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")

Arthroplasty, Replacement, Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00839241
• Other study ID #: YA-ABT-0004
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee
• Blood Transfusion
• Blood Transfusion, Autologous

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