Clinical trial NCT00822588: Comparison in Need for Bank Blood Between Patients Undergoing Total Hip Surgery That Either Receive Their Own Blood Back or Not
Official title: A Prospective, Randomized, Controlled Trial of Retransfusion of Intra-operatively Collected Filtered Whole Blood in Total Hip Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Replacement, Hip
Blood Transfusion
Blood Transfusion, Autologous
Lead sponsor: Wellspect HealthCare
Sponsor class: INDUSTRY
First posted: 2009-01-14
Enrollment: 227
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants in Need for Bank Blood Transfusion
timeFrame: At discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna, Department of Orthopaedic Surgery
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis (OLVG)
city: Delft
country: Netherlands
facility: Reinier de Graaf Gasthuis (RdGG), afd. Orthopedie
city: The Hague
country: Netherlands
facility: MC Haaglanden, Orthopedic Dept.
city: Trondheim
country: Norway
facility: St. Olavs Hospital, Ortopedisk avdelning
city: Barcelona
country: Spain
facility: Hospital Universitario Mar- Esperança (IMAS), Servicio de Anestesiología
Study officials:
affiliation: Onze Lieve Vrouwe Gasthuis (OLVG)
name: Rudolf Poolman, Dr.
role: STUDY_DIRECTOR
References:
citation: Thomassen BJ, Pilot P, Scholtes VA, Grohs JG, Holen K, Bisbe E, Poolman RW. Limit allogeneic blood use with routine re-use of patient's own blood: a prospective, randomized, controlled trial in total hip surgery. PLoS One. 2012;7(9):e44503. doi: 10.1371/journal.pone.0044503. Epub 2012 Sep 13.