The Influence of Perioperative Strategies on the Extent of in Orthopaedic Prosthetic Surgery (IPECO)

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Orthopaedic Surgery

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

  4. 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 Type: Observational
• Enrollment (Estimated): 1683

Contacts and Locations

• Study Contact: Name: Giorgio Oriani, Principal Investigator; Phone Number: +39335225452; Email: gorian@alice.it
• Study Contact Backup: Name: Georges Ghanem, Chief of Anesthetic Dept; Phone Number: +39-2-48785206; Email: georges.ghanem@grupposandonato.it

Study Locations

• Italy
  • Milan
    • Milan, Milan, Italy
      • I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion criteria Adult patients in ASA Class I-II-III undergoing prosthetic surgery, as a first-time implant

Exclusion criteria 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.

Reoperation, as bleeding depends on a variable that is not constant, namely the initial implant

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Collaborators and Investigators

• Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
• Investigators: Principal Investigator: Giorgio Oriani, P.I., IRCCS Laleazzi Sant Ambrogio Site San Siro Institute

Study record dates

Study Major Dates

• Study Start (Estimated): April 8, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: March 24, 2026
• First Submitted That Met QC Criteria: March 24, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: IPECO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Dr. Claudio Legnani is an Orthopaedic physician well involv ed in this field, and I want to take part with another expert
• IPD Sharing Time Frame: March 2026 to March 2028
• IPD Sharing Access Criteria: collecting parameters and analyzing data. Contact Statystical group with me
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No