Perioperative Management in Gynaecological Carcinoma Surgery

Phase 3

Withdrawn

• Conditions: Gynaecological Carcinoma
• Interventions: Drug: ferric carboxymaltose and tranexamic acid; Drug: ferric carboxymaltose; Drug: tranexamic acid

• Registration Number: NCT04625530
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Study Timeline

• Study First Submitted: 2020-11-04
• Study First Submitted QC: 2020-11-10
• Study First Posted: 2020-11-12
• Study Start: 2021-08-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-14
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: 126

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ferric carboxymaltose and tranexamic acid	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.
ferric carboxymaltose	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.
tranexamic acid	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
change in hemoglobin level	day of surgery until follow up visit 5 (up to 28 days)	change in hemoglobin level (g/dl)
blood loss measured during surgery (ml)	day of surgery	blood loss measured during surgery (ml)
duration of hospitalisation (days)	from admission to discharge date (up to 56 days)	duration of hospitalisation (days)
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
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)
duration of surgery (minutes)	day of surgery	duration of surgery (minutes)
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

Trial Locations

Locations (1)

Department of Obstetrics and Gynaecology, University Hospital Basel; 🇨🇭 Basel, Switzerland