Surgery Clinical Trial
— FORGEOfficial title:
Feasibility and Efficacy of Intravenous Ferric Derisomaltose to Correct Pre-operative Iron-deficiency Anemia in Patients Undergoing Gynecologic Oncology Surgery: a Pilot Randomized Double Blinded Parallel Group Placebo-controlled Study
Verified date | July 2022 |
Source | Alberta Health Services, Calgary |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Alberta Health Services, Calgary | Pharmacosmos A/S |
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 |
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
|