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Iron Sucrose for Anemia
Phase 1 & 2
Waitlist Available
Led By Lisa Barroilhet, MD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 72 hours of surgery, up to 5 weeks on study
Awards & highlights
Study Summary
This trial will test whether IV infusions of iron sucrose can improve iron stores in ovarian cancer patients before surgery, and reduce the need for transfusions of packed red blood cells during surgery.
Eligible Conditions
- Anemia
- Ovarian Cancer
- Iron-Deficiency Anemia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 72 hours of surgery, up to 5 weeks on study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 72 hours of surgery, up to 5 weeks on study
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of Peri-operative Blood Transfusion
Secondary outcome measures
Incidence of Treatment Emergent Adverse Events (AEs)
Rate of Iron Deficiency Anemia
Rate of Resolution of Iron Deficiency Anemia After Intervention
Side effects data
From 2017 Phase 4 trial • 296 Patients • NCT0122761638%
Gastrointestinal disorders
33%
Infections and infestations
31%
Injury, poisoning and procedural complications
29%
General disorders and administration site conditions
21%
Respiratory, thoracic and mediastinal disorders
20%
Musculoskeletal and connective tissue disorders
19%
Vascular disorders
18%
Nervous system disorders
16%
Metabolism and nutrition disorders
15%
Cardiac disorders
11%
Nausea
11%
Diarrhoea
10%
Skin and subcutaneous tissue disorders
9%
Hypotension
9%
Psychiatric disorders
8%
Vomiting
8%
Muscle spasms
8%
Pyrexia
7%
Arteriovenous fistula site complication
7%
Blood and lymphatic system disorders
7%
Upper respiratory tract infection
7%
Fluid overload
7%
Pain in extremity
7%
Hypertension
6%
Urinary tract infection
6%
Hyperkalaemia
6%
Investigations
6%
Pruritus
6%
Abdominal pain
6%
Cough
6%
Dyspnoea
6%
Pneumonia
5%
Sepsis
5%
Non-cardiac chest pain
5%
Dizziness
4%
Arteriovenous fistula thrombosis
4%
Fall
4%
Acute respiratory failure
4%
Arthralgia
4%
Headache
4%
Anaemia
3%
Mental status changes
3%
Pulmonary oedema
3%
Cardiac failure congestive
3%
Cellulitis
2%
Angina pectoris
2%
Gastrointestinal haemorrhage
2%
Hip fracture
2%
Cardiac arrest
2%
Acute myocardial infarction
2%
Pleural effusion
2%
Cardio-respiratory arrest
1%
Hypoglycaemia
1%
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
1%
Immune system disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ferumoxytol
Iron Sucrose
Trial Design
1Treatment groups
Experimental Treatment
Group I: IV Iron SucroseExperimental Treatment1 Intervention
Four intravenous iron sucrose infusions prior to debulking surgery administered as four 200mg infusions, given no less than 7 days apart over a 30 day +/- 7 day period
Find a Location
Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,183 Previous Clinical Trials
3,167,578 Total Patients Enrolled
Lisa Barroilhet, MDPrincipal InvestigatorUniversity of Wisconsin, Madison
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still positions open for participants in this trial?
"That's right, the listing on clinicaltrials.gov currently says that this study is recruiting patients. This particular trial was first advertised on 7/29/2019, and the most recent update was on 10/5/2022. They are hoping to find 21 volunteers for the 1 site location."
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