Total Hip ArthroplastyNCT01576263
Autologous Blood Transfusion After Local Infiltration
An observational study of Total Hip Arthroplasty and Total Knee Arthroplasty, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
Trial summary
Total knee and hip arthroplasty for osteoarthritis is performed on still broader indications even in elderly patients with previous or current medical conditions. Especially comorbidity like cardiovascular diseases and conditions with increased risk of bleeding or previous thrombo-embolic events are major challenges. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Hip Arthroplasty, Total Knee Arthroplasty
- What is being tested?
- Autologous blood transfusion with ropivacaine
- How many people
- 52 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2010to Jun 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic.
Who may be able to join
- Clinical diagnosis for hip arthroplasty
- Clinical diagnosis for knee arthroplasty
Who cannot join
- Patients < 18 years
- Lack of informed consent
- Inability to read/understand Danish
- Bilateral diagnosis
- Cancer diagnosis
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Vendsyssel Hospital, Frederikshavn, Aalborg Hospital, Aarhus University
Aalborg
About this study
Official title: Autologous Blood Transfusion After Local Infiltration Analgesia With Ropivacaine in Total Knee and Hip Arthroplasty
Total knee and hip arthroplasty for osteoarthritis is performed on still broader indications even in elderly patients with previous or current medical conditions. Especially comorbidity like cardiovascular diseases and conditions with increased risk of bleeding or previous thrombo-embolic events are major challenges.
To facilitate safe use of ropivacaine as an analgesic, information on the concentrations levels after autologous blood transfusion following local infiltration analgesia is very crucial. However, very limited data are available. To verify the safety of autologous blood transfusion, ropivacaine concentrations were studied in 52 patients undergoing either total knee arthroplasty or total hip arthroplasty.
- Conditions
- Total Hip Arthroplasty, Total Knee Arthroplasty
- Being tested
- Autologous blood transfusion with ropivacaine
- Keywords
- Anaesthesia, Infiltration, Blood transfusion, Autologous, Arthroplasty, Replacement, Ropivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous blood transfusion with ropivacaineDrug
Also called No other names.
Local infiltration analgesia with ropivacaine 3 mg/kg, max 200 mg
Autologous blood transfusion with ropivacaineDrug
Also called No other names.
Local infiltration analgesia with ropivacaine 3 mg/kg, max 200 mg.
| Study group | Role | What they receive |
|---|---|---|
| Total knee arthroplasty | 25 consecutive patients diagnosed for total knee arthroplasty. Receives: Drug: Autologous blood transfusion with ropivacaine | |
| Total hip arthroplasty | 27 patients diagnosed for total hip arthroplasty. Receives: Drug: Autologous blood transfusion with ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentrations of ropivacaine in serum
Concentrations of ropivacaine in serum before and after autologous blood transfusion will be analyzed.
Measured: 6 hours
Secondary outcomes (1)
Analysis of ECG and pulse rate
ECG, pulse rate and blood pressure will be analyzed in proportion to concentrations of serum before and after autologous blood transfusion
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2012 (estimated)
- Study startMar 2010
- Primary completionApr 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ole Simonsen, M.D., Principal investigator, Northern Orthopaedic Department, Aalborg University Hospital, DenmarkSten Rasmussen, M.D., Study chair, Northern Orthopaedic Division, Aalborg University Hospital, DenmarkBjarne B. Dencker, M.D., Study chair, Department of Anaesthesiology, Aalborg University Hospital, DenmarkTorben Breindahl, M.D., Study chair, Department of Clinical Biochemistry, Vendsyssel Hospital, Aarhus University, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01576263
- Sponsor's protocol ID
- N-20090061
- Status last verified
- Apr 2015
- First submitted
- 3 Apr 2012
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Blood Transfusion After Local Infiltration Analgesia With Ropivacaine in Total Knee and Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT01576263
- Acronym / sponsor ID
- N-20090061
- Conditions
- Total Hip Arthroplasty, Total Knee Arthroplasty
- Keywords
- Anaesthesia, Infiltration, Blood transfusion, Autologous, Arthroplasty, Replacement, Ropivacaine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 12 Apr 2012 (estimated)
- 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.
Total knee and hip arthroplasty for osteoarthritis is performed on still broader indications even in elderly patients with previous or current medical conditions. Especially comorbidity like cardiovascular diseases and conditions with increased risk of bleeding or previous thrombo-embolic events are major challenges.
To facilitate safe use of ropivacaine as an analgesic, information on the concentrations levels after autologous blood transfusion following local infiltration analgesia is very crucial. However, very limited data are available. To verify the safety of autologous blood transfusion, ropivacaine concentrations were studied in 52 patients undergoing either total knee arthroplasty or total hip arthroplasty.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total knee arthroplasty | – | Drug: Autologous blood transfusion with ropivacaine25 consecutive patients diagnosed for total knee arthroplasty. |
| Total hip arthroplasty | – | Drug: Autologous blood transfusion with ropivacaine27 patients diagnosed for total hip arthroplasty. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic.
Key inclusion criteria (2 listed)
- Clinical diagnosis for hip arthroplasty
- Clinical diagnosis for knee arthroplasty
Key exclusion criteria (5 listed)
- Patients < 18 years
- Lack of informed consent
- Inability to read/understand Danish
- Bilateral diagnosis
- Cancer diagnosis
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 |
|---|---|---|
| Autologous blood transfusion with ropivacaineAlso: No other names.Local infiltration analgesia with ropivacaine 3 mg/kg, max 200 mg | Drug | Total knee arthroplasty |
| Autologous blood transfusion with ropivacaineAlso: No other names.Local infiltration analgesia with ropivacaine 3 mg/kg, max 200 mg. | Drug | Total hip arthroplasty |
Primary outcome
Concentrations of ropivacaine in serum
Time frame: 6 hours
Concentrations of ropivacaine in serum before and after autologous blood transfusion will be analyzed.
1 secondary outcome
Analysis of ECG and pulse rate
Time frame: 6 hours
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 Apr 2015.
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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.
Ole Simonsen, M.D. principal investigator
Northern Orthopaedic Department, Aalborg University Hospital, Denmark
Sten Rasmussen, M.D. study chair
Northern Orthopaedic Division, Aalborg University Hospital, Denmark
Bjarne B. Dencker, M.D. study chair
Department of Anaesthesiology, Aalborg University Hospital, Denmark
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 Total Hip Arthroplasty and Total Knee Arthroplasty, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
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 2 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 Apr 2015. 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 Denmark. 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?
Concentrations of ropivacaine in serum (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2015; AzTrials last refreshed its copy on 6 Nov 2026.