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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2020-08-01

Brief Summary

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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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Detailed Description

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Conditions

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Arthroplasty Complications Total Knee Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Self-transfusion group

Patients to whom a self-transfusion device has been used after total knee arthroplasty.

Group Type EXPERIMENTAL

Self-transfusion device

Intervention Type 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

Control group

Patients to whom conventional drains have been used after total knee arthroplasty.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No