Perioperative Management in Gynaecological Carcinoma Surgery

  • STATUS
    Recruiting
  • End date
    Aug 1, 2024
  • participants needed
    126
  • sponsor
    University Hospital, Basel, Switzerland
Updated on 11 March 2022

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.

Description

Radical abdominal surgery often leads to intraoperative bleeding frequently exceeding 1000 ml and approximately 50% of women undergoing this surgery require blood transfusion. Perioperative blood transfusions have been shown to increase of length of stay, surgical complications, postoperative morbidity and mortality. There are a few data on the reduction in red blood cell count (RBC) transfusions using perioperative management with intravenous iron and tranexamic acid in women with gynaecological carcinoma surgery. 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.

Details
Condition Gynaecological Carcinoma
Treatment Ferric carboxymaltose, Tranexamic Acid, ferric carboxymaltose and tranexamic acid
Clinical Study IdentifierNCT04625530
SponsorUniversity Hospital, Basel, Switzerland
Last Modified on11 March 2022

Eligibility

Yes No Not Sure

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
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