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

Peroperative Tranexamic acid as prophylaxis of bleeding related to benign hysterectomy - a randomized, placebo-controlled trial - PeTraH-studiet

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-005407-40-DK

Enrollment

314

Registered

2013-01-09

Start date

2013-02-07

Completion date

Unknown

Last updated

2021-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bleeding related to benign hysterectomy MedDRA version: 14.1 Level: LLT Classification code 10066252 Term: Total vaginal hysterectomy System Organ Class: 100000004865 MedDRA version: 14.1 Level: LLT Classification code 10046913 Term: Vaginal hysterectomy System Organ Class: 100000004865 MedDRA version: 14.1 Level: LLT Classification code 10021152 Term: Hysterectomy (ovaries conserved) System Organ Class: 100000004865 MedDRA version: 14.1 Level: LLT Classification code 10057318 Term: Total hy

Interventions

Trade Name: Tranexamic acid Pharmaceutical Form: Concentrate and solvent for solution for injection/infusion INN or Proposed INN: Tranexamic acid Other descriptive name: TRANEXAMIC ACID Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. ;Timepoint(s) of evaluation of this end point: The intraoperative bleeding is measured from the start of the operation and to its completion.	—

Measure

Time frame

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. ;Timepoint(s) of evaluation of this end point: The intraoperative bleeding is measured from the start of the operation and to its completion.

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Occurence of bleeding = 1000 ml, use of trial-independent Tranexamic acid intraoperatively and duration of surgery is measured from the operatioens start and to its end. Hemoglobin decrease is measured from 3-0 days preoperatively to 4-12 hours postoperatively. The use of postoperatively trial-independent Tranexamic acid is observed until 24 hours postoperatively. Need for blood transfusion and use of painkillers is assessed during the primary hospitalization. Number of hospitalization days covers the primary hospitalization. Complicated pain-condition, need for re-operation, readmission to hospital and mortality is all assessed within 30 days postoperatively. The questionnaire survey will be carried out 30 days after surgery and covers the entire 30-day postoperative period. ;Secondary end point(s): • The incidence of perioperative bleeding = 1000 ml • Need for blood transfusion • Use of trials-independent Tranexamic acid intraoperatively • Duration of operation • Incidence of postoperative bleeding complications • Decrease of hemoglobin - from preoperatively to 4-12 hours postoperatively • Use of trials independent Tranexamic acid postoperatively (within 24 hours) • Consumption of pain medication during hospitalization • Complicating pain condition beyond the expected after hysterectomy • Number of hospitalization days • Need for re-operation • readmissions to a hospital • Mortality • Postoperative self-rated health and activity - questionnaire survey	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Occurence of bleeding = 1000 ml, use of trial-independent Tranexamic acid intraoperatively and duration of surgery is measured from the operatioens start and to its end. Hemoglobin decrease is measured from 3-0 days preoperatively to 4-12 hours postoperatively. The use of postoperatively trial-independent Tranexamic acid is observed until 24 hours postoperatively. Need for blood transfusion and use of painkillers is assessed during the primary hospitalization. Number of hospitalization days covers the primary hospitalization. Complicated pain-condition, need for re-operation, readmission to hospital and mortality is all assessed within 30 days postoperatively. The questionnaire survey will be carried out 30 days after surgery and covers the entire 30-day postoperative period. ;Secondary end point(s): • The incidence of perioperative bleeding = 1000 ml • Need for blood transfusion • Use of trials-independent Tranexamic acid intraoperatively • Duration of operation • Incidence of postoperative bleeding complications • Decrease of hemoglobin - from preoperatively to 4-12 hours postoperatively • Use of trials independent Tranexamic acid postoperatively (within 24 hours) • Consumption of pain medication during hospitalization • Complicating pain condition beyond the expected after hysterectomy • Number of hospitalization days • Need for re-operation • readmissions to a hospital • Mortality • Postoperative self-rated health and activity - questionnaire survey

—

Countries

Denmark

Contacts

Public ContactMärta Fink Topsøe

Hillerød Hospital, department of gynecology and obstetrics

Maerta.Topsoee-Jensen@regionh.dk004528 41 48 17

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026