Arthroplasty ComplicationsNCT04505748
Is Self-transfusion Safe After Total Knee Arthroplasty in Terms of Nephrotoxicity of Gentamicin From Bone Cement?
A study testing Self-transfusion device in people with Arthroplasty Complications and Total Knee Arthroplasty, run by University Hospital, Alexandroupolis at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthroplasty Complications, Total Knee Arthroplasty
- What is being tested?
- Self-transfusion device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jan 2020to 1 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- end-stage of knee osteoarthritis, who scheduled for unilateral primary TKA in our department
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Greece1 site
University General Hospital of Alexandroupolis
Alexandroupoli, Evros, 68100
About this study
Official title: Is Serum Gentamicin Concentration Modified With Autologous Cell-saved Blood Transfusion After Total Knee Arthroplasty Using Tranexamic Acid: A Randomized Control Trial
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.
- Being tested
- Self-transfusion device
- Keywords
- gentamicin, self-transfusion, blood loss, toxicity, total knee arthoplasty
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Self-transfusion group | Experimental | Patients to whom a self-transfusion device has been used after total knee arthroplasty. Receives: Device: Self-transfusion device |
| Control group | No intervention | Patients to whom conventional drains have been used after total knee arthroplasty. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gentamicin serum concentration
using a quantitative fluorescent polarizing immunoassay (FPIA) in the Biochemical analyzer
Measured: Postoperatively at: 1 hour, 6 hours, 7 hours, 24 hours and 48 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start1 Jan 2020
- Primary completion30 Jun 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Alexandroupolis
- Sponsor type
- University, hospital or other
- Collaborators
- Democritus University of Thrace
- Responsible party
- Principal investigator, Panagiotis Touzopoulos, University Hospital, Alexandroupolis
- Investigators
- Athanasios Verceridis, PhD, Study director, Associate Professor of Orthopedics, School of Medicine, Democritus University of Thrace, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04505748
- Sponsor's protocol ID
- 80/27-01-2017
- Status last verified
- Aug 2020
- First submitted
- 3 Aug 2020
- Last updated
- 10 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17032907Parvizi 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.
PubMed 18622836de 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.
PubMed 22249345Touzopoulos 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.
PubMed 33333277
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Serum Gentamicin Concentration Modified With Autologous Cell-saved Blood Transfusion After Total Knee Arthroplasty Using Tranexamic Acid: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04505748
- Acronym / sponsor ID
- 80/27-01-2017
- Keywords
- gentamicin, self-transfusion, blood loss, toxicity, total knee arthoplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, AlexandroupolisUniversity, hospital or other
- Collaborators
- Democritus University of Thrace
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 10 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-transfusion group | Experimental | Device: Self-transfusion devicePatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- end-stage of knee osteoarthritis, who scheduled for unilateral primary TKA in our department
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-transfusion deviceThe 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 | Device | Self-transfusion group |
Primary outcome
Gentamicin serum concentration
Time frame: Postoperatively at: 1 hour, 6 hours, 7 hours, 24 hours and 48 hours.
using a quantitative fluorescent polarizing immunoassay (FPIA) in the Biochemical analyzer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2020.
- Background: PubMed 17032907Patrick 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.
- Background: PubMed 18622836Parvizi 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.
- Results publication: PubMed 22249345de 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.
- Derived from this study: PubMed 33333277Touzopoulos 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Athanasios Verceridis, PhD study director
Associate Professor of Orthopedics, School of Medicine, Democritus University of Thrace, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-transfusion device in people with Arthroplasty Complications and Total Knee Arthroplasty, run by University Hospital, Alexandroupolis at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gentamicin serum concentration (time frame: Postoperatively at: 1 hour, 6 hours, 7 hours, 24 hours and 48 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04505748, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2020.