Arthroplasty, Replacement, Hip, Blood Transfusion, Blood Transfusion, Autologous
Conditions
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 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.
Interventions
DEVICESangvia® System
Sangvia® Intra- and Post-op System
Sponsors
Wellspect HealthCare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants in Need for Bank Blood Transfusion | At discharge | 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) |
Countries
Austria, Netherlands, Norway, Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sangvia Autologous blood transfusion with Sangvia device (routinely) | 106 |
| No Sangvia No autologous blood transfusion. | 110 |
| Total | 216 |
Baseline characteristics
| Characteristic | Sangvia | No Sangvia | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 62 Participants | 61 Participants | 123 Participants |
| Age, Categorical Between 18 and 65 years | 44 Participants | 49 Participants | 93 Participants |
| Age Continuous | 67 years STANDARD_DEVIATION 11 | 65 years STANDARD_DEVIATION 12 | 66 years STANDARD_DEVIATION 11 |
| Region of Enrollment Austria | 12 participants | 13 participants | 25 participants |
| Region of Enrollment Netherlands | 82 participants | 86 participants | 168 participants |
| Region of Enrollment Norway | 7 participants | 6 participants | 13 participants |
| Region of Enrollment Spain | 5 participants | 5 participants | 10 participants |
| Sex: Female, Male Female | 76 Participants | 70 Participants | 146 Participants |
| Sex: Female, Male Male | 30 Participants | 40 Participants | 70 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 12 / 106 | 9 / 110 |
| serious Total, serious adverse events | 7 / 106 | 7 / 110 |
Outcome results
Primary
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)
Time frame: At discharge
Population: Per protocol group. Major protocol deviations were excluded: Incorrect treatment, no treatment or exclusion criteria fulfilled.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sangvia | Number of Participants in Need for Bank Blood Transfusion | 9 Participants |
| No Sangvia | Number of Participants in Need for Bank Blood Transfusion | 13 Participants |