Clinical trial · Interventional
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
NCT04625530CI-TRIAL-00088531withdrawnPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Issue with grant transfer upon sponsor relocation
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynaecological Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ferric carboxymaltose | Drug | — | UNRESOLVED |
| ferric carboxymaltose and tranexamic acid | Drug | — | UNRESOLVED |
| tranexamic acid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- ferric carboxymaltose
- 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.
- interventionNames
- Drug: ferric carboxymaltose
- type
- EXPERIMENTAL
- label
- tranexamic acid
- 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
- interventionNames
- Drug: tranexamic acid
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.