Perioperative Management in Gynaecological Carcinoma Surgery

NCT ID: NCT04625530

Last Updated: 2025-04-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2026-12-31

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.

Conditions

Gynaecological Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

ferric carboxymaltose

Intervention Type: DRUG

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

Group Type: EXPERIMENTAL

tranexamic acid

Intervention Type: DRUG

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) 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.

Group Type: EXPERIMENTAL

ferric carboxymaltose and tranexamic acid

Intervention Type: DRUG

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 treatment accordingly "current standard of care"

no treatment accordingly "current standard of care" will be given

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gabriela Amstad Bencaiova, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Department of Obstetrics and Gynaecology, University Hospital Basel

Locations

Department of Obstetrics and Gynaecology, University Hospital Basel

Basel, , Switzerland

Countries

Switzerland

Other Identifiers

2020-01194; sp20Amstad

Identifier Type: -

Identifier Source: org_study_id