Status:
COMPLETED
Comparison in Need for Bank Blood Between Patients Undergoing Total Hip Surgery That Either Receive Their Own Blood Back or Not
Lead Sponsor:
Wellspect HealthCare
Conditions:
Arthroplasty, Replacement, Hip
Blood Transfusion
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study is a prospective, controlled, randomised and assessor blind study that investigate if the need for bank blood transfusion could be reduced in patients, undergoing primary or revision total h...
Eligibility Criteria
Inclusion
- Provision of informed consent
- Scheduled for primary or secondary, cemented or non-cemented, total hip arthroplasty
- 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)
- Previous enrollment or randomisation of treatment in the present study
- Expected or confirmed participation in another clinical study, that may interfere with the present study, during the study period
- Suspected severe non-compliance to protocol as judged by the investigator
- Current symptoms of haemophilia
- Current symptoms of hyperkalaemia
- Current symptoms of systemic infection or local infection in the operation field
- Current symptoms of impaired renal function including creatinine/clearance levels above the normal reference values
- 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), i.e. Hb concentration \< 11 g/dl (7 mmol/l)
- Use of recombinant erythopoetin
- Use of aprotinin and/or fibrin sealant
- Use of other autologous blood transfusion than that with the Sangvia® system (e.g. CellSaver, pre-donation, acute normovolemic haemodilution etc.)
- Women of childbearing age
- Fractures
- Revision/secondary total hip surgery with expected serious bone grafting
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
227 Patients enrolled
Trial Details
Trial ID
NCT00822588
Start Date
May 1 2009
End Date
June 1 2010
Last Update
October 4 2012
Active Locations (6)
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1
Medical University Vienna, Department of Orthopaedic Surgery
Vienna, Austria, 1090
2
Onze Lieve Vrouwe Gasthuis (OLVG)
Amsterdam, Netherlands, 1091 HA
3
Reinier de Graaf Gasthuis (RdGG), afd. Orthopedie
Delft, Netherlands, 2600 GA
4
MC Haaglanden, Orthopedic Dept.
The Hague, Netherlands, 2501 CK