Issue with grant transfer upon sponsor relocation

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.

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.

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.

The data generated by our research will be available as soon as possible, wherever legally and ethically possible. The data will be made available upon reasonable request. The deidentified participant data from this study and related documents (study protocol, statistical analysis plan, patient consent form) will be made available upon request. Researchers may request data to repeat the analyses or use the data for secondary analyses (e. g., systematic review and meta-analysis). Changes to this plan will be noted in the Data Availability Statement and updated in the registry record (to comply with ICMJE recommendations).

The data will become available upon reasonable request for one month.

The study will be blinded to participants and statistician conducting the data analysis. The physicians and nurses who will perform this infusion will not be blinded.