NCT04505748

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 10, 2020

Completed
Last Updated

August 10, 2020

Status Verified

August 1, 2020

Enrollment Period

6 months

First QC Date

August 3, 2020

Last Update Submit

August 6, 2020

Conditions

Arthroplasty ComplicationsTotal Knee Arthroplasty

Keywords

gentamicinself-transfusionblood losstoxicitytotal knee arthoplasty

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

Self-transfusion group

EXPERIMENTAL

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

Device: Self-transfusion device

Control group

NO INTERVENTION

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

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

Self-transfusion group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • end-stage of knee osteoarthritis, who scheduled for unilateral primary TKA in our department

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University General Hospital of Alexandroupolis

Alexandroupoli, Evros, 68100, Greece

Location

Related Publications (4)

  • 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.

    PMID: 17032907BACKGROUND

  • 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.

    PMID: 18622836BACKGROUND

  • 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.

    PMID: 22249345RESULT

  • 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.

    PMID: 33333277DERIVED

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Athanasios Verceridis, PhD

    Associate Professor of Orthopedics, School of Medicine, Democritus University of Thrace, Greece

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant of Orthopaedic Surgery

Study Record Dates

First Submitted

August 3, 2020

First Posted

August 10, 2020

Study Start

January 1, 2020

Primary Completion

June 30, 2020

Study Completion

August 1, 2020

Last Updated

August 10, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)