Clinical trial NCT04625530: 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
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Gynaecological Carcinoma
Keywords: ferric carboxymaltose
tranexamic acid
RBC transfusion
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-11-12
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: number of all perioperative (intraoperative and postoperative) administered RBC transfusions
timeFrame: day of surgery until follow up visit 5 (up to 28 days)
Secondary outcomes:
measure: change in hemoglobin level
timeFrame: day of surgery until follow up visit 5 (up to 28 days)
measure: rate of transfused women with gynaecological carcinoma during and/or after surgery
timeFrame: day of surgery until follow up visit 5 (up to 28 days)
measure: blood loss measured during surgery (ml)
timeFrame: day of surgery
measure: rate of other blood product transfusions
timeFrame: day of surgery until follow up visit 5 (up to 28 days)
measure: requirement of additional local or systematic haemostatic therapy (descriptive)
timeFrame: day of surgery until follow up visit 5 (up to 28 days)
measure: duration of surgery (minutes)
timeFrame: day of surgery
measure: duration of hospitalisation (days)
timeFrame: from admission to discharge date (up to 56 days)
measure: number of postoperative complications
timeFrame: day of surgery until follow up visit 5 (up to 28 days)
measure: postoperative mortality
timeFrame: day of surgery until follow up visit 5 (up to 28 days)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Obstetrics and Gynaecology, University Hospital Basel
Study officials:
affiliation: Department of Obstetrics and Gynaecology, University Hospital Basel
name: Gabriela Amstad Bencaiova, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: