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")

NCT00839241 | Completed Results

• 1 other identifier: YA-ABT-0004
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arthroplasty, Replacement, Knee; Blood Transfusion, Autologous; Blood Transfusion

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (34)

• Interferon Gamma

  Baseline

• Interferon Gamma

  Day 5 postop

• Interferon Gamma

  Day 8 postop

• Interleukin-2

  Baseline

• Interleukin-2

  Day 5 postop

Study Arms (2)

Autologous Blood Transfusion

EXPERIMENTAL

Device: Bellovac ABT

Allogenic Blood Transfusion

ACTIVE COMPARATOR

Procedure: Allogenic Blood Transfusion

Interventions

Bellovac ABT DEVICE

Bellovac ABT (autologous blood)

Autologous Blood Transfusion

Allogenic Blood Transfusion PROCEDURE

Transfusion of allogenic ("bank") blood.

Allogenic Blood Transfusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wellspect HealthCare: lead

Study Sites (1)

Specjalistyczny Szpital Im. Alfreda Sokolowskiego

Szczecin, 70 891, Poland

Location

Results Point of Contact

• Title: Head of Clinical Research Area Health Care
• Organization: Astra Tech AB

+46317761000

Study Officials

• Magnus Jacobsson, MD, PhD, Prof.

  Dentsply Sirona Implants and Consumables

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2009
• First Posted: February 9, 2009
• Study Start: January 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: November 11, 2021
• Results First Posted: October 4, 2010

Record last verified: 2021-11

Locations

PL (1)