Perioperative Management in Gynaecological Carcinoma Surgery

University Hospital Basel

Status and phase: Withdrawn; Phase 3

Conditions: Gynaecological Carcinoma

Treatments: Drug: ferric carboxymaltose and tranexamic acid; Drug: ferric carboxymaltose; Drug: tranexamic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT04625530

2020-01194 sp20Amstad;

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 4 patient groups

ferric carboxymaltose

Experimental group

Description:

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.

Treatment:

Drug: ferric carboxymaltose

tranexamic acid

Experimental group

Description:

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

Treatment:

Drug: tranexamic acid

ferric carboxymaltose and tranexamic acid

Experimental group

Description:

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.

Treatment:

Drug: ferric carboxymaltose and tranexamic acid

no treatment accordingly "current standard of care"

No Intervention group

Description:

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