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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wellspect HealthCare
ClinicalTrials.gov Identifier:
NCT00822588
First received: January 13, 2009
Last updated: September 27, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Arthroplasty, Replacement, Hip
Blood Transfusion
Blood Transfusion, Autologous
Device: Sangvia® System

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled Trial of Retransfusion of Intra-operatively Collected Filtered Whole Blood in Total Hip Surgery

Resource links provided by NLM:


Further study details as provided by Wellspect HealthCare:

Primary Outcome Measures:
  • Number of Participants in Need for Bank Blood Transfusion [ Time Frame: At discharge ] [ Designated as safety issue: No ]

    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)



Enrollment: 227
Study Start Date: May 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Device: Sangvia® System
Sangvia® Intra- and Post-op System
No Intervention: 2

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00822588

Locations
Austria
Medical University Vienna, Department of Orthopaedic Surgery
Vienna, Austria, 1090
Netherlands
Onze Lieve Vrouwe Gasthuis (OLVG)
Amsterdam, Netherlands, 1091 HA
Reinier de Graaf Gasthuis (RdGG), afd. Orthopedie
Delft, Netherlands, 2600 GA
MC Haaglanden, Orthopedic Dept.
The Hague, Netherlands, 2501 CK
Norway
St. Olavs Hospital, Ortopedisk avdelning
Trondheim, Norway, 7006
Spain
Hospital Universitario Mar- Esperança (IMAS), Servicio de Anestesiología
Barcelona, Spain, 08003
Sponsors and Collaborators
Wellspect HealthCare
Investigators
Study Director: Rudolf Poolman, Dr. Onze Lieve Vrouwe Gasthuis (OLVG)
  More Information

No publications provided by Wellspect HealthCare

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wellspect HealthCare
ClinicalTrials.gov Identifier: NCT00822588     History of Changes
Other Study ID Numbers: YA-DRA-0001
Study First Received: January 13, 2009
Results First Received: February 18, 2011
Last Updated: September 27, 2012
Health Authority: Austria: Ethikkommission
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Norway:National Committee for Medical and Health Research Ethics
Spain: Comité Ético de Investigación Clínica

ClinicalTrials.gov processed this record on August 28, 2014