Tranexamic Acid in Surgery of Advanced Ovarian Cancer

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Preben Kjolhede
• Treatments: Pharmaceutical Solutions; Tranexamic Acid

Criteria

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.