Perioperative Management in Gynaecological Carcinoma Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Gynaecological Carcinoma
• Intervention / Treatment: Drug: ferric carboxymaltose; Drug: tranexamic acid; Drug: ferric carboxymaltose and tranexamic acid

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 Type: Interventional
• Enrollment (Estimated): 126
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Gabriela Amstad Bencaiova, Dr. med.; Phone Number: +41 61 556 59 22; Email: gabriela.amstad@usb.ch
• Study Contact Backup: Name: Viola Heinzelmann, Prof. Dr. med.; Email: viola.heinzelmann@usb.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Recruiting
    • Department of Obstetrics and Gynaecology, University Hospital Basel
    • Contact: Gabriela Amstad Bencaiova, Dr. med.; Phone Number: +41 61 556 59 22; Email: gabriela.amstad@usb.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: 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.
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	Drug: 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.
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.	Drug: 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.
No Intervention: no treatment accordingly "current standard of care"; no treatment accordingly "current standard of care" will be given

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in hemoglobin level	change in hemoglobin level (g/dl)	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	day of surgery until follow up visit 5 (up to 28 days)
blood loss measured during surgery (ml)	blood loss measured during surgery (ml)	day of surgery
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)
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)
duration of surgery (minutes)	duration of surgery (minutes)	day of surgery
duration of hospitalisation (days)	duration of hospitalisation (days)	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	day of surgery until follow up visit 5 (up to 28 days)
postoperative mortality	postoperative mortality	day of surgery until follow up visit 5 (up to 28 days)

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Gabriela Amstad Bencaiova, Dr. med., Department of Obstetrics and Gynaecology, University Hospital Basel

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 4, 2020
• First Submitted That Met QC Criteria: November 10, 2020
• First Posted (Actual): November 12, 2020

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: tranexamic acid; ferric carboxymaltose; RBC transfusion
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Hematinics; Tranexamic Acid; Ferric Compounds
• Other Study ID Numbers: 2020-01194; sp20Amstad

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data generated by our research will be available as soon as possible, wherever legally and ethically possible. The data will be made available upon reasonable request. The deidentified participant data from this study and related documents (study protocol, statistical analysis plan, patient consent form) will be made available upon request. Researchers may request data to repeat the analyses or use the data for secondary analyses (e. g., systematic review and meta-analysis). Changes to this plan will be noted in the Data Availability Statement and updated in the registry record (to comply with ICMJE recommendations).
• IPD Sharing Time Frame: The data will become available upon reasonable request for one month.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No