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NCT07500350
The Influence of Perioperative Strategies on the Extent of in Orthopaedic Prosthetic Surgery
Conditions: Orthopaedic Surgery
Sex: All
Healthy volunteers: No
Enrollment: 1683
Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Location: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio Milan Milan
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07500350). StuddyBuddy aggregates publicly available trial information.