Trial Outcomes & Findings for 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") (NCT NCT00839241)

NCT ID: NCT00839241

Last Updated: 2021-11-11

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 45 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2021-11-11

Participant Flow

Participant milestones

Measure	Autologous Blood Transfusion	Allogenic Blood Transfusion
Overall Study STARTED	20	25
Overall Study COMPLETED	15	8
Overall Study NOT COMPLETED	5	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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")

Baseline characteristics by cohort

Measure	Autologous Blood Transfusion n=20 Participants	Allogenic Blood Transfusion n=25 Participants	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	12 Participants n=7 Participants	19 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Age, Continuous	67.1 years STANDARD_DEVIATION 10.3 • n=5 Participants	66.6 years STANDARD_DEVIATION 8.3 • n=7 Participants	66.8 years STANDARD_DEVIATION 9.1 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	20 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment Poland	20 participants n=5 Participants	25 participants n=7 Participants	45 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Measure	Autologous Blood Transfusion n=20 Participants	Allogenic Blood Transfusion n=25 Participants
Frequency of Natural Killer Cells as Measured With Flow Cytometry.	2.98 total number of cells * 10^5/mL Standard Deviation 1.62	2.26 total number of cells * 10^5/mL Standard Deviation 1.13

PRIMARY outcome

Timeframe: Day 5 postop

Outcome measures

Measure	Autologous Blood Transfusion n=20 Participants	Allogenic Blood Transfusion n=25 Participants
Frequency of Natural Killer Cells as Measured With Flow Cytometry.	2.79 total number of cells * 10^5/mL Standard Deviation 2.11	1.96 total number of cells * 10^5/mL Standard Deviation 1.19

PRIMARY outcome

Timeframe: Day 8 postop

Outcome measures

Measure	Autologous Blood Transfusion n=20 Participants	Allogenic Blood Transfusion n=25 Participants
Frequency of Natural Killer Cells as Measured With Flow Cytometry.	2.80 total number of cells * 10^5/mL Standard Deviation 2.03	1.79 total number of cells * 10^5/mL Standard Deviation 0.94

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Measure	Autologous Blood Transfusion n=20 Participants	Allogenic Blood Transfusion n=25 Participants
Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry)	13.8 Percent Standard Deviation 6.3	12.3 Percent Standard Deviation 4.6

PRIMARY outcome

Timeframe: Day 5 postop

Outcome measures

Measure	Autologous Blood Transfusion n=20 Participants	Allogenic Blood Transfusion n=25 Participants
Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry)	12.1 Percent Standard Deviation 5.3	9.3 Percent Standard Deviation 4.3

PRIMARY outcome

Timeframe: Day 8 postop

Outcome measures

Measure	Autologous Blood Transfusion n=20 Participants	Allogenic Blood Transfusion n=25 Participants
Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry)	11.5 Percent Standard Deviation 5.6	7.4 Percent Standard Deviation 2.5

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Measure	Autologous Blood Transfusion n=20 Participants	Allogenic Blood Transfusion n=25 Participants
Interferon Gamma	5.6 pg/mL Standard Deviation 2.6	6.2 pg/mL Standard Deviation 4.2

SECONDARY outcome

Timeframe: Day 5 postop

Outcome measures

Measure	Autologous Blood Transfusion n=20 Participants	Allogenic Blood Transfusion n=25 Participants
Interferon Gamma	6.5 pg/mL Standard Deviation 2.1	5.5 pg/mL Standard Deviation 3.8

SECONDARY outcome

Timeframe: Day 8 postop

Outcome measures

Measure	Autologous Blood Transfusion n=20 Participants	Allogenic Blood Transfusion n=25 Participants
Interferon Gamma	6.25 pg/mL Standard Deviation 2.5	6.99 pg/mL Standard Deviation 4.8

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Measure	Autologous Blood Transfusion n=20 Participants	Allogenic Blood Transfusion n=25 Participants
Interleukin-2	6.3 pg/mL Standard Deviation 3.3	8.4 pg/mL Standard Deviation 6.9

SECONDARY outcome

Timeframe: Day 5 postop

Outcome measures

Measure	Autologous Blood Transfusion n=20 Participants	Allogenic Blood Transfusion n=25 Participants
Interleukin-2	6.4 pg/mL Standard Deviation 3.6	8.0 pg/mL Standard Deviation 6.7

SECONDARY outcome

Timeframe: Day 8 postop

Outcome measures

Measure	Autologous Blood Transfusion n=20 Participants	Allogenic Blood Transfusion n=25 Participants
Interleukin-2	7.1 pg/mL Standard Deviation 5.5	8.8 pg/mL Standard Deviation 7.1

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Measure	Autologous Blood Transfusion n=20 Participants	Allogenic Blood Transfusion n=25 Participants
Interleukin-4	4.9 pg/mL Standard Deviation 2.2	6.1 pg/mL Standard Deviation 4.7

SECONDARY outcome

Timeframe: Day 5 postop

Outcome measures

Measure	Autologous Blood Transfusion n=20 Participants	Allogenic Blood Transfusion n=25 Participants
Interleukin-4	5.5 pg/mL Standard Deviation 2.2	5.4 pg/mL Standard Deviation 4.4

SECONDARY outcome

Timeframe: Day 8 postop

Outcome measures

Measure	Autologous Blood Transfusion n=20 Participants	Allogenic Blood Transfusion n=25 Participants
Interleukin-4	5.5 pg/mL Standard Deviation 3.5	6.2 pg/mL Standard Deviation 4.4

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Measure	Autologous Blood Transfusion n=20 Participants	Allogenic Blood Transfusion n=25 Participants
Interleukin-6	6.1 pg/mL Standard Deviation 2.9	7.0 pg/mL Standard Deviation 4.9

SECONDARY outcome

Timeframe: Day 5 postop

Outcome measures

Measure	Autologous Blood Transfusion n=20 Participants	Allogenic Blood Transfusion n=25 Participants
Interleukin-6	10.5 pg/mL Standard Deviation 2.8	14.0 pg/mL Standard Deviation 7.8

SECONDARY outcome

Timeframe: Day 8 postop

Outcome measures

Measure	Autologous Blood Transfusion n=20 Participants	Allogenic Blood Transfusion n=25 Participants
Interleukin-6	9.1 pg/mL Standard Deviation 4.2	12.5 pg/mL Standard Deviation 3.6

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Measure	Autologous Blood Transfusion n=20 Participants	Allogenic Blood Transfusion n=25 Participants
Interleukin-10	5.8 pg/mL Standard Deviation 3.9	8.0 pg/mL Standard Deviation 6.2

SECONDARY outcome

Timeframe: Day 5 postop

Outcome measures

Measure	Autologous Blood Transfusion n=20 Participants	Allogenic Blood Transfusion n=25 Participants
Interleukin-10	7.5 pg/mL Standard Deviation 3.4	7.9 pg/mL Standard Deviation 5.7

SECONDARY outcome

Timeframe: Day 8 postop

Outcome measures

Measure	Autologous Blood Transfusion n=20 Participants	Allogenic Blood Transfusion n=25 Participants
Interleukin-10	6.5 pg/mL Standard Deviation 4.1	8.9 pg/mL Standard Deviation 6.2

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Measure	Autologous Blood Transfusion n=20 Participants	Allogenic Blood Transfusion n=25 Participants
TNF-Alpha	6.7 pg/mL Standard Deviation 2.9	8.0 pg/mL Standard Deviation 6.3

SECONDARY outcome

Timeframe: Day 5 postop

Outcome measures

Measure	Autologous Blood Transfusion n=20 Participants	Allogenic Blood Transfusion n=25 Participants
TNF-Alpha	7.1 pg/mL Standard Deviation 3.4	7.4 pg/mL Standard Deviation 5.4

SECONDARY outcome

Timeframe: Day 8 postop

Outcome measures

Measure	Autologous Blood Transfusion n=20 Participants	Allogenic Blood Transfusion n=25 Participants
TNF-Alpha	7.6 pg/mL Standard Deviation 3.4	8.0 pg/mL Standard Deviation 5.7

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Measure	Autologous Blood Transfusion n=20 Participants	Allogenic Blood Transfusion n=25 Participants
Hemoglobin	14.5 g/dL Standard Deviation 1.0	13.3 g/dL Standard Deviation 1.3

SECONDARY outcome

Timeframe: Day 1 postop

Outcome measures

Measure	Autologous Blood Transfusion n=20 Participants	Allogenic Blood Transfusion n=25 Participants
Hemoglobin	11.7 g/dL Standard Deviation 0.9	11.0 g/dL Standard Deviation 1.5

SECONDARY outcome

Timeframe: Day 5 postop

Outcome measures

Measure	Autologous Blood Transfusion n=20 Participants	Allogenic Blood Transfusion n=25 Participants
Hemoglobin	11.1 g/dL Standard Deviation 1.5	10.5 g/dL Standard Deviation 1.5

SECONDARY outcome

Timeframe: Day 8 postop

Outcome measures

Measure	Autologous Blood Transfusion n=20 Participants	Allogenic Blood Transfusion n=25 Participants
Hemoglobin	11.1 g/dL Standard Deviation 1.4	10.6 g/dL Standard Deviation 1.0

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Measure	Autologous Blood Transfusion n=20 Participants	Allogenic Blood Transfusion n=25 Participants
Erythrocyte Volume Fraction	45.1 percentage of blood volume Standard Deviation 2.4	41.3 percentage of blood volume Standard Deviation 3.3

SECONDARY outcome

Timeframe: Day 1 postop

Outcome measures

Measure	Autologous Blood Transfusion n=20 Participants	Allogenic Blood Transfusion n=25 Participants
Erythrocyte Volume Fraction	36.1 percentage of blood volume Standard Deviation 2.7	33.8 percentage of blood volume Standard Deviation 4.3

SECONDARY outcome

Timeframe: Day 5 postop

Outcome measures

Measure	Autologous Blood Transfusion n=20 Participants	Allogenic Blood Transfusion n=25 Participants
Erythrocyte Volume Fraction	34.7 percentage of blood volume Standard Deviation 4.6	32.8 percentage of blood volume Standard Deviation 4.9

SECONDARY outcome

Timeframe: Day 8 postop

Outcome measures

Measure	Autologous Blood Transfusion n=20 Participants	Allogenic Blood Transfusion n=25 Participants
Erythrocyte Volume Fraction	35.1 percentage of blood volume Standard Deviation 3.8	33.3 percentage of blood volume Standard Deviation 3.4

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Measure	Autologous Blood Transfusion n=20 Participants	Allogenic Blood Transfusion n=25 Participants
Leucocyte Particle Concentration	5.8 10^3/uL Standard Deviation 1.3	5.3 10^3/uL Standard Deviation 1.6

SECONDARY outcome

Timeframe: Day 1 postop

Outcome measures

Measure	Autologous Blood Transfusion n=20 Participants	Allogenic Blood Transfusion n=25 Participants
Leucocyte Particle Concentration	9.4 10^3/uL Standard Deviation 3.0	7.3 10^3/uL Standard Deviation 2.3

SECONDARY outcome

Timeframe: Day 5 postop

Outcome measures

Measure	Autologous Blood Transfusion n=20 Participants	Allogenic Blood Transfusion n=25 Participants
Leucocyte Particle Concentration	6.7 10^3/uL Standard Deviation 1.8	6.1 10^3/uL Standard Deviation 2.2

SECONDARY outcome

Timeframe: Day 8 postop

Outcome measures

Measure	Autologous Blood Transfusion n=20 Participants	Allogenic Blood Transfusion n=25 Participants
Leucocyte Particle Concentration	7.2 10^3/uL Standard Deviation 1.7	5.7 10^3/uL Standard Deviation 1.5

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Measure	Autologous Blood Transfusion n=20 Participants	Allogenic Blood Transfusion n=25 Participants
Lymphocytes	38.3 percentage of white blood cells Standard Deviation 13	47.3 percentage of white blood cells Standard Deviation 14

SECONDARY outcome

Timeframe: Day 1 postop

Outcome measures

Measure	Autologous Blood Transfusion n=20 Participants	Allogenic Blood Transfusion n=25 Participants
Lymphocytes	22.7 percentage of white blood cells Standard Deviation 11	24.3 percentage of white blood cells Standard Deviation 11

SECONDARY outcome

Timeframe: Day 5 postop

Outcome measures

Measure	Autologous Blood Transfusion n=20 Participants	Allogenic Blood Transfusion n=25 Participants
Lymphocytes	33.3 percentage of white blood cells Standard Deviation 12	36.1 percentage of white blood cells Standard Deviation 11

SECONDARY outcome

Timeframe: Day 8 postop

Outcome measures

Measure	Autologous Blood Transfusion n=20 Participants	Allogenic Blood Transfusion n=25 Participants
Lymphocytes	33.6 percentage of white blood cells Standard Deviation 7	42.5 percentage of white blood cells Standard Deviation 11

Adverse Events

Autologous Blood Transfusion

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Allogenic Blood Transfusion

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Autologous Blood Transfusion n=20 participants at risk	Allogenic Blood Transfusion n=25 participants at risk
Musculoskeletal and connective tissue disorders Haemoarthrosis of the operated knee	0.00% 0/20	100.0% 1/1 • Number of events 1
Vascular disorders Crural phlebothrombosis of the operated limb	0.00% 0/20	100.0% 1/1 • Number of events 1

Other adverse events

Measure	Autologous Blood Transfusion n=20 participants at risk	Allogenic Blood Transfusion n=25 participants at risk
General disorders Fever	20.0% 4/20 • Number of events 4	20.0% 5/25 • Number of events 5
Vascular disorders Hypotension	0.00% 0/20	8.0% 2/25 • Number of events 2
Vascular disorders Hypertension	10.0% 2/20 • Number of events 2	4.0% 1/25 • Number of events 1
Metabolism and nutrition disorders Constipation	20.0% 4/20 • Number of events 4	0.00% 0/25

Additional Information

Head of Clinical Research Area Health Care

Astra Tech AB

Phone: +46317761000

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60