NCT00839241CompletedNot Applicable
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
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Wellspect HealthCare
- Enrollment
- 45
- Locations
- 2
- Primary Endpoint
- Frequency of Natural Killer Cells as Measured With Flow Cytometry.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
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: Day 8 postop
Secondary Outcomes
- Interleukin-6(Day 8 postop)
- Interleukin-2(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)
Investigators
Study Sites (2)
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