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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00839241
Other study ID # YA-ABT-0004
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2009
Est. completion date June 2009

Study information

Verified date November 2021
Source Wellspect HealthCare
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Device:
Bellovac ABT
Bellovac ABT (autologous blood)
Procedure:
Allogenic Blood Transfusion
Transfusion of allogenic ("bank") blood.

Locations

Country Name City State
Poland Specjalistyczny Szpital Im. Alfreda Sokolowskiego Szczecin

Sponsors (1)

Lead Sponsor Collaborator
Wellspect HealthCare

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of Natural Killer Cells as Measured With Flow Cytometry. Baseline
Primary Frequency of Natural Killer Cells as Measured With Flow Cytometry. Day 5 postop
Primary Frequency of Natural Killer Cells as Measured With Flow Cytometry. Day 8 postop
Primary Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry) Baseline
Primary Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry) Day 5 postop
Primary Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry) Day 8 postop
Secondary Interferon Gamma Baseline
Secondary Interferon Gamma Day 5 postop
Secondary Interferon Gamma Day 8 postop
Secondary Interleukin-2 Baseline
Secondary Interleukin-2 Day 5 postop
Secondary Interleukin-2 Day 8 postop
Secondary Interleukin-4 Baseline
Secondary Interleukin-4 Day 5 postop
Secondary Interleukin-4 Day 8 postop
Secondary Interleukin-6 Baseline
Secondary Interleukin-6 Day 5 postop
Secondary Interleukin-6 Day 8 postop
Secondary Interleukin-10 Baseline
Secondary Interleukin-10 Day 5 postop
Secondary Interleukin-10 Day 8 postop
Secondary TNF-Alpha Baseline
Secondary TNF-Alpha Day 5 postop
Secondary TNF-Alpha Day 8 postop
Secondary Hemoglobin Baseline
Secondary Hemoglobin Day 1 postop
Secondary Hemoglobin Day 5 postop
Secondary Hemoglobin Day 8 postop
Secondary Erythrocyte Volume Fraction Baseline
Secondary Erythrocyte Volume Fraction Day 1 postop
Secondary Erythrocyte Volume Fraction Day 5 postop
Secondary Erythrocyte Volume Fraction Day 8 postop
Secondary Leucocyte Particle Concentration Baseline
Secondary Leucocyte Particle Concentration Day 1 postop
Secondary Leucocyte Particle Concentration Day 5 postop
Secondary Leucocyte Particle Concentration Day 8 postop
Secondary Lymphocytes Baseline
Secondary Lymphocytes Day 1 postop
Secondary Lymphocytes Day 5 postop
Secondary Lymphocytes Day 8 postop
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