Comparison in Need for Bank Blood Between Patients Undergoing Total Hip Surgery That Either Receive Their Own Blood Back or Not

Wellspect HealthCare

Status

Completed

Conditions

Arthroplasty, Replacement, Hip

Blood Transfusion, Autologous

Blood Transfusion

Treatments

Device: Sangvia® System

Study type

Interventional

Funder types

Industry

Identifiers

NCT00822588

YA-DRA-0001

Details and patient eligibility

About

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 hip replacement surgery, who receive their own blood back with the medical device Sangvia.

A comparison in need for bank blood will be made between patients that either receive their own blood back or not.

Enrollment

227 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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