Status:
COMPLETED
Tranexamic Acid in Surgery of Advanced Ovarian Cancer
Lead Sponsor:
Preben Kjolhede, MD, professor
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00740116
Start Date
March 1 2008
End Date
June 1 2012
Last Update
March 15 2022
Active Locations (3)
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1
Dept of Obstetric and Gynecology, Ryhov Central Hospital
Jönköping, Sweden, 55185
2
Department of Obstetrics and Gynecology, Kalmar Central Hospital
Kalmar, Sweden, 39185
3
University Hospital, Department of Obsterics and Gynecology,
Linköping, Sweden, 581 85