Skip to content

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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07500350
Acronym
IPECO
Enrollment
1683
Registered
2026-03-30
Start date
2026-07-08
Completion date
2028-03-01
Last updated
2026-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthopaedic Surgery

Brief 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 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 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.

Interventions

None listed

Sponsors

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

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 - hae6 monthsA 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.

Countries

Italy

Contacts

CONTACTGiorgio Oriani, Principal Investigator
gorian@alice.it+39335225452
CONTACTGeorges Ghanem, Chief of Anesthetic Dept
georges.ghanem@grupposandonato.it+39-2-48785206
PRINCIPAL_INVESTIGATORGiorgio Oriani, P.I.

IRCCS Laleazzi Sant Ambrogio Site San Siro Institute

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 25, 2026