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| Name | Class |
|---|---|
| Democritus University of Thrace | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-transfusion group | Experimental | Patients to whom a self-transfusion device has been used after total knee arthroplasty. |
|
| Control group | No Intervention | Patients to whom conventional drains have been used after total knee arthroplasty. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Athanasios Verceridis, PhD | Associate Professor of Orthopedics, School of Medicine, Democritus University of Thrace, Greece | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University General Hospital of Alexandroupolis | Alexandroupoli | Evros | 68100 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17032907 | Background | 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. | |
| 18622836 | Background | 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. |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 22249345 | Result | 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. |
| 33333277 | Derived | 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. |