Anemia (Diagnosis)pbm-hipNCT04398238
Transfusion Rates in Total Hip Replacement Before/After the Implementation of a Patient Blood Management Program.
An observational study of Anemia (Diagnosis) and Iron-deficiency, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
Retrospective observational study: impact of a peri-operative patient blood management program (PBM) on transfusion rates of patients undergoing elective hip replacement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia (Diagnosis), Iron-deficiency, Transfusion
- What is being tested?
- evaluation by transfusion medicine specialist
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2021to 4 Apr 2023
- 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: All patients of age > 18 who undergo screening and surgery for hip athroplasty in the selected time-frame
Who may be able to join
- undergoing elective hip replacement in the selected time-frame
- American Society of Anesthesiology (ASA) status 1-2-3
- age >18
Who cannot join
- patients not undergoing screening as outpatients at pre-operative clinic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Change in Transfusion Rates of Patients Undergoing Elective Total Hip Replacement Before/After the Implementation of a Peri-operative Patient Blood Management Program: a Retrospective Observational Study.
Retrospective observational study: impact of a peri-operative patient blood management program (PBM) on transfusion rates of patients undergoing elective hip replacement.
Read the detailed description
A Patient Blood Management (PBM) program was implemented in year 2019 in our institution: patient scheduled for elective total hip replacement underwent pre-operative screening about one month before surgery, and those with pre-operative hemoglobin < 13 g/dl were screened for possible causes and treatment of anemia.
Data from two different time frames, before and after the implementation of the program, were collected to study the change in clinical outcomes such as transfusion rates, length of stay, etc.
- Conditions
- Anemia (Diagnosis), Iron-deficiency, Transfusion, Arthroplasty
- Being tested
- evaluation by transfusion medicine specialist
- Keywords
- patient blood management, anemia, Arthroplasty
- Medical subject headings
- Anemia, Disease, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evaluation by transfusion medicine specialistCombination product
screening for anemia causes and treatment: iron/folate/vitamin B12 supplementation, Erythropoietin administration if indicated
| Study group | Role | What they receive |
|---|---|---|
| Pre-PBM | patients screened for surgery before the implementation of PBM program: pre-operative evaluation and treatment according to usual care | |
| post-PBM | patients screened for surgery after the implementation of PBM program (3 months allowed for training/optimization): all patients with pre-operative hemoglobin < 13g/dl undergo screening for causes and treatment as needed. Receives: Combination Product: evaluation by transfusion medicine specialist |
What is being measured
The primary outcome is the main question the study is designed to answer.
transfusion rates
percentage of patients undergoing hip replacement who receive at least one unit of concentrated red cells during or after surgery
Measured: from day of surgery till day of discharge, up to 60 days
Secondary outcomes (3)
minimum hemoglobin
minimum hemoglobin reached after surgery
Measured: from day of surgery till day of discharge, up to 60 days
hemoglobin at discharge
last measured hemoglobin before discharge from hospital
Measured: from day of surgery till day of discharge, up to 60 days
length of stay
total days of hospital stay from admission to discharge
Measured: from day of surgery till day of discharge, up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start1 Aug 2021
- Primary completion25 Nov 2022
- Study completion4 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anemia (Diagnosis)Studies 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
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefano Bonarelli, MD, Principal investigator, Istituto Ortopedico RizzoliSandra Giannone, MD, Study chair, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398238
- Sponsor's protocol ID
- 346/2020/Oss/IOR
- Acronym
- pbm-hip
- Status last verified
- May 2023
- First submitted
- 12 May 2020
- Last updated
- 30 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ellermann I, Bueckmann A, Eveslage M, Buddendick H, Latal T, Niehoff D, Geissler RG, Hempel G, Kerkhoff A, Berdel WE, Roeder N, Van Aken HK, Zarbock A, Steinbicker AU. Treating Anemia in the Preanesthesia Assessment Clinic: Results of a Retrospective Evaluation. Anesth Analg. 2018 Nov;127(5):1202-1210. doi: 10.1213/ANE.0000000000003583.
PubMed 29944518Munoz M, Acheson AG, Auerbach M, Besser M, Habler O, Kehlet H, Liumbruno GM, Lasocki S, Meybohm P, Rao Baikady R, Richards T, Shander A, So-Osman C, Spahn DR, Klein AA. International consensus statement on the peri-operative management of anaemia and iron deficiency. Anaesthesia. 2017 Feb;72(2):233-247. doi: 10.1111/anae.13773. Epub 2016 Dec 20.
PubMed 27996086Rineau E, Chaudet A, Chassier C, Bizot P, Lasocki S. Implementing a blood management protocol during the entire perioperative period allows a reduction in transfusion rate in major orthopedic surgery: a before-after study. Transfusion. 2016 Mar;56(3):673-81. doi: 10.1111/trf.13468. Epub 2016 Jan 8.
PubMed 26748489
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Change in Transfusion Rates of Patients Undergoing Elective Total Hip Replacement Before/After the Implementation of a Peri-operative Patient Blood Management Program: a Retrospective Observational Study.
- ClinicalTrials.gov ID
- NCT04398238
- Acronym / sponsor ID
- pbm-hip / 346/2020/Oss/IOR
- Conditions
- Anemia (Diagnosis), Iron-deficiency, Transfusion, Arthroplasty
- Keywords
- patient blood management, anemia, Arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 25 Nov 2022 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 21 May 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.
Retrospective observational study: impact of a peri-operative patient blood management program (PBM) on transfusion rates of patients undergoing elective hip replacement.
Detailed description
A Patient Blood Management (PBM) program was implemented in year 2019 in our institution: patient scheduled for elective total hip replacement underwent pre-operative screening about one month before surgery, and those with pre-operative hemoglobin < 13 g/dl were screened for possible causes and treatment of anemia.
Data from two different time frames, before and after the implementation of the program, were collected to study the change in clinical outcomes such as transfusion rates, length of stay, etc.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-PBM | – | –patients screened for surgery before the implementation of PBM program: pre-operative evaluation and treatment according to usual care |
| post-PBM | – | Combination Product: evaluation by transfusion medicine specialistpatients screened for surgery after the implementation of PBM program (3 months allowed for training/optimization): all patients with pre-operative hemoglobin < 13g/dl undergo screening for causes and treatment as needed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients of age > 18 who undergo screening and surgery for hip athroplasty in the selected time-frame
Key inclusion criteria (3 listed)
- undergoing elective hip replacement in the selected time-frame
- American Society of Anesthesiology (ASA) status 1-2-3
- age >18
Key exclusion criteria (1 listed)
- patients not undergoing screening as outpatients at pre-operative clinic
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 |
|---|---|---|
| evaluation by transfusion medicine specialistscreening for anemia causes and treatment: iron/folate/vitamin B12 supplementation, Erythropoietin administration if indicated | Combination product | post-PBM |
Primary outcome
transfusion rates
Time frame: from day of surgery till day of discharge, up to 60 days
percentage of patients undergoing hip replacement who receive at least one unit of concentrated red cells during or after surgery
3 secondary outcomes
minimum hemoglobin
Time frame: from day of surgery till day of discharge, up to 60 days
hemoglobin at discharge
Time frame: from day of surgery till day of discharge, up to 60 days
length of stay
Time frame: from day of surgery till day of discharge, up to 60 days
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 30 May 2023.
- Background: PubMed 29944518Ellermann I, Bueckmann A, Eveslage M, Buddendick H, Latal T, Niehoff D, Geissler RG, Hempel G, Kerkhoff A, Berdel WE, Roeder N, Van Aken HK, Zarbock A, Steinbicker AU. Treating Anemia in the Preanesthesia Assessment Clinic: Results of a Retrospective Evaluation. Anesth Analg. 2018 Nov;127(5):1202-1210. doi: 10.1213/ANE.0000000000003583.
- Background: PubMed 27996086Munoz M, Acheson AG, Auerbach M, Besser M, Habler O, Kehlet H, Liumbruno GM, Lasocki S, Meybohm P, Rao Baikady R, Richards T, Shander A, So-Osman C, Spahn DR, Klein AA. International consensus statement on the peri-operative management of anaemia and iron deficiency. Anaesthesia. 2017 Feb;72(2):233-247. doi: 10.1111/anae.13773. Epub 2016 Dec 20.
- Background: PubMed 26748489Rineau E, Chaudet A, Chassier C, Bizot P, Lasocki S. Implementing a blood management protocol during the entire perioperative period allows a reduction in transfusion rate in major orthopedic surgery: a before-after study. Transfusion. 2016 Mar;56(3):673-81. doi: 10.1111/trf.13468. Epub 2016 Jan 8.
- Individual participant dataSharing planned: Undecided
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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.
Stefano Bonarelli, MD principal investigator
Istituto Ortopedico Rizzoli
Sandra Giannone, MD study chair
Istituto Ortopedico Rizzoli
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 Anemia (Diagnosis) and Iron-deficiency, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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 3 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 30 May 2023. 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 Italy. 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?
transfusion rates (time frame: from day of surgery till day of discharge, up to 60 days). 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 NCT04398238, which also lists 3 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 30 May 2023.