Tranexamic Acid in Surgery of Advanced Ovarian Cancer

Preben Kjolhede, MD, professor100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

100

Conditions

Ovarian Cancer

Interventions

Tranexamic acidDRUG

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 solutionDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (3)

Dept of Obstetric and Gynecology, Ryhov Central Hospital

Jönköping, Sweden

Department of Obstetrics and Gynecology, Kalmar Central Hospital

Kalmar, Sweden

University Hospital, Department of Obsterics and Gynecology,

Linköping, Sweden

Outcomes

Primary Outcomes

Perioperative Bleeding Volume

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.

Time frame: From start of operation to discharge from hospital, up to 5 weeks

Secondary Outcomes

Number of Patients Receiving Blood Transfusions

Total number of RBC-transfused women in each group

Time frame: From start of operation to discharge from hospital, up to 5 weeks

Number of Units of Red Blood Cells (RBC) Transfused

Total number of red blood cells (RBC) transfused across all participants

Time frame: From start of operation to discharge from hospital, up to 5 weeks

Median Number of Transfused Units of Red Blood Cells (RBC)

Median number of red blood cells transfused among those who received RBC transfusions

Time frame: From start of operation to discharge from hospital, up to 5 weeks

Number of Patients With Clinically or Radiologically Verified Thromboembolic Events Within 5 Weeks Postoperatively

Thromboembolic events including arterial thrombosis, muscle vein thrombosis, superficial and deep venous thrombosis.

Time frame: From time of operation to 5 weeks postoperatively.

Data from ClinicalTrials.gov

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