Comparison of different dosing of Tranexamic Acid during major orthopedic surgery.

Phase 1

• Conditions: Blood loss in patients undergoing elective total hip or knee arthroplasty.; MedDRA version: 20.1 Level: LLT Classification code 10053220 Term: Hip injury System Organ Class: 100000004863; MedDRA version: 20.1 Level: LLT Classification code 10049032 Term: Knee injury System Organ Class: 100000004863; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2018-003537-15-AT
• Lead Sponsor: Medical University Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-16
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 180

Inclusion Criteria

•Undergoing elective total hip or knee arthroplasty under general anaesthesia
•Age = 18 years
•Written informed consent given
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Allergy to Tranexamic Acid
•Acute venous or arterial thrombosis (eg. myocardial infarction, stroke) within the past six months
•Renal impairment (eGFR <60?ml/min/1.73?m2)
•Untreated or not sufficient treatable convulsions
•Pregnancy
•Patient not able to understand study procedures

Study & Design

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