Gynaecological Carcinoma Clinical Trial
Official title:
Perioperative Management With Ferric Carboxymaltose and Tranexamic Acid to Reduce Transfusion Rate in Gynaecological Carcinoma Surgery: a Single-blind, Mono-centre, Randomized Trial
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.
| Status | Recruiting |
| Enrollment | 126 |
| Est. completion date | December 31, 2026 |
| Est. primary completion date | December 31, 2026 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Department of Obstetrics and Gynaecology, University Hospital Basel | Basel |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Basel, Switzerland |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | number of all perioperative (intraoperative and postoperative) administered RBC transfusions | number of all perioperative (intraoperative and postoperative) administered RBC transfusions (the absolute rate of RBC transfusions) | day of surgery until follow up visit 5 (up to 28 days) | |
| Secondary | change in hemoglobin level | change in hemoglobin level (g/dl) | day of surgery until follow up visit 5 (up to 28 days) | |
| Secondary | rate of transfused women with gynaecological carcinoma during and/or after surgery | rate of transfused women with gynaecological carcinoma during and/or after surgery | day of surgery until follow up visit 5 (up to 28 days) | |
| Secondary | blood loss measured during surgery (ml) | blood loss measured during surgery (ml) | day of surgery | |
| Secondary | rate of other blood product transfusions | rate of other blood product transfusions (fresh frozen plasma, autologous whole blood) | day of surgery until follow up visit 5 (up to 28 days) | |
| Secondary | requirement of additional local or systematic haemostatic therapy (descriptive) | requirement of additional local or systematic haemostatic therapy (descriptive) | day of surgery until follow up visit 5 (up to 28 days) | |
| Secondary | duration of surgery (minutes) | duration of surgery (minutes) | day of surgery | |
| Secondary | duration of hospitalisation (days) | duration of hospitalisation (days) | from admission to discharge date (up to 56 days) | |
| Secondary | number of postoperative complications | number of postoperative complications: abdominal pain, haemorrhage, reoperation owing to bleeding, wound infection, pulmonary complications, postoperative renal dysfunction, systemic sepsis | day of surgery until follow up visit 5 (up to 28 days) | |
| Secondary | postoperative mortality | postoperative mortality | day of surgery until follow up visit 5 (up to 28 days) |