Managing blood health before prosthetic surgery
Patient Blood Management in the Approach to Prosthetic Surgery in Orthopedic
NA · I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · NCT05806437
This study is testing different ways to improve blood health in people with anemia or low iron before they have prosthetic surgery to see if it can reduce the need for blood transfusions during the operation.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 142 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio (other) |
| Locations | 1 site (Milan) |
| Trial ID | NCT05806437 on ClinicalTrials.gov |
What this trial studies
This study focuses on optimizing patient blood management for individuals undergoing prosthetic surgery, particularly those with anemia or iron deficiency. It aims to analyze various diagnostic factors and laboratory parameters to determine the best preoperative preparation strategies. The effectiveness of treatments such as ferric carboxymaltose and chelated iron will be evaluated in relation to the need for blood transfusions during surgery.
Who should consider this trial
Good fit: Ideal candidates are patients over 40 years old, scheduled for prosthetic surgery, with specific anemia criteria.
Not a fit: Patients with Mediterranean anemia or coagulation disorders will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the need for blood transfusions in patients undergoing prosthetic surgery.
How similar studies have performed: Other studies have shown promising results in patient blood management approaches, indicating potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Candidates for prosthetic surgery * Patients of both sexes over 40 years of age * Hemoglobin values \<12 g% for females and 13 g% for males * % transferrin saturation \< 10% * Willingness and ability to provide informed consent. Exclusion Criteria: * Patients with Mediterranean anemia * Patients with coagulation disorders * Patients who do not sign the consent form * Pregnant or breastfeeding women (self-declaration) * Minor aged
Where this trial is running
Milan
- IRCCS Istituto Ortopedico Galeazzi-Istituto Clinico San Siro — Milan, Italy (RECRUITING)
Study contacts
- Study coordinator: Elena Cittera
- Email: elena.cittera@grupposandonato.it
- Phone: 0283502224
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anemia, Iron Deficiency