CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 332 enrolled
Drug / intervention
Tranexamic Acid +1 moredrug
Likely dose
Tranexamic Acid 1gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01940419
NCT01940419Phase 4Completed
CompareCT.gov

Peroperative Tranexamic Acid as Prophylaxis of Haemorrhage in Benign Hysterectomy - a Randomized, Placebo-controlled Trial

Hillerod Hospital, Denmark·interventional·Posted Sep 12, 2013·Updated Oct 22, 2015

In Brief

A Phase 4 clinical trial evaluating Tranexamic Acid and Placebo for Gynecologic Surgical Procedures and 2 related conditions. Completed, enrolled 332 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGynecologic Surgical Procedures, Hysterectomy, Tranexamic Acid
CountriesDenmark
CollaboratorsRigshospitalet, Denmark, Odense University Hospital, Central Denmark Region, Research grant from Nordsjællands Hospital, The fund of Olga Bryde, The Danish hysterectomy and hysteroscopy database

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 12, 2013
Enrollment StartApr 1, 2013
Primary CompletionNov 1, 2014
Study CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 12.8 years ago

Interventions

Tranexamic Aciddrug

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

Placebodrug

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