1. number of all perioperative (intraoperative and postoperative) administered RBC transfusions (Time Frame - 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 outcome:
1. change in hemoglobin level (Time Frame - day of surgery until follow up visit 5 (up to 28 days)): change in hemoglobin level (g/dl)
2. 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)): rate of transfused women with gynaecological carcinoma during and/or after surgery
3. blood loss measured during surgery (ml) (Time Frame - day of surgery): blood loss measured during surgery (ml)
4. rate of other blood product transfusions (Time Frame - day of surgery until follow up visit 5 (up to 28 days)): rate of other blood product transfusions (fresh frozen plasma, autologous whole blood)
5. requirement of additional local or systematic haemostatic therapy (descriptive) (Time Frame - day of surgery until follow up visit 5 (up to 28 days)): requirement of additional local or systematic haemostatic therapy (descriptive)
6. duration of surgery (minutes) (Time Frame - day of surgery): duration of surgery (minutes)
7. duration of hospitalisation (days) (Time Frame - from admission to discharge date (up to 56 days)): duration of hospitalisation (days)
8. number of postoperative complications (Time Frame - 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
9. postoperative mortality (Time Frame - day of surgery until follow up visit 5 (up to 28 days)): postoperative mortality
Experimental: ferric carboxymaltose ferric carboxymaltose 20 mg/kg (with a maximum dose of 1000 mg ferric carboxymaltose in a single Infusion) (Ferinject® 1000 mg/20 ml) will be administered between day -27 and day -7.
Experimental: tranexamic 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
Experimental: ferric carboxymaltose and tranexamic acid ferric carboxymaltose (Ferinject® 1000 mg/20 ml) 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 will be administered.
No Intervention: no treatment accordingly "current standard of care" no treatment accordingly "current standard of care" will be given
ferric 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.
tranexamic 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.
ferric 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.
Quelle: ClinicalTrials.gov
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"Perioperative Management in Gynaecological Carcinoma Surgery"
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