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Completed

NCT Number: NCT00740116

Tranexamic Acid in Surgery of Advanced Ovarian Cancer

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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Blood Loss, Surgical Cardiovascular Diseases Embolism and Thrombosis Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Hemorrhage Intraoperative Complications Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Hemorrhage Thromboembolism Urogenital Diseases Urogenital Neoplasms Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Dept of Obstetric and Gynecology, Ryhov Central Hospital, Jönköping, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tranexamic Acid

Drug

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

Other names: Cyklokapron, ATC-code B02AA02

0.9% NaCl solution

Drug

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.

Other names: 0.9 % sodium chloride, ATC-code B05BB01

Primary outcomes

  1. Perioperative Bleeding Volume

    Time frame: 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 outcomes

  1. Number of Patients Receiving Blood Transfusions

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

    Total number of RBC-transfused women in each group

  2. Number of Units of Red Blood Cells (RBC) Transfused

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

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

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

    Time frame: 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

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

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

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

Sponsors and collaborators

Lead sponsor

Preben Kjolhede, MD, professor

Other

Registry information

Official study title

Tranexamic Acid in Surgery of Advanced Ovarian Cancer - a Prospective Randomized Double Blind Placebo Controlled Study

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Aug 22, 2008
Registry last updated
Mar 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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