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Clinical trial

Perioperative Management With Ferric Carboxymaltose and Tranexamic Acid to Reduce Transfusion Rate in Gynaecological Carcinoma Surgery: a Single-blind, Mono-centre, Randomized Trial

ID
Name
2020-01194; sp20Amstad
Description
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.
Trial arms
Trial start
2021-08-01
Estimated PCD
2026-12-31
Trial end
2026-12-31
Status
Recruiting
Phase
Early phase I
Treatment
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.
Arms:
ferric carboxymaltose
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.
Arms:
tranexamic acid
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.
Arms:
ferric carboxymaltose and tranexamic acid
Size
126
Primary endpoint
number of all perioperative (intraoperative and postoperative) administered RBC transfusions
day of surgery until follow up visit 5 (up to 28 days)
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'The study will be blinded to participants and statistician conducting the data analysis. The physicians and nurses who will perform this infusion will not be blinded.', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 126, 'type': 'ESTIMATED'}}
Updated at
2024-03-01

1 organization

3 products

1 indication

Organization
University Hospital Basel
Product
Ferric Carboxymaltose
Indication
Gynecological Carcinoma
Product
Tranexamic acid
Product
Ferric Carboxymaltose + Tranexamic Acid