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

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Randomized, Controlled Trial of Retransfusion of Intra-operatively Collected Filtered Whole Blood in Total Hip Surgery

Conditions
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Arthroplasty, Replacement, Hip, Blood Transfusion, Blood Transfusion, Autologous

Intervention / Treatment
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* Device: Sangvia® System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Device: Sangvia® System<br>* Sangvia® Intra- and Post-op System<br>|
| No Intervention: 2<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants in Need for Bank Blood Transfusion | Bank blood transfusions were given in both groups after assessment of independent assessor, by using a transfusion trigger. All transfusions were recorded in a transfusion log and summarized at discharge. The total number of patients per group in need for any bank blood transfusion was compared. The participant were followed for the duration of hospital stay, an average of 6 days (SD 3 days) | At discharge |