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

February 6, 2009
September 27, 2012
January 2009
July 2009   (final data collection date for primary outcome measure)
  • 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 ]
Frequency and proportion of Natural Killer cells as measured with Flow cytometry. [ Time Frame: Baseline, postoperative day 1, 5 and 8. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00839241 on ClinicalTrials.gov Archive Site
  • 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 ]
Interferon y, Interleukins 2, 4, 6 and 10, TNF-@ as measured with Flow cytometry. Hb, HCT, WBC (incl. diff) as per local standard. [ Time Frame: Baseline, postoperative day 1, 5 and 8. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Arthroplasty, Replacement, Knee
  • Blood Transfusion, Autologous
  • Blood Transfusion
  • Device: Bellovac ABT
    Bellovac ABT (autologous blood)
  • Procedure: Allogenic Blood Transfusion
    Transfusion of allogenic ("bank") blood.
  • Experimental: Autologous Blood Transfusion
    Intervention: Device: Bellovac ABT
  • Active Comparator: Allogenic Blood Transfusion
    Intervention: Procedure: Allogenic Blood Transfusion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
Not Provided
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT00839241
YA-ABT-0004
No
Wellspect HealthCare
Wellspect HealthCare
Not Provided
Study Director: Magnus Jacobsson, MD, PhD, Prof. Dentsply Implants
Wellspect HealthCare
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP