CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
Self-transfusion devicedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04505748
NCT04505748N/ACompleted

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

University Hospital, Alexandroupolis·interventional·Posted Aug 10, 2020·Updated Aug 10, 2020

In Brief

A clinical study evaluating Self-transfusion device for Arthroplasty Complications and Total Knee Arthroplasty. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGreece

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedAug 10, 2020
Enrollment StartJan 1, 2020
Primary CompletionJun 30, 2020
Study CompletionAug 1, 2020
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 5.9 years ago

Interventions

Self-transfusion devicedevice

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