Perioperative Management in Gynaecological Carcinoma Surgery

April 11, 2025 updated by: University Hospital, Basel, Switzerland

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Department of Obstetrics and Gynaecology, University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ferric carboxymaltose
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
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.
Experimental: 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
Drug: 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.
Experimental: ferric carboxymaltose and tranexamic acid

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
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.
No Intervention: no treatment accordingly "current standard of care"
no treatment accordingly "current standard of care" will be given

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
number of all perioperative (intraoperative and postoperative) administered RBC transfusions
Time Frame: day of surgery until follow up visit 5 (up to 28 days)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
change in hemoglobin level
Time Frame: day of surgery until follow up visit 5 (up to 28 days)
change in hemoglobin level (g/dl)
day of surgery until follow up visit 5 (up to 28 days)
rate of transfused women with gynaecological carcinoma during and/or after surgery
Time Frame: 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)
Time Frame: day of surgery
blood loss measured during surgery (ml)
day of surgery
rate of other blood product transfusions
Time Frame: day of surgery until follow up visit 5 (up to 28 days)
rate of other blood product transfusions (fresh frozen plasma, autologous whole blood)
day of surgery until follow up visit 5 (up to 28 days)
requirement of additional local or systematic haemostatic therapy (descriptive)
Time Frame: 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)
duration of surgery (minutes)
Time Frame: day of surgery
duration of surgery (minutes)
day of surgery
duration of hospitalisation (days)
Time Frame: from admission to discharge date (up to 56 days)
duration of hospitalisation (days)
from admission to discharge date (up to 56 days)
number of postoperative complications
Time Frame: day of surgery until follow up visit 5 (up to 28 days)
number of postoperative complications: abdominal pain, haemorrhage, reoperation owing to bleeding, wound infection, pulmonary complications, postoperative renal dysfunction, systemic sepsis
day of surgery until follow up visit 5 (up to 28 days)
postoperative mortality
Time Frame: day of surgery until follow up visit 5 (up to 28 days)
postoperative mortality
day of surgery until follow up visit 5 (up to 28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Basel, Switzerland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gabriela Amstad Bencaiova, Dr. med., Department of Obstetrics and Gynaecology, University Hospital Basel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 4, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020-01194; sp20Amstad

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data generated by our research will be available as soon as possible, wherever legally and ethically possible. The data will be made available upon reasonable request. The deidentified participant data from this study and related documents (study protocol, statistical analysis plan, patient consent form) will be made available upon request. Researchers may request data to repeat the analyses or use the data for secondary analyses (e. g., systematic review and meta-analysis). Changes to this plan will be noted in the Data Availability Statement and updated in the registry record (to comply with ICMJE recommendations).

IPD Sharing Time Frame

The data will become available upon reasonable request for one month.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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