Revision of Total Hip ArthroplastyNCT05237830
Effectiveness of Intraoperative Cell Salvage in Aseptic Revision Total Hip Arthroplasty.
An observational study of Revision of Total Hip Arthroplasty, run by University of Liege at 1 site in Belgium.
Trial summary
Intraoperative cell salvage is an important measure of patient blood management but its effectiveness in patients undergoing revision total hip arthroplasty remains unclear. Over the last decade, we have used intraoperative cell salvage systematically in this group of patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Revision of Total Hip Arthroplasty
- What is being tested?
- Use of Cell Salvage in revision of total hip arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 140 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2011to 31 Jan 2022
- Phase
- Observational
- 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
Study population: Revision of arthroplasty was defined as the exchange of any component of the hip prosthesis.
Who may be able to join
- Eligible patients were adults undergoing elective aseptic revision of hip arthroplasty at the department of orthopedic surgery of the University Hospital of Liege between 01 January 2011 and 31 December 2020.
Who cannot join
- Patients undergoing revision for infection or with local malignancies were excluded from this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Intraoperative Cell Salvage in Aseptic Revision Total Hip Arthroplasty: a Single-center Retrospective Study
Intraoperative cell salvage is an important measure of patient blood management but its effectiveness in patients undergoing revision total hip arthroplasty remains unclear. Over the last decade, we have used intraoperative cell salvage systematically in this group of patients. However, since the use of cell salvage has a cost and requires additional resources, we decided to retrospectively investigate its usefulness in this particular indication.
- Conditions
- Revision of Total Hip Arthroplasty
- Being tested
- Use of Cell Salvage in revision of total hip arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of Cell Salvage in revision of total hip arthroplastyProcedure or surgery
The effective use of the cell saver was defined as the ability to re-transfuse at least 125 mL of re-suspended red blood cells with a hematocrit of 60 %.
| Study group | Role | What they receive |
|---|---|---|
| Use | Patients in whom the cell saver was effectively used Receives: Procedure: Use of Cell Salvage in revision of total hip arthroplasty | |
| Not Use | Patients in whom the cell saver wasn't effectively used Receives: Procedure: Use of Cell Salvage in revision of total hip arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cell savage use
The primary outcome was the proportion of patients in whom the cell saver was effectively used (%)
Measured: during the surgical procedure
Secondary outcomes (5)
Re-infused
Total volume of re-suspended blood re-infused (mL)
Measured: during the surgical procedure
Hemoglobin
Post-operative hemoglobin level (g/dL)
Measured: during the surgical procedure
Allogenic Transfusion
The need for allogenic blood transfusion (unit)
Measured: 7 days
Aspirated blood
The total volume of blood aspirated into the reservoir (mL)
Measured: during the surgical procedure
Fluid
The total amount of fluid infused (mL)
Measured: during the surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start1 Jan 2011
- Primary completion31 Dec 2021
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Revision of Total Hip ArthroplastyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Carella, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237830
- Sponsor's protocol ID
- Cell-salvage
- Status last verified
- Feb 2022
- First submitted
- 2 Feb 2022
- Last updated
- 14 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Greenky M, Shaner J, Rasouli MR, Han SB, Parvizi J, Hozack WJ. Intraoperative blood salvage in revision total hip arthroplasty: who benefits most? J Arthroplasty. 2014 Jun;29(6):1298-300. doi: 10.1016/j.arth.2013.12.009. Epub 2013 Dec 14.
PubMed 24412146Palmer AJR, Lloyd TD, Gibbs VN, Shah A, Dhiman P, Booth R, Murphy MF, Taylor AH, Kendrick BJL; collaborators. The role of intra-operative cell salvage in patient blood management for revision hip arthroplasty: a prospective cohort study. Anaesthesia. 2020 Apr;75(4):479-486. doi: 10.1111/anae.14989. Epub 2020 Feb 9.
PubMed 32037522Rigal JC, Riche VP, Tching-Sin M, Fronteau C, Huon JF, Cadiet J, Boukhari R, Vourc'h M, Rozec B. Cost of red blood cell transfusion; evaluation in a French academic hospital. Transfus Clin Biol. 2020 Nov;27(4):222-228. doi: 10.1016/j.tracli.2020.08.002. Epub 2020 Aug 15.
PubMed 32810606Goel R, Patel EU, Cushing MM, Frank SM, Ness PM, Takemoto CM, Vasovic LV, Sheth S, Nellis ME, Shaz B, Tobian AAR. Association of Perioperative Red Blood Cell Transfusions With Venous Thromboembolism in a North American Registry. JAMA Surg. 2018 Sep 1;153(9):826-833. doi: 10.1001/jamasurg.2018.1565.
PubMed 29898202Walsh TS, Palmer J, Watson D, Biggin K, Seretny M, Davidson H, Harkness M, Hay A. Multicentre cohort study of red blood cell use for revision hip arthroplasty and factors associated with greater risk of allogeneic blood transfusion. Br J Anaesth. 2012 Jan;108(1):63-71. doi: 10.1093/bja/aer326. Epub 2011 Oct 27.
PubMed 22037224
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Intraoperative Cell Salvage in Aseptic Revision Total Hip Arthroplasty: a Single-center Retrospective Study
- ClinicalTrials.gov ID
- NCT05237830
- Acronym / sponsor ID
- Cell-salvage
- Conditions
- Revision of Total Hip Arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 14 Feb 2022 (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.
Intraoperative cell salvage is an important measure of patient blood management but its effectiveness in patients undergoing revision total hip arthroplasty remains unclear. Over the last decade, we have used intraoperative cell salvage systematically in this group of patients. However, since the use of cell salvage has a cost and requires additional resources, we decided to retrospectively investigate its usefulness in this particular indication.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Use | – | Procedure: Use of Cell Salvage in revision of total hip arthroplastyPatients in whom the cell saver was effectively used |
| Not Use | – | Procedure: Use of Cell Salvage in revision of total hip arthroplastyPatients in whom the cell saver wasn't effectively used |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Revision of arthroplasty was defined as the exchange of any component of the hip prosthesis.
Key inclusion criteria (1 listed)
- Eligible patients were adults undergoing elective aseptic revision of hip arthroplasty at the department of orthopedic surgery of the University Hospital of Liege between 01 January 2011 and 31 December 2020.
Key exclusion criteria (1 listed)
- Patients undergoing revision for infection or with local malignancies were excluded from this study.
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 |
|---|---|---|
| Use of Cell Salvage in revision of total hip arthroplastyThe effective use of the cell saver was defined as the ability to re-transfuse at least 125 mL of re-suspended red blood cells with a hematocrit of 60 %. | Procedure or surgery | Not Use, Use |
Primary outcome
Cell savage use
Time frame: during the surgical procedure
The primary outcome was the proportion of patients in whom the cell saver was effectively used (%)
5 secondary outcomes
Re-infused
Time frame: during the surgical procedure
Hemoglobin
Time frame: during the surgical procedure
Allogenic Transfusion
Time frame: 7 days
Aspirated blood
Time frame: during the surgical procedure
Fluid
Time frame: during the surgical procedure
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 14 Feb 2022.
- Background: PubMed 24412146Greenky M, Shaner J, Rasouli MR, Han SB, Parvizi J, Hozack WJ. Intraoperative blood salvage in revision total hip arthroplasty: who benefits most? J Arthroplasty. 2014 Jun;29(6):1298-300. doi: 10.1016/j.arth.2013.12.009. Epub 2013 Dec 14.
- Background: PubMed 32037522Palmer AJR, Lloyd TD, Gibbs VN, Shah A, Dhiman P, Booth R, Murphy MF, Taylor AH, Kendrick BJL; collaborators. The role of intra-operative cell salvage in patient blood management for revision hip arthroplasty: a prospective cohort study. Anaesthesia. 2020 Apr;75(4):479-486. doi: 10.1111/anae.14989. Epub 2020 Feb 9.
- Background: PubMed 32810606Rigal JC, Riche VP, Tching-Sin M, Fronteau C, Huon JF, Cadiet J, Boukhari R, Vourc'h M, Rozec B. Cost of red blood cell transfusion; evaluation in a French academic hospital. Transfus Clin Biol. 2020 Nov;27(4):222-228. doi: 10.1016/j.tracli.2020.08.002. Epub 2020 Aug 15.
- Background: PubMed 29898202Goel R, Patel EU, Cushing MM, Frank SM, Ness PM, Takemoto CM, Vasovic LV, Sheth S, Nellis ME, Shaz B, Tobian AAR. Association of Perioperative Red Blood Cell Transfusions With Venous Thromboembolism in a North American Registry. JAMA Surg. 2018 Sep 1;153(9):826-833. doi: 10.1001/jamasurg.2018.1565.
- Background: PubMed 22037224Walsh TS, Palmer J, Watson D, Biggin K, Seretny M, Davidson H, Harkness M, Hay A. Multicentre cohort study of red blood cell use for revision hip arthroplasty and factors associated with greater risk of allogeneic blood transfusion. Br J Anaesth. 2012 Jan;108(1):63-71. doi: 10.1093/bja/aer326. Epub 2011 Oct 27.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Revision of Total Hip Arthroplasty, run by University of Liege at 1 site in Belgium.
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 1 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 14 Feb 2022. 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 Belgium. 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?
Cell savage use (time frame: during the surgical procedure). 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 NCT05237830, which also lists 5 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 14 Feb 2022.