Gynaecological Carcinoma
Conditions
Keywords
ferric carboxymaltose, tranexamic acid, RBC transfusion
Brief 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.
Detailed 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.
Interventions
DRUGferric carboxymaltose
Ferric carboxymaltose 20 mg/kg (with a maximum dose of 1000 mg ferric carboxymaltose in a single Infusion) (Ferinject® 1000 mg/20ml, Vifor (International) AG, St. Gallen, Switzerland) will be diluted in 250 ml of 0.9% m/V sodium chloride solution and administered over 15 minutes intravenously between day -27 and day -7. The colour of ferric carboxymaltose is dark brown. A single Ferinject administration should not exceed 20 mg iron/kg body weight.
DRUGtranexamic acid
Tranexamic acid 10mg/kg (Tranexam OrPha 1000 mg/10 ml, OrPha Swiss GmbH, Küsnacht, Switzerland) will be administered 15 -30 minutes prior to surgery followed by infusion of tranexamic acid through syringe pump (1 mg/kg/h) till 4 h postoperatively. The colour of the medicament is transparent.
DRUGferric carboxymaltose and tranexamic acid
Ferric carboxymaltose (Ferinject® 1000 mg/20 ml) will be administered between day -27 and day -7 and tranexamic acid (Tranexam OrPha 1000 mg/10 ml) 15-30 minutes prior to surgery followed by infusion of tranexamic acid through syringe pump (1 mg/kg/h) till 4 h postoperatively.
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of all perioperative (intraoperative and postoperative) administered RBC transfusions | day of surgery until follow up visit 5 (up to 28 days) | number of all perioperative (intraoperative and postoperative) administered RBC transfusions (the absolute rate of RBC transfusions) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| rate of transfused women with gynaecological carcinoma during and/or after surgery | day of surgery until follow up visit 5 (up to 28 days) | rate of transfused women with gynaecological carcinoma during and/or after surgery |
| blood loss measured during surgery (ml) | day of surgery | blood loss measured during surgery (ml) |
| rate of other blood product transfusions | day of surgery until follow up visit 5 (up to 28 days) | rate of other blood product transfusions (fresh frozen plasma, autologous whole blood) |
| requirement of additional local or systematic haemostatic therapy (descriptive) | day of surgery until follow up visit 5 (up to 28 days) | requirement of additional local or systematic haemostatic therapy (descriptive) |
| change in hemoglobin level | day of surgery until follow up visit 5 (up to 28 days) | change in hemoglobin level (g/dl) |
| duration of hospitalisation (days) | from admission to discharge date (up to 56 days) | duration of hospitalisation (days) |
| number of postoperative complications | day of surgery until follow up visit 5 (up to 28 days) | number of postoperative complications: abdominal pain, haemorrhage, reoperation owing to bleeding, wound infection, pulmonary complications, postoperative renal dysfunction, systemic sepsis |
| postoperative mortality | day of surgery until follow up visit 5 (up to 28 days) | postoperative mortality |
| duration of surgery (minutes) | day of surgery | duration of surgery (minutes) |
Countries
Switzerland
Outcome results
None listed