blood transfusion osteoarthritits
Conditions
Interventions
An existing intervention will be investigated, autologous retransfusion
drainage with the Bellovac® ABT retransfusion system.
Sponsors
Medisch Centrum Haaglanden
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patients scheduled to undergo elective major orthopaedic surgery (hip, knee) - Male and non-pregnant female patients between 18-80 years of age. - Patients who signed the Ethics Committee approved specific Informed Consent Form prior to surgery.
Exclusion criteria
Exclusion criteria: - Patients with a major surgical procedure during the 12 weeks before the study-related operation. - No other used alternatives to reduce allogeneic blood transfusions, such as preoperative epoetin alpha (Eprex®) injections or intra-operative cell saving (Sangvia®). - Clinical or laboratory evidence of untreated iron, folate or vitamin B12 deficiency. - Recent Myocardial Infarction or CVA (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the amount of allogeneic blood transfusions in the three groups. Allogeneic blood transfusions are given by specific haemoglobin levels. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are haemoglobin levels in the perioperative period, and complications with special focus on wound problems after surgery. Furthermore, all clinical data will be collected such as length of hospitalisation, co morbidity and others. | — |
Countries
Netherlands
Outcome results
None listed