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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
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.
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.
Department of Obstetrics and Gynaecology, University Hospital Basel
Basel, Switzerland
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)
Time frame: day of surgery until follow up visit 5 (up to 28 days)
change in hemoglobin level
change in hemoglobin level (g/dl)
Time frame: day of surgery until follow up visit 5 (up to 28 days)
rate of transfused women with gynaecological carcinoma during and/or after surgery
rate of transfused women with gynaecological carcinoma during and/or after surgery
Time frame: day of surgery until follow up visit 5 (up to 28 days)
blood loss measured during surgery (ml)
blood loss measured during surgery (ml)
Time frame: day of surgery
rate of other blood product transfusions
rate of other blood product transfusions (fresh frozen plasma, autologous whole blood)
Time frame: day of surgery until follow up visit 5 (up to 28 days)
requirement of additional local or systematic haemostatic therapy (descriptive)
requirement of additional local or systematic haemostatic therapy (descriptive)
Time frame: day of surgery until follow up visit 5 (up to 28 days)
duration of surgery (minutes)
duration of surgery (minutes)
Time frame: day of surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
duration of hospitalisation (days)
duration of hospitalisation (days)
Time frame: from admission to discharge date (up to 56 days)
number of postoperative complications
number of postoperative complications: abdominal pain, haemorrhage, reoperation owing to bleeding, wound infection, pulmonary complications, postoperative renal dysfunction, systemic sepsis
Time frame: day of surgery until follow up visit 5 (up to 28 days)
postoperative mortality
postoperative mortality
Time frame: day of surgery until follow up visit 5 (up to 28 days)