Knee ArthropathyNCT04137484
Patient Blood Management Program in Total Hip or Total Knee Arthroplasty
An observational study of Knee Arthropathy and Hip Arthropathy, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Total hip and knee arthroplasty are among the most common surgical procedures for which blood transfusion is prescribed. Patient blood management program has been proposed to decrease the need for transfusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Arthropathy, Hip Arthropathy
- How many people
- 723 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2014to 1 Aug 2016
- 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: Patients from the flow chart of the Cross Iron Study (Anesthesiology. 2018 Oct;129(4):710-720 ) Included patients were all the patients scheduled for elective primary total hip or knee arthroplasty and assessed by an anesthesiologist involved in the Cross Iron Study.
Who may be able to join
- patient from the flow chart of the Cross Iron Study (Anesthesiology. 2018 Oct;129(4):710-720 )
- patient scheduled for elective primary total hip or knee arthroplasty
Who cannot join
- pregnancy patient,
- patient under 18 years old
- systemic infection
- bilateral arthroplasty
- revision arthroplasty,
- participation in a preoperative autologous donation program.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Patient Blood Management Program in Total Hip or Total Knee Arthroplasty
Total hip and knee arthroplasty are among the most common surgical procedures for which blood transfusion is prescribed. Patient blood management program has been proposed to decrease the need for transfusion. This program involve three pillars: preoperative improvement of erythropoiesis, intraoperative reduction of bleeding and postoperative management of anemia.
Among the different steps of this program, reduction of bleeding and optimization of anemia are gaining popularity, but preoperative improvement of erythropoiesis is underused. The preoperative step of the blood management program is not systematically used because it requires a complex organization, is considered expensive, and finally because the others available techniques to reduce blood transfusion are easier to implement.
The aim of this study was to assess, within a patient blood management program, the effectiveness of erythropoietin on reducing allogenic blood transfusion and anemia in patients requiring elective total hip or knee arthroplasty. "
Read the detailed description
This is a post-hoc analysis using part of the patients involved in the Cross Iron Study (Anesthesiology. 2018 Oct;129(4):710-720 ) Included patients were all the patients scheduled for elective primary total hip or knee arthroplasty and assessed by an anesthesiologist involved in the Cross Iron Study. Exclusion criteria were pregnancy, age under 18 years old, systemic infection, bilateral arthroplasty, revision arthroplasty, and participation in a preoperative autologous donation program.
This was a observational study. The patient blood management program included: erythropoietin with iron supplementation if preoperative hemoglobin was lower than 13 g/dl; tranexamic acid during surgery; intravenous iron postoperatively and use of prespecified thresholds for homologous blood transfusion. Blood transfusion and anemia were assessed until day 5 or discharge, whichever came first. Major thromboembolic or cardiovascular events were assessed during admission and one month after discharge.
- Conditions
- Knee Arthropathy, Hip Arthropathy
- Keywords
- Patient Blood Management Program, Transfusion, Postoperative anemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood transfusion induced by postoperative anemia at hospital discharge
Hemoglobin was systematically assessed during surgery and after surgery at day 1, day 3 and day 5 if still admitted. The Hb thresholds for homologous blood transfusion used during the intra- and postoperative period were 7 g/dl in healthy patients in the absence of physical activity, 8 to 9 g/dl in the presence of physical activity (early rehabilitation) or in patients with cardiovascular disease, and 10 g/dl in patients with cardiac or coronary insufficiency.
Measured: before the anesthesia consultation, the day before surgery, and after surgery at day 1, day 3 and day 5 if still admitted
Blood transfusion induced by postoperative anemia at hospital discharge
Hemoglobin was systematically assessed during surgery and after surgery at day 1, day 3 and day 5 if still admitted. The Hb thresholds for homologous blood transfusion used during the intra- and postoperative period were 7 g/dl in healthy patients in the absence of physical activity, 8 to 9 g/dl in the presence of physical activity (early rehabilitation) or in patients with cardiovascular disease, and 10 g/dl in patients with cardiac or coronary insufficiency.
Measured: before the anesthesia consultation, the day before surgery, and after surgery at day 1, day3 and day 5 if still admitted
Secondary outcomes (1)
Rate of major complications one month after surgery
Major complications including thromboembolic events, cardiac or respiratory failure, admission in intensive care unit, and death were reported on day 3, on day 5 if still admitted, and one month after surgery at the routine postoperative surgical consultation
Measured: admission in intensive care unit, and death were reported on day 3, on day 5 if still admitted, and one month after surgery at the routine postoperative surgical consultation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start1 Jul 2014
- Primary completion1 Aug 2014
- Study completion1 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthropathyStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- 723 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe BIBOULET, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04137484
- Sponsor's protocol ID
- RECHMPL19_0484
- Status last verified
- Mar 2020
- First submitted
- 14 Oct 2019
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Patient Blood Management Program in Total Hip or Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04137484
- Acronym / sponsor ID
- RECHMPL19_0484
- Conditions
- Knee Arthropathy, Hip Arthropathy
- Keywords
- Patient Blood Management Program, Transfusion, Postoperative anemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 723 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jul 2014 (actual)
- Primary completion
- 1 Aug 2014 (actual)
- Study completion
- 1 Aug 2016 (actual)
- First posted
- 24 Oct 2019 (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.
Total hip and knee arthroplasty are among the most common surgical procedures for which blood transfusion is prescribed. Patient blood management program has been proposed to decrease the need for transfusion. This program involve three pillars: preoperative improvement of erythropoiesis, intraoperative reduction of bleeding and postoperative management of anemia.
Among the different steps of this program, reduction of bleeding and optimization of anemia are gaining popularity, but preoperative improvement of erythropoiesis is underused. The preoperative step of the blood management program is not systematically used because it requires a complex organization, is considered expensive, and finally because the others available techniques to reduce blood transfusion are easier to implement.
The aim of this study was to assess, within a patient blood management program, the effectiveness of erythropoietin on reducing allogenic blood transfusion and anemia in patients requiring elective total hip or knee arthroplasty. "
Detailed description
This is a post-hoc analysis using part of the patients involved in the Cross Iron Study (Anesthesiology. 2018 Oct;129(4):710-720 ) Included patients were all the patients scheduled for elective primary total hip or knee arthroplasty and assessed by an anesthesiologist involved in the Cross Iron Study. Exclusion criteria were pregnancy, age under 18 years old, systemic infection, bilateral arthroplasty, revision arthroplasty, and participation in a preoperative autologous donation program.
This was a observational study. The patient blood management program included: erythropoietin with iron supplementation if preoperative hemoglobin was lower than 13 g/dl; tranexamic acid during surgery; intravenous iron postoperatively and use of prespecified thresholds for homologous blood transfusion. Blood transfusion and anemia were assessed until day 5 or discharge, whichever came first. Major thromboembolic or cardiovascular events were assessed during admission and one month after discharge.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from the flow chart of the Cross Iron Study (Anesthesiology. 2018 Oct;129(4):710-720 ) Included patients were all the patients scheduled for elective primary total hip or knee arthroplasty and assessed by an anesthesiologist involved in the Cross Iron Study.
Key inclusion criteria (2 listed)
- patient from the flow chart of the Cross Iron Study (Anesthesiology. 2018 Oct;129(4):710-720 )
- patient scheduled for elective primary total hip or knee arthroplasty
Key exclusion criteria (6 listed)
- pregnancy patient,
- patient under 18 years old
- systemic infection
- bilateral arthroplasty
- revision arthroplasty,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood transfusion induced by postoperative anemia at hospital discharge
Time frame: before the anesthesia consultation, the day before surgery, and after surgery at day 1, day 3 and day 5 if still admitted
Hemoglobin was systematically assessed during surgery and after surgery at day 1, day 3 and day 5 if still admitted. The Hb thresholds for homologous blood transfusion used during the intra- and postoperative period were 7 g/dl in healthy patients in the absence of physical activity, 8 to 9 g/dl in the presence of physical activity (early rehabilitation) or in patients with cardiovascular disease, and 10 g/dl in patients with cardiac or coronary insufficiency.
Blood transfusion induced by postoperative anemia at hospital discharge
Time frame: before the anesthesia consultation, the day before surgery, and after surgery at day 1, day3 and day 5 if still admitted
Hemoglobin was systematically assessed during surgery and after surgery at day 1, day 3 and day 5 if still admitted. The Hb thresholds for homologous blood transfusion used during the intra- and postoperative period were 7 g/dl in healthy patients in the absence of physical activity, 8 to 9 g/dl in the presence of physical activity (early rehabilitation) or in patients with cardiovascular disease, and 10 g/dl in patients with cardiac or coronary insufficiency.
1 secondary outcome
Rate of major complications one month after surgery
Time frame: admission in intensive care unit, and death were reported on day 3, on day 5 if still admitted, and one month after surgery at the routine postoperative surgical consultation
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 Mar 2020.
- Individual participant dataSharing planned: Undecided. NC
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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.
Philippe BIBOULET, MD principal investigator
University Hospital, Montpellier
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 Knee Arthropathy and Hip Arthropathy, run by University Hospital, Montpellier at 1 site in France.
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 6 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 Mar 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 France. 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?
Blood transfusion induced by postoperative anemia at hospital discharge (time frame: before the anesthesia consultation, the day before surgery, and after surgery at day 1, day 3 and day 5 if still admitted). The study lists 2 primary outcomes in all. 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 Mar 2020.