Completed

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

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What is being tested

Tranexamic acid

+ 0.9% NaCl solution

Drug
Who is being recruted

Urogenital Diseases+23

+ Genital Diseases

+ Adnexal Diseases

Over 18 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: March 2008
See protocol details

Summary

Principal SponsorPreben Kjolhede, MD, professor
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2008

Actual date on which the first participant was enrolled.

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.

Official TitleTranexamic Acid in Surgery of Advanced Ovarian Cancer - a Prospective Randomized Double Blind Placebo Controlled Study
NCT00740116
Principal SponsorPreben Kjolhede, MD, professor
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesAdnexal DiseasesCardiovascular DiseasesEndocrine System DiseasesEndocrine Gland NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleGonadal DisordersHemorrhageIntraoperative ComplicationsNeoplasmsNeoplasms by SiteOvarian DiseasesOvarian NeoplasmsPathologic ProcessesPostoperative ComplicationsPathological Conditions, Signs and SymptomsThromboembolismUrogenital NeoplasmsVascular DiseasesBlood Loss, SurgicalEmbolism and ThrombosisPostoperative HemorrhageFemale Urogenital Diseases

Criteria

3 inclusion criteria required to participate
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.
8 exclusion criteria prevent from participating
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.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
The group of women receiving Tranexamic acid intravenously immediately before the surgery

Group II

Placebo
The group of women receiving saline solution (0.9% NaCl) intravenously immediately before the surgery

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

Dept of Obstetric and Gynecology, Ryhov Central Hospital

Jönköping, SwedenOpen Dept of Obstetric and Gynecology, Ryhov Central Hospital in Google Maps
Suspended

Department of Obstetrics and Gynecology, Kalmar Central Hospital

Kalmar, Sweden
Suspended

University Hospital, Department of Obsterics and Gynecology,

Linköping, Sweden
Completed3 Study Centers