Tranexamic Acid in Surgery of Advanced Ovarian Cancer

Preben Kjolhede, MD, professor

Status and phase: Completed; Phase 4

Conditions: Ovarian Cancer

Treatments: Drug: 0.9% NaCl solution; Drug: Tranexamic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT00740116

EudraCT nr 2006-006714-14

Details and patient eligibility

About

The purpose of the study is to determine if a standardized single dose tranexamic acid given intravenously immediately preoperatively reduces the perioperative bleeding volume and reduces the need of blood transfusion in women undergoing surgery for advanced ovarian cancer.

Enrollment: 100 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Females ages 18 or older with a pelvic or abdominal tumor suspected or histopathologically proven ovarian cancer FIGO stage II-IV who are undergoing primary surgery with the intention of performing optimal cytoreductive radical surgery.
• Understand and speak Swedish
• Accept participation in the study after written and verbal information and sign informed consent.

Exclusion criteria

• Allergy to tranexamic acid
• Having had tranexamic acid within the recent 30 days
• Previous or present episode of thromboembolic events .
• Previous or present treatment within the recent 3 months with anticoagulant.
• Previous or present known coagulopathy
• Myocardial infarction within the previous 12 months or instable angina pectoris which, according to the investigator, may increase the risk for complications significantly in case of a lowering of the hemoglobin.
• Significant renal failure with serum-creatinine > 250 µmol/l.
• Severe psychiatric dysfunction or mentally substantially disabled.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

The Tranexamic acid group

Active Comparator group

Description:

The group of women receiving Tranexamic acid intravenously immediately before the surgery

Treatment:

Drug: Tranexamic acid

The placebo group

Placebo Comparator group

Description:

The group of women receiving saline solution (0.9% NaCl) intravenously immediately before the surgery

Treatment:

Drug: 0.9% NaCl solution