Perioperative Management in Gynaecological Carcinoma Surgery

• Status: Recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study is to determine the effect of perioperative treatment with intravenous iron and tranexamic acid on the reduction of intraoperative and postoperative RBC transfusions in gynaecological carcinoma patients undergoing abdominal surgery.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Basel, Switzerland
• Treatments: Ferric Compounds; Tranexamic Acid

Criteria

Inclusion Criteria:

• informed consent as documented by signature

• women with gynaecological carcinoma surgery with hemoglobin level between 90-120 g/I and serum ferritin < 100 µg/I (or ferritin index < 3.19) at recruitment

• pregnancy test negative in women younger than 50 years

Exclusion Criteria:

• known hypersensitivity or allergy to ferric carboxymaltose or tranexamic acid

• history or present laboratory signs of bleeding disorders, coagulopathy or thromboembolic events

• history of myocardial infarction within the last year, present unstable angina or severe coronary disease

• increased plasma creatinine levels above 250 µmol/I

• inability to follow the procedures of the study (language problems, severe psychiatric or mental disorders)

• iron overload

• current administration of intravenous iron or previous intravenous iron therapy or blood transfusion within three months

• date of scheduled surgery is outside 28 days after the date of recruitment

• other clinically significant concomitant disease states (e.g., hepatic dysfunction, cardiovascular disease, etc.)

• participation in another study with investigational drug within the 30 days

• enrolment of the investigator, his/her family members, employees and other dependent persons.