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Perioperative Management With Ferric Carboxymaltose and Tranexamic Acid to Reduce Transfusion Rate in Gynaecological Carcinoma Surgery

NCT04625530Phase 3

Key facts

Status: Withdrawn
Start: Aug 2021
Primary completion: Dec 2026
Countries: 1
Sponsor: University Hospital Basel
Modality: Small Molecules

Drugs: ferric carboxymaltosetranexamic acid
Conditions: gynecologic carcinoma

Overview

Phase 3, randomised, single-blind trial of ferric carboxymaltose and tranexamic acid in gynecologic carcinoma (4 arms), sponsored by University Hospital Basel. Primary endpoint: Number of all perioperative (intraoperative and postoperative) administered RBC transfusions up to 28 days. Planned start Aug 2021; status: withdrawn.

Design

4 arms

Study design: RandomizedSingle-blind

ferric carboxymaltose
Preoperative ferric carboxymaltose only.
tranexamic acid
Perioperative tranexamic acid only.
ferric carboxymaltose and tranexamic acid
Combination of preoperative ferric carboxymaltose and perioperative tranexamic acid.
no treatment accordingly "current standard of care"
Standard of care without study interventions.

Who it enrols

Women undergoing gynaecological carcinoma surgery with mild anemia (Hb 90-120 g/l) and iron deficiency, excluding those with bleeding disorders, recent myocardial infarction, or recent intravenous iron/blood transfusions.

Endpoints

Primary

Number of all perioperative (intraoperative and postoperative) administered RBC transfusionsup to 28 days

Secondary

Change in hemoglobin levelup to 28 days
Rate of transfused women with gynaecological carcinoma during and/or after surgeryup to 28 days
Blood loss measured during surgeryDay 0
Rate of other blood product transfusionsup to 28 days
Requirement of additional local or systematic haemostatic therapyup to 28 days
Duration of surgeryDay 0
Duration of hospitalisationup to 56 days
Number of postoperative complicationsup to 28 days

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