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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04505748

Enrollment

Registered

2020-08-10

Start date

2020-01-01

Completion date

2020-08-01

Last updated

2020-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty Complications, Total Knee Arthroplasty

Keywords

gentamicin, self-transfusion, blood loss, toxicity, total knee arthoplasty

Brief 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.

Interventions

DEVICESelf-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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026