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Tranexamic Acid in Surgery of Advanced Ovarian Cancer

NCT00740116 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-03-15

Study results available
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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.

Conditions

Interventions

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 skin incision at surgery.

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 skin incision at surgery

Sponsors & Collaborators

  • Preben Kjolhede, MD, professor

    lead OTHER

Principal Investigators

  • Ulf Leandersson, MD · Dept. of Obstetrics and Gynecology, Kalmar Central Hospital, 391 85 Kalmar

  • Laila Falknäs, MD · Dept of Obstetrics and Gynecology, Ryhov Central Hospital, 58185 Jönköping

  • Preben Kjölhede, MD,PhD · Department of Obstetrics and Gynecology, University Hospital, Linköping

  • Torsten Johansson, MD, PhD · Dept. of Orthopedic Surgery, University Hospital, 58185 Linköping Sweden

  • Helena Zachrisson, MD,PhD · Dept of Physiology, University Hospital, 58185 Linköping Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • Sweden

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00740116 on ClinicalTrials.gov