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Tranexamic Acid in Surgery of Advanced Ovarian Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Preben Kjolhede, University Hospital, Linkoeping
ClinicalTrials.gov Identifier:
NCT00740116
First received: August 21, 2008
Last updated: June 26, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention Phase
Ovarian Cancer
 Drug: Tranexamic acid
Drug: 0.9% NaCl solution
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tranexamic Acid in Surgery of Advanced Ovarian Cancer - a Prospective Randomized Double Blind Placebo Controlled Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Linkoeping:

Primary Outcome Measures:
  • Perioperative bleeding volume [ Time Frame: From start of operation to discharge from hospital ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients receiving blood transfusions and number of transfusions [ Time Frame: start of operation to discharge from hospital ] [ Designated as safety issue: No ]
  • Number of patients with clinically or radiologically verified thromboembolic events within 5 week postoperatively [ Time Frame: From time of operation to 5 weeks postoperatively. ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: March 2008
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00740116

Locations
Sweden
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
Investigators
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
  More Information

Publications:
Nadler S B, Hidalgo J U, Bloch T. Prediction of blood volume in normal human adults. Surgery 1962: 51: 224-32.

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
Study First Received: August 21, 2008
Last Updated: June 26, 2012
Health Authority: Sweden: Medical Products Agency

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

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
 Gonadal Disorders
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013