Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04505748
Status:
COMPLETED
Last Update Posted:
2020-08-10
First Post:
2020-08-03
Brief Title:
Is Self-transfusion Safe After Total Knee Arthroplasty in Terms of Nephrotoxicity of Gentamicin From Bone Cement
Sponsor:
University Hospital Alexandroupolis
Organization:
University Hospital Alexandroupolis
Study Overview
Official Title:
Is Serum Gentamicin Concentration Modified With Autologous Cell-saved Blood Transfusion After Total Knee Arthroplasty Using Tranexamic Acid A Randomized Control Trial
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None