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OpenTrials
Completed

NCT Number: NCT00822588

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University Vienna, Department of Orthopaedic Surgery, Vienna, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sangvia® System

Device

Sangvia® Intra- and Post-op System

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Wellspect HealthCare

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 14, 2009
Registry last updated
Oct 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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