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")
Not Applicable
Completed
- Conditions
- Blood Transfusion, AutologousBlood TransfusionArthroplasty, Replacement, Knee
- Registration Number
- NCT00839241
- Lead Sponsor
- Wellspect HealthCare
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Frequency of Natural Killer Cells as Measured With Flow Cytometry. Day 8 postop Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry) Day 8 postop
- Secondary Outcome Measures
Name Time Method Interleukin-6 Day 8 postop Erythrocyte Volume Fraction Day 8 postop Leucocyte Particle Concentration Day 8 postop Interleukin-4 Day 8 postop Interleukin-10 Day 8 postop TNF-Alpha Day 8 postop Hemoglobin Day 8 postop Interferon Gamma Day 8 postop Lymphocytes Day 8 postop Interleukin-2 Day 8 postop
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which autologous blood transfusion modulates NK cell activity post-total knee arthroplasty?
How does Bellovac® ABT compare to allogenic transfusion in immune function recovery after orthopedic surgery?
Which biomarkers correlate with improved immunological outcomes in autologous vs. allogenic transfusion strategies for knee replacement patients?
What adverse events are associated with postoperative autologous blood transfusion using Bellovac® systems in arthroplasty?
Are there combination therapies enhancing immunological benefits of autologous transfusion in joint replacement procedures?
Trial Locations
- Locations (1)
Specjalistyczny Szpital Im. Alfreda Sokolowskiego
🇵🇱Szczecin, Poland
Specjalistyczny Szpital Im. Alfreda Sokolowskiego🇵🇱Szczecin, Poland