N/A
N=45
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")
Arthroplasty, Replacement, Knee · Blood Transfusion, Autologous · Blood Transfusion
Bottom Line
View on ClinicalTrials.gov: NCT00839241 ↗Enrolled (actual)
45
Serious AEs
4.4%
Results posted
Oct 2010
Primary outcome: Primary: Frequency of Natural Killer Cells as Measured With Flow Cytometry. — 2.98; 2.26 total number of cells * 10^5/mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bellovac ABT (Device); Allogenic Blood Transfusion (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wellspect HealthCare
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Natural Killer Cells as Measured With Flow Cytometry. |
2.80; 1.79 | — |
| PRIMARY Frequency of Natural Killer Cells as Measured With Flow Cytometry. |
2.80; 1.79 | — |
| PRIMARY Frequency of Natural Killer Cells as Measured With Flow Cytometry. |
2.80; 1.79 | — |
| PRIMARY Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry) |
11.5; 7.4 | — |
| PRIMARY Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry) |
11.5; 7.4 | — |
| PRIMARY Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry) |
11.5; 7.4 | — |
| SECONDARY Interferon Gamma |
6.25; 6.99 | — |
| SECONDARY Interferon Gamma |
6.25; 6.99 | — |
| SECONDARY Interferon Gamma |
6.25; 6.99 | — |
| SECONDARY Interleukin-2 |
7.1; 8.8 | — |
| SECONDARY Interleukin-2 |
7.1; 8.8 | — |
| SECONDARY Interleukin-2 |
7.1; 8.8 | — |
| SECONDARY Interleukin-4 |
5.5; 6.2 | — |
| SECONDARY Interleukin-4 |
5.5; 6.2 | — |
| SECONDARY Interleukin-4 |
5.5; 6.2 | — |
| SECONDARY Interleukin-6 |
9.1; 12.5 | — |
| SECONDARY Interleukin-6 |
9.1; 12.5 | — |
| SECONDARY Interleukin-6 |
9.1; 12.5 | — |
| SECONDARY Interleukin-10 |
6.5; 8.9 | — |
| SECONDARY Interleukin-10 |
6.5; 8.9 | — |
| SECONDARY Interleukin-10 |
6.5; 8.9 | — |
| SECONDARY TNF-Alpha |
7.6; 8.0 | — |
| SECONDARY TNF-Alpha |
7.6; 8.0 | — |
| SECONDARY TNF-Alpha |
7.6; 8.0 | — |
| SECONDARY Hemoglobin |
11.1; 10.6 | — |
| SECONDARY Hemoglobin |
11.1; 10.6 | — |
| SECONDARY Hemoglobin |
11.1; 10.6 | — |
| SECONDARY Hemoglobin |
11.1; 10.6 | — |
| SECONDARY Erythrocyte Volume Fraction |
35.1; 33.3 | — |
| SECONDARY Erythrocyte Volume Fraction |
35.1; 33.3 | — |
| SECONDARY Erythrocyte Volume Fraction |
35.1; 33.3 | — |
| SECONDARY Erythrocyte Volume Fraction |
35.1; 33.3 | — |
| SECONDARY Leucocyte Particle Concentration |
7.2; 5.7 | — |
| SECONDARY Leucocyte Particle Concentration |
7.2; 5.7 | — |
| SECONDARY Leucocyte Particle Concentration |
7.2; 5.7 | — |
| SECONDARY Leucocyte Particle Concentration |
7.2; 5.7 | — |
| SECONDARY Lymphocytes |
33.6; 42.5 | — |
| SECONDARY Lymphocytes |
33.6; 42.5 | — |
| SECONDARY Lymphocytes |
33.6; 42.5 | — |
| SECONDARY Lymphocytes |
33.6; 42.5 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00839241). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.