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

Total Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04505748
• Other study ID #: 80/27-01-2017
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: August 1, 2020

Study information

• Verified date: August 2020
• Source: University Hospital, Alexandroupolis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 1, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty Complications
• Total Knee Arthroplasty

Intervention

Device:
• Self-transfusion 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

Locations

Country	Name	City	State
Greece	University General Hospital of Alexandroupolis	Alexandroupolis	Evros

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Alexandroupolis	Democritus University of Thrace

Country where clinical trial is conducted

Greece, 

References & Publications (3)

de Klaver PA, Hendriks JG, van Onzenoort HA, Schreurs BW, Touw DJ, Derijks LJ. Gentamicin serum concentrations in patients with gentamicin-PMMA beads for infected hip joints: a prospective observational cohort study. Ther Drug Monit. 2012 Feb;34(1):67-71. — View Citation

Parvizi J, Saleh KJ, Ragland PS, Pour AE, Mont MA. Efficacy of antibiotic-impregnated cement in total hip replacement. Acta Orthop. 2008 Jun;79(3):335-41. doi: 10.1080/17453670710015229. — View Citation

Patrick BN, Rivey MP, Allington DR. Acute renal failure associated with vancomycin- and tobramycin-laden cement in total hip arthroplasty. Ann Pharmacother. 2006 Nov;40(11):2037-42. Epub 2006 Oct 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gentamicin serum concentration	using a quantitative fluorescent polarizing immunoassay (FPIA) in the Biochemical analyzer	Postoperatively at: 1 hour, 6 hours, 7 hours, 24 hours and 48 hours.