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

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ClinicalTrials.gov Identifier: NCT00822588
Recruitment Status : Completed
First Posted : January 14, 2009
Results First Posted : May 3, 2011
Last Update Posted : October 4, 2012
Sponsor:
Information provided by (Responsible Party):
Wellspect HealthCare

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.


Condition or disease Intervention/treatment Phase
Arthroplasty, Replacement, Hip Blood Transfusion Blood Transfusion, Autologous Device: Sangvia® System Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 227 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : May 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Device: Sangvia® System
Sangvia® Intra- and Post-op System
No Intervention: 2



Primary Outcome Measures :
  1. Number of Participants in Need for Bank Blood Transfusion [ Time Frame: At discharge ]

    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)




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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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)

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
First Posted: January 14, 2009    Key Record Dates
Results First Posted: May 3, 2011
Last Update Posted: October 4, 2012
Last Verified: September 2012