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NCT Number: NCT07500350

The Influence of Perioperative Strategies on the Extent of 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.

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Key information

Conditions

Orthopaedic Surgery

Sex eligibility

All sexes

Study type

Observational

Primary location

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Milan, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Georges Ghanem, Chief of Anesthetic Dept

CONTACT

[email protected]

+39-2-48785206

Giorgio Oriani, Principal Investigator

CONTACT

[email protected]

+39335225452

Sponsors and collaborators

Lead sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Other

Registry information

Official study title

Influence of Perioperative Strategies on the Extent of Total Blood Loss in Orthopaedic Prosthetic Surgery

Acronym: IPECO

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2028
First posted: Mar 30, 2026
Registry last updated: Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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