Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery)
Recruiting
Phase 3
Interventional Study
Gynecologic Cancer
Anemia
Iron-deficiency
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 82 (estimated)
- Sponsor
- AHS Cancer Control Alberta · Other
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About This Trial
Iron deficiency has been reported in approximately 35% of patients with a gynecologic malignancy. Blood transfusions are known to be immunosuppressive and carry immediate and long-term risks. Pre-operative blood transfusion in gynecologic oncology patients is associated with higher rates of surgical site infection, length of stay, composite morbidity, cancer recurrence, and mortality. Pre-operativ…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Signed written informed consent prior to initiation of any study specific activities/procedures.
2. Age ≥ 18 years old.
3. Patients undergoing elective major surgery on the gynecologic oncology service with the following criteria will be considered for inclusion:
1. The i…
Contacts