Tranexamic Acid in Surgery of Advanced Ovarian Cancer
- Registration Number
- NCT00740116
- Lead Sponsor
- Preben Kjolhede, MD, professor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 100
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description The placebo group 0.9% NaCl solution The group of women receiving saline solution (0.9% NaCl) intravenously immediately before the surgery The Tranexamic acid group Tranexamic acid The group of women receiving Tranexamic acid intravenously immediately before the surgery
- Primary Outcome Measures
Name Time Method Perioperative Bleeding Volume From start of operation to discharge from hospital, up to 5 weeks Estimation of total blood loss was based on the estimation of the Hb balance method (Brecher, et al.1997) with the assumption that the body blood volume was normalised on the fifth postoperative day. The haemoglobin level was assessed preoperatively and on the fifth postoperative day. The predicted blood volume (PBV, l) was calculated according to the method described by Nadler et al. (1962), using body weight and height. The extravasation of haemoglobin was calculated taking into account allogenic transfused haemoglobin. Total blood loss perioperatively was related to the patient's preoperative haemoglobin value. Blood loss due to haematomas or a reoperation within the first five days after surgery was also considered.
- Secondary Outcome Measures
Name Time Method Number of Patients Receiving Blood Transfusions From start of operation to discharge from hospital, up to 5 weeks Total number of RBC-transfused women in each group
Number of Units of Red Blood Cells (RBC) Transfused From start of operation to discharge from hospital, up to 5 weeks Total number of red blood cells (RBC) transfused across all participants
Median Number of Transfused Units of Red Blood Cells (RBC) From start of operation to discharge from hospital, up to 5 weeks Median number of red blood cells transfused among those who received RBC transfusions
Number of Patients With Clinically or Radiologically Verified Thromboembolic Events Within 5 Weeks Postoperatively From time of operation to 5 weeks postoperatively. Thromboembolic events including arterial thrombosis, muscle vein thrombosis, superficial and deep venous thrombosis.
Trial Locations
- Locations (3)
Department of Obstetrics and Gynecology, Kalmar Central Hospital
🇸🇪Kalmar, Sweden
Dept of Obstetric and Gynecology, Ryhov Central Hospital
🇸🇪Jönköping, Sweden
University Hospital, Department of Obsterics and Gynecology,
🇸🇪Linköping, Sweden