Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05467319
Other study ID # FORGEII
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date September 30, 2022
Est. completion date December 2023

Study information

Verified date July 2022
Source Alberta Health Services, Calgary
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Iron deficiency has been reported in up to 35% of patients with a gynecologic malignancy. These patients often require surgical intervention to determine the stage and to treat their illness. Blood transfusions occur in approximately 14% of these surgeries and carry immediate and long-term risks, including surgical site infection, cancer recurrence, and increased surgical length of stay. Intravenous iron formulations have the potential to rapidly correct anemia in patients with gynecologic malignancy and potentially decrease blood transfusion and complications following surgery. This prospective, randomized, placebo-controlled, double blind study aims to assess the effectiveness of preoperative ferric derisomaltose/iron isomaltoside compared to placebo in correcting preoperative hemoglobin in patients undergoing surgery for gynecologic malignancy. The primary outcome is to assess the effectiveness of this formulation on pre-operative hemoglobin, and the feasibility of a larger, outcomes based, study in the future. Exploratory outcomes are to assess the effect of preoperative intravenous iron on surgical length of stay, complications, and patient-reported quality of life.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 82
Est. completion date December 2023
Est. primary completion date September 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. At least 18 years of age and signed written informed consent 2. Patients undergoing elective major surgery on the gynecologic oncology service with the following criteria will be considered for inclusion: 1. The indication for the operation may be for suspected or proven gynecologic malignancy. 2. Major surgery is defined as an operation of a duration of 1 hour or greater, with an Aletti complexity score of at least 1[19]. 3. The expected time from recruitment to surgery is at least 28 days. 3. Screening haemoglobin less than 120g/L and transferrin saturation (TSAT) <20% 4. Randomization and administration of study infusion a minimum of 21 days and maximum 90 days before planned operation. 5. Negative pregnancy test for women of childbearing potential (within last 7 days), and agree to use effective form of contraception until 6 weeks post treatment (if applicable) 6. Laboratory data used for determination of eligibility at the baseline visit must not be older than 4 weeks. Exclusion Criteria: 1. Known history of acquired iron overload, or family history of haemochromatosis or thalassemia, or TSAT >50% 2. Known alternative cause for anemia (e.g. B12 or folate deficiency, or haemoglobinopathy) 3. Known hypersensitivity to FDI or its excipients 4. Temperature >38 C or patient on non-prophylactic antibiotics 5. Known chronic liver disease or active hepatitis 6. Received erythropoietin or IV iron therapy in previous 12 weeks 7. If LFT's are ordered, either clinically indicated or for chemotherapy, and screening alanine transaminase (ALT) or aspartate transaminase (AST) is above three times the upper limit of normal (ULN) range 8. Immunosuppressive therapy (for solid organ transplant), or renal dialysis (current, or planned within next 12 months) 9. Unfit for elective surgery 10. Pregnancy or lactation 11. Unable to fully comprehend and/or perform study procedures 12. Cervical cancer with a clinical stage of 2A or greater.

Study Design


Intervention

Drug:
Ferric Derisomaltose Injection
1000mg of ferric derisomaltose in 100mL of normal saline by intravenous infusion
Normal saline
100 mL of 0.9% normal saline (w/v) by intravenous infusion

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Alberta Health Services, Calgary Pharmacosmos A/S

Outcome

Type Measure Description Time frame Safety issue
Primary Preoperative hemoglobin level Hemoglobin measured, in g/L, following intervention prior to planned gynecologic surgery. 0 to 3 days prior to planned surgical intervention
See also
  Status Clinical Trial Phase
Recruiting NCT05583916 - Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung Surgery N/A
Completed NCT04448041 - CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
Completed NCT03213314 - HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies N/A
Enrolling by invitation NCT05534490 - Surgery and Functionality in Older Adults N/A
Recruiting NCT04792983 - Cognition and the Immunology of Postoperative Outcomes
Terminated NCT04612491 - Pre-operative Consultation on Patient Anxiety and First-time Mohs Micrographic Surgery
Recruiting NCT06397287 - PROM Project Urology
Recruiting NCT04444544 - Quality of Life and High-Risk Abdominal Cancer Surgery
Completed NCT04204785 - Noise in the OR at Induction: Patient and Anesthesiologists Perceptions N/A
Completed NCT03432429 - Real Time Tissue Characterisation Using Mass Spectrometry REI-EXCISE iKnife Study
Completed NCT04176822 - Designing Animated Movie for Preoperative Period N/A
Recruiting NCT05370404 - Prescribing vs. Recommending Over-The-Counter (PROTECT) Analgesics for Patients With Postoperative Pain: N/A
Recruiting NCT04602429 - Children's Acute Surgical Abdomen Programme
Completed NCT03124901 - Accuracy of Noninvasive Pulse Oximeter Measurement of Hemoglobin for Rainbow DCI Sensor N/A
Completed NCT04595695 - The Effect of Clear Masks in Improving Patient Relationships N/A
Recruiting NCT06103136 - Maestro 1.0 Post-Market Registry
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Completed NCT04059328 - Novel Surgical Checklists for Gynecologic Laparoscopy in Haiti
Recruiting NCT03697278 - Monitoring Postoperative Patient-controlled Analgesia (PCA) N/A
Completed NCT03355547 - Observation of Atelectasis Using Lung Ultrasonography in Children Undergoing General Anesthesia: the Cohort Study for Evaluation of the Relationship Between the Incidence and Severity of Upper Respiratory Tract Infection and the Magnitude of Anesthesia-induced Atelectasis