frame: Day 8 postop

ArmMeasureValue (MEAN)Dispersion
Autologous Blood TransfusionLeucocyte Particle Concentration7.2 10^3/uLStandard Deviation 1.7
Allogenic Blood TransfusionLeucocyte Particle Concentration5.7 10^3/uLStandard Deviation 1.5
Secondary

Leucocyte Particle Concentration

Time frame: Day 5 postop

ArmMeasureValue (MEAN)Dispersion
Autologous Blood TransfusionLeucocyte Particle Concentration6.7 10^3/uLStandard Deviation 1.8
Allogenic Blood TransfusionLeucocyte Particle Concentration6.1 10^3/uLStandard Deviation 2.2
Secondary

Leucocyte Particle Concentration

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Autologous Blood TransfusionLeucocyte Particle Concentration5.8 10^3/uLStandard Deviation 1.3
Allogenic Blood TransfusionLeucocyte Particle Concentration5.3 10^3/uLStandard Deviation 1.6
Secondary

Lymphocytes

Time frame: Day 8 postop

ArmMeasureValue (MEAN)Dispersion
Autologous Blood TransfusionLymphocytes33.6 percentage of white blood cellsStandard Deviation 7
Allogenic Blood TransfusionLymphocytes42.5 percentage of white blood cellsStandard Deviation 11
Secondary

Lymphocytes

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Autologous Blood TransfusionLymphocytes38.3 percentage of white blood cellsStandard Deviation 13
Allogenic Blood TransfusionLymphocytes47.3 percentage of white blood cellsStandard Deviation 14
Secondary

Lymphocytes

Time frame: Day 1 postop

ArmMeasureValue (MEAN)Dispersion
Autologous Blood TransfusionLymphocytes22.7 percentage of white blood cellsStandard Deviation 11
Allogenic Blood TransfusionLymphocytes24.3 percentage of white blood cellsStandard Deviation 11
Secondary

Lymphocytes

Time frame: Day 5 postop

ArmMeasureValue (MEAN)Dispersion
Autologous Blood TransfusionLymphocytes33.3 percentage of white blood cellsStandard Deviation 12
Allogenic Blood TransfusionLymphocytes36.1 percentage of white blood cellsStandard Deviation 11
Secondary

TNF-Alpha

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Autologous Blood TransfusionTNF-Alpha6.7 pg/mLStandard Deviation 2.9
Allogenic Blood TransfusionTNF-Alpha8.0 pg/mLStandard Deviation 6.3
Secondary

TNF-Alpha

Time frame: Day 5 postop

ArmMeasureValue (MEAN)Dispersion
Autologous Blood TransfusionTNF-Alpha7.1 pg/mLStandard Deviation 3.4
Allogenic Blood TransfusionTNF-Alpha7.4 pg/mLStandard Deviation 5.4
Secondary

TNF-Alpha

Time frame: Day 8 postop

ArmMeasureValue (MEAN)Dispersion
Autologous Blood TransfusionTNF-Alpha7.6 pg/mLStandard Deviation 3.4
Allogenic Blood TransfusionTNF-Alpha8.0 pg/mLStandard Deviation 5.7

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026