Clinical trial NCT04505748: Is Self-transfusion Safe After Total Knee Arthroplasty in Terms of Nephrotoxicity of Gentamicin From Bone Cement?
Official title: Is Serum Gentamicin Concentration Modified With Autologous Cell-saved Blood Transfusion After Total Knee Arthroplasty Using Tranexamic Acid: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty Complications
Total Knee Arthroplasty
Keywords: gentamicin
self-transfusion
blood loss
toxicity
total knee arthoplasty
Lead sponsor: University Hospital, Alexandroupolis
Sponsor class: OTHER
Collaborators: name: Democritus University of Thrace
First posted: 2020-08-10
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Gentamicin serum concentration
timeFrame: Postoperatively at: 1 hour, 6 hours, 7 hours, 24 hours and 48 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandroupolis
country: Greece
facility: University General Hospital of Alexandroupolis
state: Evros
Study officials:
affiliation: Associate Professor of Orthopedics, School of Medicine, Democritus University of Thrace, Greece
name: Athanasios Verceridis, PhD
role: STUDY_DIRECTOR
References:
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. doi: 10.1345/aph.1H173. Epub 2006 Oct 10.
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.
citation: 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. doi: 10.1097/FTD.0b013e31823d7b89.
citation: Touzopoulos P, Arvanitidis K, Filidou E, Tilkeridis K, Karanikas M, Kolios G, Ververidis A. Is serum gentamicin concentration modified with autologous cell-saved blood transfusion after total knee arthroplasty using tranexamic acid? A randomised control trial. Orthop Traumatol Surg Res. 2021 May;107(3):102794. doi: 10.1016/j.otsr.2020.102794. Epub 2020 Dec 14.