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

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

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.

Study Overview

• Status: Completed
• Conditions: Blood Transfusion; Arthroplasty, Replacement, Hip; Blood Transfusion, Autologous
• Intervention / Treatment: Device: Sangvia® System

• Study Type: Interventional
• Enrollment (Actual): 227
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medical University Vienna, Department of Orthopaedic Surgery
• Netherlands
  • Amsterdam, Netherlands, 1091 HA
    • Onze Lieve Vrouwe Gasthuis (OLVG)
  • Delft, Netherlands, 2600 GA
    • Reinier de Graaf Gasthuis (RdGG), afd. Orthopedie
  • The Hague, Netherlands, 2501 CK
    • MC Haaglanden, Orthopedic Dept.
• Norway
  • Trondheim, Norway, 7006
    • St. Olavs Hospital, Ortopedisk avdelning
• Spain
  • Barcelona, Spain, 08003
    • Hospital Universitario Mar- Esperança (IMAS), Servicio de Anestesiología

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Device: Sangvia® System; Sangvia® Intra- and Post-op System
No Intervention: 2

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wellspect HealthCare
• Investigators: Study Director: Rudolf Poolman, Dr., Onze Lieve Vrouwe Gasthuis (OLVG)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: January 13, 2009
• First Submitted That Met QC Criteria: January 13, 2009
• First Posted (Estimate): January 14, 2009

Study Record Updates

• Last Update Posted (Estimate): October 4, 2012
• Last Update Submitted That Met QC Criteria: September 27, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: YA-DRA-0001