Clinical trial NCT00740116: Tranexamic Acid in Surgery of Advanced Ovarian Cancer
Official title: Tranexamic Acid in Surgery of Advanced Ovarian Cancer - a Prospective Randomized Double Blind Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ovarian Cancer
Keywords: Tumor of ovary
Surgical blood loss
Postoperative blood loss
Preventive therapy
Thromboembolism
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2008-08-22
Enrollment: 100
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: 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.


Eligibility 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.

Primary outcomes:
measure: Perioperative Bleeding Volume
timeFrame: From start of operation to discharge from hospital, up to 5 weeks
Secondary outcomes:
measure: Number of Patients Receiving Blood Transfusions
timeFrame: From start of operation to discharge from hospital, up to 5 weeks
measure: Number of Units of Red Blood Cells (RBC) Transfused
timeFrame: From start of operation to discharge from hospital, up to 5 weeks
measure: Median Number of Transfused Units of Red Blood Cells (RBC)
timeFrame: From start of operation to discharge from hospital, up to 5 weeks
measure: Number of Patients With Clinically or Radiologically Verified Thromboembolic Events Within 5 Weeks Postoperatively
timeFrame: From time of operation to 5 weeks postoperatively.
Other outcomes:
Locations:
city: Jönköping
country: Sweden
facility: Dept of Obstetric and Gynecology, Ryhov Central Hospital
city: Kalmar
country: Sweden
facility: Department of Obstetrics and Gynecology, Kalmar Central Hospital
city: Linköping
country: Sweden
facility: University Hospital, Department of Obsterics and Gynecology,
Study officials:
affiliation: Dept. of Obstetrics and Gynecology, Kalmar Central Hospital, 391 85 Kalmar
name: Ulf Leandersson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept of Obstetrics and Gynecology, Ryhov Central Hospital, 58185 Jönköping
name: Laila Falknäs, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Obstetrics and Gynecology, University Hospital, Linköping
name: Preben Kjölhede, MD,PhD
role: STUDY_CHAIR
affiliation: Dept. of Orthopedic Surgery, University Hospital, 58185 Linköping Sweden
name: Torsten Johansson, MD, PhD
role: STUDY_CHAIR
affiliation: Dept of Physiology, University Hospital, 58185 Linköping Sweden
name: Helena Zachrisson, MD,PhD
role: STUDY_CHAIR
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