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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")

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wellspect HealthCare
ClinicalTrials.gov Identifier:
NCT00839241
First received: February 6, 2009
Last updated: September 27, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention
Arthroplasty, Replacement, Knee
Blood Transfusion, Autologous
Blood Transfusion
 Device: Bellovac ABT
Procedure: Allogenic Blood Transfusion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wellspect HealthCare:

Primary Outcome Measures:
  • Frequency of Natural Killer Cells as Measured With Flow Cytometry. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Frequency of Natural Killer Cells as Measured With Flow Cytometry. [ Time Frame: Day 5 postop ] [ Designated as safety issue: No ]
  • Frequency of Natural Killer Cells as Measured With Flow Cytometry. [ Time Frame: Day 8 postop ] [ Designated as safety issue: No ]
  • Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry) [ Time Frame: Day 5 postop ] [ Designated as safety issue: No ]
  • Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry) [ Time Frame: Day 8 postop ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Interferon Gamma [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Interferon Gamma [ Time Frame: Day 5 postop ] [ Designated as safety issue: No ]
  • Interferon Gamma [ Time Frame: Day 8 postop ] [ Designated as safety issue: No ]
  • Interleukin-2 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Interleukin-2 [ Time Frame: Day 5 postop ] [ Designated as safety issue: No ]
  • Interleukin-2 [ Time Frame: Day 8 postop ] [ Designated as safety issue: No ]
  • Interleukin-4 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Interleukin-4 [ Time Frame: Day 5 postop ] [ Designated as safety issue: No ]
  • Interleukin-4 [ Time Frame: Day 8 postop ] [ Designated as safety issue: No ]
  • Interleukin-6 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Interleukin-6 [ Time Frame: Day 5 postop ] [ Designated as safety issue: No ]
  • Interleukin-6 [ Time Frame: Day 8 postop ] [ Designated as safety issue: No ]
  • Interleukin-10 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Interleukin-10 [ Time Frame: Day 5 postop ] [ Designated as safety issue: No ]
  • Interleukin-10 [ Time Frame: Day 8 postop ] [ Designated as safety issue: No ]
  • TNF-Alpha [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • TNF-Alpha [ Time Frame: Day 5 postop ] [ Designated as safety issue: No ]
  • TNF-Alpha [ Time Frame: Day 8 postop ] [ Designated as safety issue: No ]
  • Hemoglobin [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Hemoglobin [ Time Frame: Day 1 postop ] [ Designated as safety issue: No ]
  • Hemoglobin [ Time Frame: Day 5 postop ] [ Designated as safety issue: No ]
  • Hemoglobin [ Time Frame: Day 8 postop ] [ Designated as safety issue: No ]
  • Erythrocyte Volume Fraction [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Erythrocyte Volume Fraction [ Time Frame: Day 1 postop ] [ Designated as safety issue: No ]
  • Erythrocyte Volume Fraction [ Time Frame: Day 5 postop ] [ Designated as safety issue: No ]
  • Erythrocyte Volume Fraction [ Time Frame: Day 8 postop ] [ Designated as safety issue: No ]
  • Leucocyte Particle Concentration [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Leucocyte Particle Concentration [ Time Frame: Day 1 postop ] [ Designated as safety issue: No ]
  • Leucocyte Particle Concentration [ Time Frame: Day 5 postop ] [ Designated as safety issue: No ]
  • Leucocyte Particle Concentration [ Time Frame: Day 8 postop ] [ Designated as safety issue: No ]
  • Lymphocytes [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Lymphocytes [ Time Frame: Day 1 postop ] [ Designated as safety issue: No ]
  • Lymphocytes [ Time Frame: Day 5 postop ] [ Designated as safety issue: No ]
  • Lymphocytes [ Time Frame: Day 8 postop ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: January 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00839241

Locations
Poland
Specjalistyczny Szpital Im. Alfreda Sokolowskiego
Szczecin, Poland, 70 891
Sponsors and Collaborators
Wellspect HealthCare
Investigators
Study Director: Magnus Jacobsson, MD, PhD, Prof. Dentsply Implants
  More Information

No publications provided

Responsible Party: Wellspect HealthCare
ClinicalTrials.gov Identifier: NCT00839241     History of Changes
Other Study ID Numbers: YA-ABT-0004
Study First Received: February 6, 2009
Results First Received: July 19, 2010
Last Updated: September 27, 2012
Health Authority: Poland: Bioethics Committee

ClinicalTrials.gov processed this record on May 22, 2013