Application of Patient Blood Management in the Oncology Patient Affected by Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Evaluation of the percentage of transfusions in patients with breast cancer undergoing surgery after preventive treatment with haematinics.
Detailed description
Preoperative anemia treatment is fundamental in Patient Blood Management (PBM) programs, a multidisciplinary and multimodal strategy that improves clinical outcomes based on the patient's blood resource, promoting strategies to optimize hematopoiesis in candidates for elective surgery, in order to significantly reduce the use of blood products, addressing all modifiable transfusion risk factors before it is even necessary to consider the use of transfusion therapy itself. Treatment with intravenous iron reduces the transfusion risk and consequently the adverse events related to the transfusion itself.
Nothing is specified in this regard for cancer patients; very often these patients come to surgery presenting an anaemic state that often requires correction with red blood cell transfusion. The aim of this clinical study is to prevent the number of perioperative transfusions in patients with breast cancer who have undergone or not undergone neoadjuvant chemotherapy and with Hb values lower than or equal to 11 g/dl, who are candidates for destructive and/or reconstructive surgery.
Primary outcome measures
- Number of transfusions [Time frame: 18 months]
Eligibility criteria
Inclusion criteria
- age > 18 years;
- patients diagnosed with histologically confirmed breast cancer and whether or not they have undergone neoadjuvant chemotherapy;
- patients who are candidates for destructive and reconstructive breast surgery or not;
- Hb values less than or equal to 11 g/dL and/or transferrin saturation less than or equal to 20%;
- written informed consent.
Exclusion criteria
- patients with known allergies to ferric carboxymaltose or its excipients;
- ferritin values greater than 500 ng/ml;
- patients unable to sign consent and comply with procedures.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- "Regina Elena" National Cancer Institute — Rome
Identifiers
NCT: NCT06883201 · RS1796/22