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JOURNAL ONKOLOGIE – STUDIE

Perioperative Management in Gynaecological Carcinoma Surgery

Rekrutierend

NCT-Nummer:
NCT04625530

Studienbeginn:
Februar 2021

Letztes Update:
12.11.2020

Wirkstoff:
ferric carboxymaltose, tranexamic acid, ferric carboxymaltose and tranexamic acid

Indikation (Clinical Trials):
Carcinoma

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
University Hospital, Basel, Switzerland

Collaborator:
-

Studienleiter

Gabriela Amstad Bencaiova, Dr. med.
Principal Investigator
Department of Obstetrics and Gynaecology, University Hospital Basel

Kontakt

Studienlocations (1 von 1)

Department of Obstetrics and Gynaecology, University Hospital Basel
4031 Basel
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Gabriela Amstad Bencaiova, Dr. med.
Phone: +41 61 556 59 22
E-Mail: gabriela.amstad@usb.ch
» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. 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)



Secondary outcome:

1. change in hemoglobin level (Time Frame - day of surgery until follow up visit 5 (up to 28 days)):
change in hemoglobin level (g/dl)

2. 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

3. blood loss measured during surgery (ml) (Time Frame - day of surgery):
blood loss measured during surgery (ml)

4. 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)

5. 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)

6. duration of surgery (minutes) (Time Frame - day of surgery):
duration of surgery (minutes)

7. duration of hospitalisation (days) (Time Frame - from admission to discharge date (up to 56 days)):
duration of hospitalisation (days)

8. 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

9. postoperative mortality (Time Frame - day of surgery until follow up visit 5 (up to 28 days)):
postoperative mortality

Studien-Arme

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

Geprüfte Regime

  • 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.
  • 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.
  • 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.

Quelle: ClinicalTrials.gov


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