Arthroplasty, Replacement, KneeNCT00839241
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")
A study testing Bellovac ABT and Allogenic Blood Transfusion in people with Arthroplasty, Replacement, Knee and Blood Transfusion, Autologous, run by Wellspect HealthCare at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Knee, Blood Transfusion, Autologous, Blood Transfusion
- What is being tested?
- Bellovac ABT and Allogenic Blood Transfusion
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2009to Jun 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Specjalistyczny Szpital Im. Alfreda Sokolowskiego
Szczecin, 70 891
About this study
Official title: 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
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.
- Being tested
- Bellovac ABT, Allogenic Blood Transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bellovac ABTDevice
Bellovac ABT (autologous blood)
Allogenic Blood TransfusionProcedure or surgery
Transfusion of allogenic ("bank") blood.
| Study group | Role | What they receive |
|---|---|---|
| Autologous Blood Transfusion | Experimental | Not described Receives: Device: Bellovac ABT |
| Allogenic Blood Transfusion | Active comparator | Not described Receives: Procedure: Allogenic Blood Transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Natural Killer Cells as Measured With Flow Cytometry.
Measured: Baseline
Frequency of Natural Killer Cells as Measured With Flow Cytometry.
Measured: Day 5 postop
Frequency of Natural Killer Cells as Measured With Flow Cytometry.
Measured: Day 8 postop
Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry)
Measured: Baseline
Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry)
Measured: Day 5 postop
Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry)
Measured: Day 8 postop
Secondary outcomes (34)
Interferon Gamma
Measured: Baseline
Interferon Gamma
Measured: Day 5 postop
Interferon Gamma
Measured: Day 8 postop
Interleukin-2
Measured: Baseline
Interleukin-2
Measured: Day 5 postop
Interleukin-2
Measured: Day 8 postop
Interleukin-4
Measured: Baseline
Interleukin-4
Measured: Day 5 postop
Interleukin-4
Measured: Day 8 postop
Interleukin-6
Measured: Baseline
Interleukin-6
Measured: Day 5 postop
Interleukin-6
Measured: Day 8 postop
Interleukin-10
Measured: Baseline
Interleukin-10
Measured: Day 5 postop
Interleukin-10
Measured: Day 8 postop
TNF-Alpha
Measured: Baseline
TNF-Alpha
Measured: Day 5 postop
TNF-Alpha
Measured: Day 8 postop
Hemoglobin
Measured: Baseline
Hemoglobin
Measured: Day 1 postop
Hemoglobin
Measured: Day 5 postop
Hemoglobin
Measured: Day 8 postop
Erythrocyte Volume Fraction
Measured: Baseline
Erythrocyte Volume Fraction
Measured: Day 1 postop
Erythrocyte Volume Fraction
Measured: Day 5 postop
Erythrocyte Volume Fraction
Measured: Day 8 postop
Leucocyte Particle Concentration
Measured: Baseline
Leucocyte Particle Concentration
Measured: Day 1 postop
Leucocyte Particle Concentration
Measured: Day 5 postop
Leucocyte Particle Concentration
Measured: Day 8 postop
Lymphocytes
Measured: Baseline
Lymphocytes
Measured: Day 1 postop
Lymphocytes
Measured: Day 5 postop
Lymphocytes
Measured: Day 8 postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Arthroplasty, Replacement, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wellspect HealthCare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Magnus Jacobsson, MD, PhD, Prof., Study director, Dentsply Sirona Implants and Consumables
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00839241
- Sponsor's protocol ID
- YA-ABT-0004
- Status last verified
- Nov 2021
- First submitted
- 6 Feb 2009
- Last updated
- 11 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00839241
- Acronym / sponsor ID
- YA-ABT-0004
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Wellspect HealthCareIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 9 Feb 2009 (estimated)
- Results
- Posted 4 Oct 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous Blood Transfusion | Experimental | Device: Bellovac ABT |
| Allogenic Blood Transfusion | Active comparator | Procedure: Allogenic Blood Transfusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bellovac ABTBellovac ABT (autologous blood) | Device | Autologous Blood Transfusion |
| Allogenic Blood TransfusionTransfusion of allogenic ("bank") blood. | Procedure or surgery | Allogenic Blood Transfusion |
Primary outcome
Frequency of Natural Killer Cells as Measured With Flow Cytometry.
Time frame: Baseline
Frequency of Natural Killer Cells as Measured With Flow Cytometry.
Time frame: Day 5 postop
Frequency of Natural Killer Cells as Measured With Flow Cytometry.
Time frame: Day 8 postop
Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry)
Time frame: Baseline
Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry)
Time frame: Day 5 postop
Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry)
Time frame: Day 8 postop
34 secondary outcomes
Interferon Gamma
Time frame: Baseline
Interferon Gamma
Time frame: Day 5 postop
Interferon Gamma
Time frame: Day 8 postop
Interleukin-2
Time frame: Baseline
Interleukin-2
Time frame: Day 5 postop
Interleukin-2
Time frame: Day 8 postop
Interleukin-4
Time frame: Baseline
Interleukin-4
Time frame: Day 5 postop
Interleukin-4
Time frame: Day 8 postop
Interleukin-6
Time frame: Baseline
Interleukin-6
Time frame: Day 5 postop
Interleukin-6
Time frame: Day 8 postop
Interleukin-10
Time frame: Baseline
Interleukin-10
Time frame: Day 5 postop
Interleukin-10
Time frame: Day 8 postop
TNF-Alpha
Time frame: Baseline
TNF-Alpha
Time frame: Day 5 postop
TNF-Alpha
Time frame: Day 8 postop
Hemoglobin
Time frame: Baseline
Hemoglobin
Time frame: Day 1 postop
Hemoglobin
Time frame: Day 5 postop
Hemoglobin
Time frame: Day 8 postop
Erythrocyte Volume Fraction
Time frame: Baseline
Erythrocyte Volume Fraction
Time frame: Day 1 postop
Erythrocyte Volume Fraction
Time frame: Day 5 postop
Erythrocyte Volume Fraction
Time frame: Day 8 postop
Leucocyte Particle Concentration
Time frame: Baseline
Leucocyte Particle Concentration
Time frame: Day 1 postop
Leucocyte Particle Concentration
Time frame: Day 5 postop
Leucocyte Particle Concentration
Time frame: Day 8 postop
Lymphocytes
Time frame: Baseline
Lymphocytes
Time frame: Day 1 postop
Lymphocytes
Time frame: Day 5 postop
Lymphocytes
Time frame: Day 8 postop
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magnus Jacobsson, MD, PhD, Prof. study director
Dentsply Sirona Implants and Consumables
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bellovac ABT and Allogenic Blood Transfusion in people with Arthroplasty, Replacement, Knee and Blood Transfusion, Autologous, run by Wellspect HealthCare at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Oct 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Natural Killer Cells as Measured With Flow Cytometry. (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2021.