Orthopaedic SurgeryIPECONCT07500350
The Influence of Perioperative Strategies on the Extent of in Orthopaedic Prosthetic Surgery
An observational study of Orthopaedic Surgery, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
To assess the extent of blood loss in prosthetic surgery, considering whether possible variables may influence, either positively or negatively, the extent of such loss. The assessment will be carried out by analysing parameters (haemoglobin - haematocrit) in the immediate preoperative period and then on days 1-3 and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Orthopaedic Surgery
- How many people
- 1,683 participants
- Where
- 1 siteItaly
- Study dates
- 8 Jul 2026to Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients of both sexes who have undergone total knee replacement (unilateral or bilateral), unicompartmental and total knee replacement (unilateral or bilateral), and total shoulder replacement.
Who may be able to join
- Adult patients in ASA Class I-II-III undergoing prosthetic surgery, as a first-time implant
Who cannot join
- Patients who did not receive tranexamic acid prophylaxis (pre-operative and post- operative doses) and are therefore not comparable with the vast majority of cases.
- Reintervention, as bleeding depends on a variable that is not constant, namely the initial implant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Milan, Milan
Elena Cittera, 00390283502224, elena.cittera@grupposandonato.it
About this study
Official title: Influence of Perioperative Strategies on the Extent of Total Blood Loss in Orthopaedic Prosthetic Surgery
To assess the extent of blood loss in prosthetic surgery, considering whether possible variables may influence, either positively or negatively, the extent of such loss. The assessment will be carried out by analysing parameters (haemoglobin - haematocrit) in the immediate preoperative period and then on days 1-3 and 7.
Numerous clinical studies have examined blood loss - both intraoperative and, above all, total blood loss - in shoulder, hip and knee replacement surgery.
Read more
Anaesthetic and surgical techniques, relevant medications, the use of pneumatic tourniquets and, more simply, intraoperative positioning, as well as blood-sparing and blood recovery methods, have been the subject of extensive literature. Our study aims to retrospectively evaluate a full year of prosthetic surgery, analysing all the factors involved in the search for a definitive answer regarding the best method for this purpose, if feasible [1,2,3,4,5].
Prior to admission, the patient undergoes a standardised series of tests, which also include a complete blood count, serum iron, transferrin and ferritin levels.
This series of tests concerning haematocrit and haematopoietic function is then repeated on the 1st, 3rd and 7th post-operative days to assess overall blood loss
. Patients of both sexes who have undergone total knee replacement (unilateral or bilateral), unicompartmental and total knee replacement (unilateral or bilateral), and total shoulder replacement.
The above patients operated on between January 2025 and December 2025 at the San Siro Clinic.
Read the detailed description
3.1 General objective To assess the extent of blood loss in prosthetic surgery, considering whether possible variables may influence, either positively or negatively, the extent of such loss. The primary objective is to evaluate the extent and variability of blood loss in comparison with the literature and in relation to the various intraoperative methods used.
The assessment will be carried out by analysing the parameters (haemoglobin - haematocrit) in the immediate preoperative period and then on days 1-3 and 7.
3.2 Primary objective The primary objective is to assess the extent and variability of blood loss in comparison with the literature and in relation to the various intraoperative techniques used.
The assessment will be carried out by analysing the parameters (haemoglobin - haematocrit) in the immediate preoperative period and then on days 1-3 and 7.
3.3 Secondary objectives
- Long stay: i.e. whether blood loss has, on any occasion, altered the post-operative course and/or delayed orthopaedic discharge
- General and/or local complications: such as the presence of haematomas, or a drop in haemoglobin levels requiring specific treatment and/or transfusions of packed red blood cells or plasma. This may also include difficulties with recovery, including delays in regaining the ability to walk and in overall recovery
- Transfusion of blood or blood products: to be considered a 'relative failure' in preoperative preparation and/or the perioperative course
- STUDY DESIGN This is a retrospective, observational, single-centre study involving patients who underwent orthopaedic prosthetic surgery (hip, knee and shoulder) at the IRCCS Istituto Clinico San Siro between January 2025 and December 2025, with clinical data collection. The study will be conducted in accordance with Good Clinical Practice guidelines.
- Conditions
- Orthopaedic Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| The sample size was calculated by considering the decline in haemoglobin from pre- operative to day | The sample size was calculated by considering the decline in haemoglobin from pre- operative to day 5 as the primary outcome of the study and planning to use a multiple linear regression model. We assume we wish to test the additional contribution of 4 further predictors indicating the type of technique used (Local Infiltration of Anaesthetics (LIA), application of an intraoperative pneumatic tourniquet, intraoperative recovery of blood loss, application of drainage) to an initial regression model that includes sex, age, ASAC risk class, and antiplatelet or anticoagulant therapy. The complete model therefore includes 8 regression coefficients. We wish to test whether adding these 4 predictors to the initial model results in an increase of at least 1% in the variance explained by the model. Considering a significance level (alpha) of 5% and a power of 90%, the required sample size is 1530. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to assess the extent and variability of blood loss in comparison with the literature and in relation to the various intraoperative techniques used. The assessment will be carried out by analysing the parameters (haemoglobin - hae
A likelihood ratio test will also be performed to assess whether the full model performs better in terms of explained variance compared to the initial model including sex, age, ASAC risk class, and antiplatelet or anticoagulant therapy. Furthermore, all model coefficients will be evaluated individually and together with their 95% confidence intervals to assess the presence of statistically differences between the various surgical techniques.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start8 Jul 2026
- Primary completionDec 2026 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopaedic SurgeryStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe 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
- 1,683 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giorgio Oriani, P.I., Principal investigator, IRCCS Laleazzi Sant Ambrogio Site San Siro Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500350
- Sponsor's protocol ID
- IPECO
- Acronym
- IPECO
- Status last verified
- Sep 2026
- First submitted
- 24 Mar 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Dr. Claudio Legnani is an Orthopaedic physician well involv ed in this field, and I want to take part with another expert
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Perioperative Strategies on the Extent of Total Blood Loss in Orthopaedic Prosthetic Surgery
- ClinicalTrials.gov ID
- NCT07500350
- Acronym / sponsor ID
- IPECO / IPECO
- Conditions
- Orthopaedic Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,683 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 8 Jul 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 30 Mar 2026 (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.
To assess the extent of blood loss in prosthetic surgery, considering whether possible variables may influence, either positively or negatively, the extent of such loss. The assessment will be carried out by analysing parameters (haemoglobin - haematocrit) in the immediate preoperative period and then on days 1-3 and 7.
Numerous clinical studies have examined blood loss - both intraoperative and, above all, total blood loss - in shoulder, hip and knee replacement surgery.
Anaesthetic and surgical techniques, relevant medications, the use of pneumatic tourniquets and, more simply, intraoperative positioning, as well as blood-sparing and blood recovery methods, have been the subject of extensive literature. Our study aims to retrospectively evaluate a full year of prosthetic surgery, analysing all the factors involved in the search for a definitive answer regarding the best method for this purpose, if feasible [1,2,3,4,5].
Prior to admission, the patient undergoes a standardised series of tests, which also include a complete blood count, serum iron, transferrin and ferritin levels.
This series of tests concerning haematocrit and haematopoietic function is then repeated on the 1st, 3rd and 7th post-operative days to assess overall blood loss
. Patients of both sexes who have undergone total knee replacement (unilateral or bilateral), unicompartmental and total knee replacement (unilateral or bilateral), and total shoulder replacement.
The above patients operated on between January 2025 and December 2025 at the San Siro Clinic.
Detailed description
3.1 General objective To assess the extent of blood loss in prosthetic surgery, considering whether possible variables may influence, either positively or negatively, the extent of such loss. The primary objective is to evaluate the extent and variability of blood loss in comparison with the literature and in relation to the various intraoperative methods used.
The assessment will be carried out by analysing the parameters (haemoglobin - haematocrit) in the immediate preoperative period and then on days 1-3 and 7.
3.2 Primary objective The primary objective is to assess the extent and variability of blood loss in comparison with the literature and in relation to the various intraoperative techniques used.
The assessment will be carried out by analysing the parameters (haemoglobin - haematocrit) in the immediate preoperative period and then on days 1-3 and 7.
3.3 Secondary objectives
- Long stay: i.e. whether blood loss has, on any occasion, altered the post-operative course and/or delayed orthopaedic discharge
- General and/or local complications: such as the presence of haematomas, or a drop in haemoglobin levels requiring specific treatment and/or transfusions of packed red blood cells or plasma. This may also include difficulties with recovery, including delays in regaining the ability to walk and in overall recovery
- Transfusion of blood or blood products: to be considered a 'relative failure' in preoperative preparation and/or the perioperative course
- STUDY DESIGN This is a retrospective, observational, single-centre study involving patients who underwent orthopaedic prosthetic surgery (hip, knee and shoulder) at the IRCCS Istituto Clinico San Siro between January 2025 and December 2025, with clinical data collection. The study will be conducted in accordance with Good Clinical Practice guidelines.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The sample size was calculated by considering the decline in haemoglobin from pre- operative to day | – | –The sample size was calculated by considering the decline in haemoglobin from pre- operative to day 5 as the primary outcome of the study and planning to use a multiple linear regression model. We assume we wish to test the additional contribution of 4 further predictors indicating the type of technique used (Local Infiltration of Anaesthetics (LIA), application of an intraoperative pneumatic tourniquet, intraoperative recovery of blood loss, application of drainage) to an initial regression model that includes sex, age, ASAC risk class, and antiplatelet or anticoagulant therapy. The complete model therefore includes 8 regression coefficients. We wish to test whether adding these 4 predictors to the initial model results in an increase of at least 1% in the variance explained by the model. Considering a significance level (alpha) of 5% and a power of 90%, the required sample size is 1530. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients of both sexes who have undergone total knee replacement (unilateral or bilateral), unicompartmental and total knee replacement (unilateral or bilateral), and total shoulder replacement.
Key inclusion criteria (1 listed)
- Adult patients in ASA Class I-II-III undergoing prosthetic surgery, as a first-time implant
Key exclusion criteria (2 listed)
- Patients who did not receive tranexamic acid prophylaxis (pre-operative and post- operative doses) and are therefore not comparable with the vast majority of cases.
- Reintervention, as bleeding depends on a variable that is not constant, namely the initial implant
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
The primary objective is to assess the extent and variability of blood loss in comparison with the literature and in relation to the various intraoperative techniques used. The assessment will be carried out by analysing the parameters (haemoglobin - hae
Time frame: 6 months
A likelihood ratio test will also be performed to assess whether the full model performs better in terms of explained variance compared to the initial model including sex, age, ASAC risk class, and antiplatelet or anticoagulant therapy. Furthermore, all model coefficients will be evaluated individually and together with their 95% confidence intervals to assess the presence of statistically differences between the various surgical techniques.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: Yes. Dr. Claudio Legnani is an Orthopaedic physician well involv ed in this field, and I want to take part with another expert
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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.
Giorgio Oriani, P.I. principal investigator
IRCCS Laleazzi Sant Ambrogio Site San Siro Institute
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 Orthopaedic Surgery, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio 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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 21 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giorgio Oriani, Principal Investigator (+39335225452, gorian@alice.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective is to assess the extent and variability of blood loss in comparison with the literature and in relation to the various intraoperative techniques used. The assessment will be carried out by analysing the parameters (haemoglobin - hae (time frame: 6 months). 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 21 Sep 2026.