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Testing of the Drug Tranexamic Acids as Prophylaxis of Bleeding in Benign Surgical Removal of the Uterus

NCT01940419 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 332

Last updated 2015-10-22

No results posted yet for this study

Summary

In Denmark, 4400 women annually undergo hysterectomy on benign background (surgical removal of the uterus). 10% of these women experience bleeding complications. The drug Tranexamic Acid (Cyklokapron) has showed significant reduction of bleeding in relation to other types of surgery. The hypothesis of this study is that Tranexamic Acid could also reduce the operative bleeding associated with benign hysterectomy. The study will be carried out as a randomized, placebo-controlled national multicenter trial

Conditions

  • Gynecologic Surgical Procedures
  • Hysterectomy
  • Tranexamic Acid

Interventions

DRUG

Tranexamic Acid

1g Tranexamic acid iv administered over 10 minutes just before surgery

DRUG

Placebo

10 ml sodium chloride iv administered over 10 minutes just before surgery

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Odense University Hospital

    collaborator OTHER

  • Central Denmark Region

    collaborator OTHER

  • Research grant from Nordsjællands Hospital

    collaborator UNKNOWN

  • The fund of Olga Bryde

    collaborator UNKNOWN

  • The Danish hysterectomy and hysteroscopy database

    collaborator UNKNOWN

  • Hillerod Hospital, Denmark

    lead OTHER

Principal Investigators

  • Märta F Topsøe, DM · Department of gynecology and obstetrics, Nordsjællands Hospital, 3400 Hillerød

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-11-30
Completion
2015-10-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

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 NCT01940419 on ClinicalTrials.gov