Clinical trial NCT00839241: 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")
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Blood Transfusion, Autologous
Blood Transfusion
Lead sponsor: Wellspect HealthCare
Sponsor class: INDUSTRY
First posted: 2009-02-09
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Frequency of Natural Killer Cells as Measured With Flow Cytometry.
timeFrame: Baseline
measure: Frequency of Natural Killer Cells as Measured With Flow Cytometry.
timeFrame: Day 5 postop
measure: Frequency of Natural Killer Cells as Measured With Flow Cytometry.
timeFrame: Day 8 postop
measure: Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry)
timeFrame: Baseline
measure: Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry)
timeFrame: Day 5 postop
measure: Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry)
timeFrame: Day 8 postop
Secondary outcomes:
measure: Interferon Gamma
timeFrame: Baseline
measure: Interferon Gamma
timeFrame: Day 5 postop
measure: Interferon Gamma
timeFrame: Day 8 postop
measure: Interleukin-2
timeFrame: Baseline
measure: Interleukin-2
timeFrame: Day 5 postop
measure: Interleukin-2
timeFrame: Day 8 postop
measure: Interleukin-4
timeFrame: Baseline
measure: Interleukin-4
timeFrame: Day 5 postop
measure: Interleukin-4
timeFrame: Day 8 postop
measure: Interleukin-6
timeFrame: Baseline
measure: Interleukin-6
timeFrame: Day 5 postop
measure: Interleukin-6
timeFrame: Day 8 postop
measure: Interleukin-10
timeFrame: Baseline
measure: Interleukin-10
timeFrame: Day 5 postop
measure: Interleukin-10
timeFrame: Day 8 postop
measure: TNF-Alpha
timeFrame: Baseline
measure: TNF-Alpha
timeFrame: Day 5 postop
measure: TNF-Alpha
timeFrame: Day 8 postop
measure: Hemoglobin
timeFrame: Baseline
measure: Hemoglobin
timeFrame: Day 1 postop
measure: Hemoglobin
timeFrame: Day 5 postop
measure: Hemoglobin
timeFrame: Day 8 postop
measure: Erythrocyte Volume Fraction
timeFrame: Baseline
measure: Erythrocyte Volume Fraction
timeFrame: Day 1 postop
measure: Erythrocyte Volume Fraction
timeFrame: Day 5 postop
measure: Erythrocyte Volume Fraction
timeFrame: Day 8 postop
measure: Leucocyte Particle Concentration
timeFrame: Baseline
measure: Leucocyte Particle Concentration
timeFrame: Day 1 postop
measure: Leucocyte Particle Concentration
timeFrame: Day 5 postop
measure: Leucocyte Particle Concentration
timeFrame: Day 8 postop
measure: Lymphocytes
timeFrame: Baseline
measure: Lymphocytes
timeFrame: Day 1 postop
measure: Lymphocytes
timeFrame: Day 5 postop
measure: Lymphocytes
timeFrame: Day 8 postop
Other outcomes:
Locations:
city: Szczecin
country: Poland
facility: Specjalistyczny Szpital Im. Alfreda Sokolowskiego
Study officials:
affiliation: Dentsply Sirona Implants and Consumables
name: Magnus Jacobsson, MD, PhD, Prof.
role: STUDY_DIRECTOR
References: