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

Study acronym: IPECO
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Notable Recruitment opened Show 4 more changesShow less
    • Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio to I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
    • Site details revised
    • Eligibility criteria expanded, about 2 words
    • Study description expanded, about 3 words
  2. Notable Start date: Apr 8, 2026 to Jul 8, 2026
    • Eligibility criteria expanded, about 1 word
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07500350
Lead Sponsor I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Conditions
(from sponsor)
Orthopaedic Surgery
Enrollment 1,683 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov