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Tranexamic Acid in Surgery of Advanced Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT00740116
Recruitment Status : Completed
First Posted : August 22, 2008
Last Update Posted : June 28, 2012
Information provided by (Responsible Party):
Preben Kjolhede, University Hospital, Linkoeping

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Tranexamic acid Drug: 0.9% NaCl solution Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tranexamic Acid in Surgery of Advanced Ovarian Cancer - a Prospective Randomized Double Blind Placebo Controlled Study
Study Start Date : March 2008
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Tranexamic acid
Drug: Tranexamic acid
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 scin incision at surgery
Other Name: Cyklokapron, ATC-code: B02AA02
Placebo Comparator: 2
0.9% NaCl solution
Drug: 0.9% NaCl solution
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 scin incision at surgery.
Other Name: Natriumklorid lösning; ATC-code: B05BB01

Primary Outcome Measures :
  1. Perioperative bleeding volume [ Time Frame: From start of operation to discharge from hospital ]

Secondary Outcome Measures :
  1. Number of patients receiving blood transfusions and number of transfusions [ Time Frame: start of operation to discharge from hospital ]
  2. Number of patients with clinically or radiologically verified thromboembolic events within 5 week postoperatively [ Time Frame: From time of operation to 5 weeks postoperatively. ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00740116

Dept of Obstetric and Gynecology, Ryhov Central Hospital
Jönköping, Sweden, 55185
Department of Obstetrics and Gynecology, Kalmar Central Hospital
Kalmar, Sweden, 39185
University Hospital, Department of Obsterics and Gynecology,
Linköping, Sweden, 581 85
Sponsors and Collaborators
Preben Kjolhede
Principal Investigator: Ulf Leandersson, MD Dept. of Obstetrics and Gynecology, Kalmar Central Hospital, 391 85 Kalmar
Principal Investigator: Laila Falknäs, MD Dept of Obstetrics and Gynecology, Ryhov Central Hospital, 58185 Jönköping
Study Chair: Preben Kjölhede, MD,PhD Department of Obstetrics and Gynecology, University Hospital, Linköping
Study Chair: Torsten Johansson, MD, PhD Dept. of Orthopedic Surgery, University Hospital, 58185 Linköping Sweden
Study Chair: Helena Zachrisson, MD,PhD Dept of Physiology, University Hospital, 58185 Linköping Sweden


Responsible Party: Preben Kjolhede, Associate professor, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT00740116     History of Changes
Other Study ID Numbers: EudraCT nr 2006-006714-14
First Posted: August 22, 2008    Key Record Dates
Last Update Posted: June 28, 2012
Last Verified: June 2012

Keywords provided by Preben Kjolhede, University Hospital, Linkoeping:
Tumor of ovary
Surgical blood loss
Postoperative blood loss
Preventive therapy

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Pharmaceutical Solutions
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action