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

Arthroplasty, Replacement, Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00822588
• Other study ID #: YA-DRA-0001
• Status: Completed
• Phase: N/A
• First received: January 13, 2009
• Last updated: September 27, 2012
• Start date: May 2009
• Est. completion date: June 2010

Study information

• Verified date: September 2012
• Source: Wellspect HealthCare
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: EthikkommissionNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Norway:National Committee for Medical and Health Research EthicsSpain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 227
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip
• Blood Transfusion
• Blood Transfusion, Autologous

Intervention

Device:
• Sangvia® System
Sangvia® Intra- and Post-op System

Locations

Country	Name	City	State
Austria	Medical University Vienna, Department of Orthopaedic Surgery	Vienna
Netherlands	Onze Lieve Vrouwe Gasthuis (OLVG)	Amsterdam
Netherlands	Reinier de Graaf Gasthuis (RdGG), afd. Orthopedie	Delft
Netherlands	MC Haaglanden, Orthopedic Dept.	The Hague
Norway	St. Olavs Hospital, Ortopedisk avdelning	Trondheim
Spain	Hospital Universitario Mar- Esperança (IMAS), Servicio de Anestesiología	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Wellspect HealthCare

Countries where clinical trial is conducted

Austria,  Netherlands,  Norway,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	At discharge	No