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Perioperative Management in Gynaecological Carcinoma Surgery

Primary Purpose

Gynaecological Carcinoma

Status

Recruiting

Phase

Phase 3

Locations

Switzerland

Study Type

Interventional

Intervention

ferric carboxymaltose

tranexamic acid

ferric carboxymaltose and tranexamic acid

About this trial

This is an interventional treatment trial for Gynaecological Carcinoma focused on measuring ferric carboxymaltose, tranexamic acid, RBC transfusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Department of Obstetrics and Gynaecology, University Hospital BaselRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Arm Label

ferric carboxymaltose

tranexamic acid

ferric carboxymaltose and tranexamic acid

no treatment accordingly "current standard of care"

Arm 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.

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

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.

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

change in hemoglobin level

change in hemoglobin level (g/dl)

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

blood loss measured during surgery (ml)

rate of other blood product transfusions

rate of other blood product transfusions (fresh frozen plasma, autologous whole blood)

requirement of additional local or systematic haemostatic therapy (descriptive)

duration of surgery (minutes)

duration of hospitalisation (days)

number of postoperative complications

number of postoperative complications: abdominal pain, haemorrhage, reoperation owing to bleeding, wound infection, pulmonary complications, postoperative renal dysfunction, systemic sepsis

postoperative mortality

Full Information

NCT ID

NCT04625530

First Posted

November 4, 2020

Last Updated

August 10, 2022

Sponsor

University Hospital, Basel, Switzerland

1. Study Identification

Unique Protocol Identification Number

NCT04625530

Brief Title

Perioperative Management in Gynaecological Carcinoma Surgery

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

August 1, 2021 (Actual)

Primary Completion Date

August 1, 2023 (Anticipated)

Study Completion Date

August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gynaecological Carcinoma

Keywords

ferric carboxymaltose, tranexamic acid, RBC transfusion

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ferric carboxymaltose

Arm Type

Experimental

Arm 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.

Arm Title

tranexamic acid

Arm Type

Experimental

Arm Description

Arm Title

ferric carboxymaltose and tranexamic acid

Arm Type

Experimental

Arm Description

Arm Title

no treatment accordingly "current standard of care"

Arm Type

No Intervention

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

ferric carboxymaltose

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

tranexamic acid

Intervention 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. The colour of the medicament is transparent.

Intervention Type

Drug

Intervention Name(s)

ferric carboxymaltose and tranexamic acid

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

change in hemoglobin level

Description

change in hemoglobin level (g/dl)

Time Frame

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

Title

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

Description

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)

Title

blood loss measured during surgery (ml)

Description

blood loss measured during surgery (ml)

Time Frame

day of surgery

Title

rate of other blood product transfusions

Description

rate of other blood product transfusions (fresh frozen plasma, autologous whole blood)

Time Frame

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

Title

requirement of additional local or systematic haemostatic therapy (descriptive)

Description

requirement of additional local or systematic haemostatic therapy (descriptive)

Time Frame

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

Title

duration of surgery (minutes)

Description

duration of surgery (minutes)

Time Frame

day of surgery

Title

duration of hospitalisation (days)

Description

duration of hospitalisation (days)

Time Frame

from admission to discharge date (up to 56 days)

Title

number of postoperative complications

Description

number of postoperative complications: abdominal pain, haemorrhage, reoperation owing to bleeding, wound infection, pulmonary complications, postoperative renal dysfunction, systemic sepsis

Time Frame

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

Title

postoperative mortality

Description

postoperative mortality

Time Frame

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gabriela Amstad Bencaiova, Dr. med.

Phone

+41 61 556 59 22

gabriela.amstad@usb.ch

First Name & Middle Initial & Last Name or Official Title & Degree

Viola Heinzelmann, Prof. Dr. med.

viola.heinzelmann@usb.ch

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gabriela Amstad Bencaiova, Dr. med.

Organizational Affiliation

Department of Obstetrics and Gynaecology, University Hospital Basel

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Obstetrics and Gynaecology, University Hospital Basel

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gabriela Amstad Bencaiova, Dr. med.

Phone

+41 61 556 59 22

gabriela.amstad@usb.ch

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Learn more about this trial

Perioperative Management in Gynaecological Carcinoma Surgery

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