Status:
COMPLETED
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")
Lead Sponsor:
Wellspect HealthCare
Conditions:
Arthroplasty, Replacement, Knee
Blood Transfusion, Autologous
Eligibility:
All Genders
18+ years
Phase:
NA
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 cha...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00839241
Start Date
January 1 2009
End Date
June 1 2009
Last Update
November 11 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Specjalistyczny Szpital Im. Alfreda Sokolowskiego
Szczecin, Poland, 70 891