Effect of prophylactic Tranexasyre of bleeding in relation to benign surgical removal of the uterus - a clinical trial

Phase 1

• Conditions: Bleeding related to benign hysterectomy; MedDRA version: 14.1Level: LLTClassification code 10066252Term: Total vaginal hysterectomySystem Organ Class: 100000004865; MedDRA version: 14.1Level: LLTClassification code 10046913Term: Vaginal hysterectomySystem Organ Class: 100000004865; MedDRA version: 14.1Level: LLTClassification code 10021152Term: Hysterectomy (ovaries conserved)System Organ Class: 100000004865; MedDRA version: 14.1Level: LLTClassification code 10057318Term: Total hysterectomySystem Organ Class: 100000004865; MedDRA version: 14.1Level: LLTClassification code 10059806Term: OvariohysterectomySystem Organ Class: 100000004865; MedDRA version: 14.1Level: LLTClassification code 10000075Term: Abdominal hysterectomySystem Organ Class: 100000004865; MedDRA version: 14.1Level: LLTClassification code 10027801Term: Modified vaginal hysterectomySystem Organ Class: 100000004865; MedDRA version: 14.1Level: LLTClassification code 10023692Term: Laparoscopically assisted hysterectomySystem Organ Class: 100000004865; MedDRA version: 14.1Level: LLTClassification code 10044080Term: Total abdominal hysterectomySystem Organ Class: 100000004865

• Registration Number: EUCTR2012-005407-40-DK
• Lead Sponsor: Thomas Bergholt

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-09
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 314

Inclusion Criteria

All women above 18 years of age to undergo elective benign hysterectomy during the study period should be invited to participate.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 214
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

• Known thrombophilia
• Active / previous thromboembolic disease
• Family history to thromboembolic disease (thrombophilia in the family)
• Hypersensitivity to Tranexamic acid
• Impaired renal function
• Ongoing hematuria
• Subarachnoid hemorrhage
• Daily use of anticoagulant medication
• Preoperative use of Tranexamic acid within 24 hours before surgery
• Known malignancy or hysterectomy as part of the investigation of suspected malignancy
• Insufficient understanding of the information concerning the project

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The purpose of the study is primarily to investigate Tranexamic acid's impact on preventing perioperative bleeding in benign hysterectomy. This will be investigated both by individual assessment of the intraoperative bleeding in ml, and by using relevant quantitative and qualitative secondary endpoints. The results are also expected to indicate a possible effect of Tranexamic acid on the number of actual intra- and postoperative bleeding complications, and may in this respect be considered as a pilot study. ;Secondary Objective: Not applicable;Primary end point(s): The primary endpoint is the difference in intraoperative bleeding in benign hysterectomy in the group treated with prophylactic Tranexamic acid compared with placebo. The objective of the study is a 25% reduction of this bleeding.<br>;Timepoint(s) of evaluation of this end point: The intraoperative bleeding is measured from the start of the operation and to its completion.<br>