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Completed

NCT Number: NCT04505748

Is Self-transfusion Safe After Total Knee Arthroplasty in Terms of Nephrotoxicity of Gentamicin From Bone Cement?

Considering that the high local concentration of antibiotic from bone cement is delivered intravenously through the self-transfusion process, systematic toxicity has never been evaluated. In addition, the effectiveness of self-transfusion with the routine concomitant use of other modern blood-salvage strategies, like tranexamic acid, should be also assessed. Therefore we performed a randomized study to assess: 1) the safety of self-transfusion in TKA by comparing the gentamicin concentrations resulting from the use or not of autologous blood transfusion. 2) the efficacy of self-transfusion in TKA, with the concomitant administration of tranexamic acid.

The serum concentration of aminoglycosides has been measured in two groups of 20 patients each, after TKA, according to the use of self-transfusion. Hemoglobin, renal function and calculated blood loss were compared at several time points between groups.

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Key information

Conditions

Arthroplasty Complications Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Total Knee Arthroplasty

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University General Hospital of Alexandroupolis

Alexandroupoli, Evros, 68100, Greece

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • end-stage of knee osteoarthritis, who scheduled for unilateral primary TKA in our department

Exclusion criteria

  • patients who had been treated with gentamicin within the past 10 days
  • known allergies against the bone cement
  • estimated glomerular filtration rate (eGFR) <30ml/minute
  • previous nephrectomy and history of renal transplant
  • contraindications against tranexamic acid

Treatment and study plan

Self-transfusion device

Device

The Transfusion filter set for salvaged blood (Summit Medical Ltd, Gloucestershire, UK) has been randomly used in 20 patients postoperatively. Patients, who received autologous blood, transfused with the collected amount of blood, only once, 6h postoperatively

Primary outcomes

  1. Gentamicin serum concentration

    Time frame: Postoperatively at: 1 hour, 6 hours, 7 hours, 24 hours and 48 hours.

    using a quantitative fluorescent polarizing immunoassay (FPIA) in the Biochemical analyzer

Sponsors and collaborators

Lead sponsor

University Hospital, Alexandroupolis

Other

Collaborators

  • Democritus University of Thrace

Registry information

Official study title

Is Serum Gentamicin Concentration Modified With Autologous Cell-saved Blood Transfusion After Total Knee Arthroplasty Using Tranexamic Acid: A Randomized Control Trial

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 10, 2020
Registry last updated
Aug 10, 2020

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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