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")

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

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 Overview

• Status: Completed
• Conditions: Arthroplasty, Replacement, Knee; Blood Transfusion; Blood Transfusion, Autologous
• Intervention / Treatment: Device: Bellovac ABT; Procedure: Allogenic Blood Transfusion

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Szczecin, Poland, 70 891
    • Specjalistyczny Szpital im. Alfreda Sokolowskiego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Autologous Blood Transfusion	Device: Bellovac ABT; Bellovac ABT (autologous blood)
ACTIVE_COMPARATOR: Allogenic Blood Transfusion	Procedure: Allogenic Blood Transfusion; Transfusion of allogenic ("bank") blood.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency of Natural Killer Cells as Measured With Flow Cytometry.	Baseline
Frequency of Natural Killer Cells as Measured With Flow Cytometry.	Day 5 postop
Frequency of Natural Killer Cells as Measured With Flow Cytometry.	Day 8 postop
Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry)	Baseline
Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry)	Day 5 postop
Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry)	Day 8 postop

Secondary Outcome Measures

Outcome Measure	Time Frame
Hemoglobin	Baseline
Interferon Gamma	Baseline
Interferon Gamma	Day 5 postop
Interferon Gamma	Day 8 postop
Interleukin-2	Baseline
Interleukin-2	Day 5 postop
Interleukin-2	Day 8 postop
Interleukin-4	Baseline
Interleukin-4	Day 5 postop
Interleukin-4	Day 8 postop
Interleukin-6	Baseline
Interleukin-6	Day 5 postop
Interleukin-6	Day 8 postop
Interleukin-10	Baseline
Interleukin-10	Day 5 postop
Interleukin-10	Day 8 postop
TNF-Alpha	Baseline
TNF-Alpha	Day 5 postop
TNF-Alpha	Day 8 postop
Hemoglobin	Day 1 postop
Hemoglobin	Day 5 postop
Hemoglobin	Day 8 postop
Erythrocyte Volume Fraction	Baseline
Erythrocyte Volume Fraction	Day 1 postop
Erythrocyte Volume Fraction	Day 5 postop
Erythrocyte Volume Fraction	Day 8 postop
Leucocyte Particle Concentration	Baseline
Leucocyte Particle Concentration	Day 1 postop
Leucocyte Particle Concentration	Day 5 postop
Leucocyte Particle Concentration	Day 8 postop
Lymphocytes	Baseline
Lymphocytes	Day 1 postop
Lymphocytes	Day 5 postop
Lymphocytes	Day 8 postop

Collaborators and Investigators

• Sponsor: Wellspect HealthCare
• Investigators: Study Director: Magnus Jacobsson, MD, PhD, Prof., Dentsply Sirona Implants

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (ACTUAL): June 1, 2009
• Study Completion (ACTUAL): June 1, 2009

Study Registration Dates

• First Submitted: February 6, 2009
• First Submitted That Met QC Criteria: February 6, 2009
• First Posted (ESTIMATE): February 9, 2009

Study Record Updates

• Last Update Posted (ACTUAL): November 11, 2021
• Last Update Submitted That Met QC Criteria: November 10, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: YA-ABT-0004