Title
Tranexamic Acid in Surgery of Advanced Ovarian Cancer
Tranexamic Acid in Surgery of Advanced Ovarian Cancer - a Prospective Randomized Double Blind Placebo Controlled Study
Phase
Phase 4Lead Sponsor
Linkoping UniversityStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Ovarian CancerIntervention/Treatment
tranexamic acid sodium chloride ...Study Participants
100The 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.
Tranexamic acid, 100 mg/ml; 15 mg/kg body weight added to 100 ml 0.9% NaCl solution given as a single dose intravenously immediately prior to skin incision at surgery
0.9% NaCl solution; 0.15 ml/kg body weight added to 100 ml 0.9% NaCl solution. The volume is given intravenously immediate before skin incision at surgery.
The group of women receiving Tranexamic acid intravenously immediately before the surgery
The group of women receiving saline solution (0.9% NaCl) intravenously immediately before the surgery
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.
| Event Type | Organ System | Event Term | Tranexamic Group | Placebo Group |
|---|
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.
Thromboembolic events including arterial thrombosis, muscle vein thrombosis, superficial and deep venous thrombosis.
Total number of RBC-transfused women in each group
Total number of red blood cells (RBC) transfused across all participants
Median number of red blood cells transfused among those who received RBC transfusions
