Know Cancer

or
forgot password

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


Phase 4
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer

Thank you

Trial Information

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


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 ┬Ámol/l.

- Severe psychiatric dysfunction or mentally substantially disabled.

Type of Study:

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

Outcome Measure:

Perioperative bleeding volume

Outcome Time Frame:

From start of operation to discharge from hospital

Safety Issue:

No

Principal Investigator

Ulf Leandersson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dept. of Obstetrics and Gynecology, Kalmar Central Hospital, 391 85 Kalmar

Authority:

Sweden: Medical Products Agency

Study ID:

EudraCT nr 2006-006714-14

NCT ID:

NCT00740116

Start Date:

March 2008

Completion Date:

June 2012

Related Keywords:

  • Ovarian Cancer
  • Tumor of ovary
  • Surgical blood loss
  • Postoperative blood loss
  • Preventive therapy
  • Thromboembolism
  • Ovarian Neoplasms

Name

Location