Perioperative Management in Gynaecological Carcinoma Surgery

NCT04625530 | Withdrawn Phase 3

• 1 other identifier: 2020-01194; sp20Amstad
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynaecological Carcinoma

Keywords

ferric carboxymaltose; tranexamic acid; RBC transfusion

Outcome Measures

Primary Outcomes (1)

• number of all perioperative (intraoperative and postoperative) administered RBC transfusions

  number of all perioperative (intraoperative and postoperative) administered RBC transfusions (the absolute rate of RBC transfusions)

  day of surgery until follow up visit 5 (up to 28 days)

Secondary Outcomes (9)

• change in hemoglobin level

  day of surgery until follow up visit 5 (up to 28 days)

• rate of transfused women with gynaecological carcinoma during and/or after surgery

  day of surgery until follow up visit 5 (up to 28 days)

• blood loss measured during surgery (ml)

  day of surgery

• rate of other blood product transfusions

  day of surgery until follow up visit 5 (up to 28 days)

• requirement of additional local or systematic haemostatic therapy (descriptive)

  day of surgery until follow up visit 5 (up to 28 days)

Study Arms (4)

ferric carboxymaltose

EXPERIMENTAL

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.

Drug: ferric carboxymaltose

tranexamic acid

EXPERIMENTAL

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

Drug: tranexamic acid

ferric carboxymaltose and tranexamic acid

EXPERIMENTAL

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.

Drug: ferric carboxymaltose and tranexamic acid

no treatment accordingly "current standard of care"

NO INTERVENTION

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

Interventions

ferric carboxymaltose 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.

ferric carboxymaltose

tranexamic acid 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.

tranexamic acid

ferric carboxymaltose and tranexamic acid 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.

ferric carboxymaltose and tranexamic acid

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Department of Obstetrics and Gynaecology, University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Interventions

ferric carboxymaltose; Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Gabriela Amstad Bencaiova, Dr. med.

  Department of Obstetrics and Gynaecology, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: November 12, 2020
• Study Start: August 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 14, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data will become available upon reasonable request for one month.

Locations

CH (1)