Topical (intraarticular) application of tranexamic acid, a drug used to stop the bleeding after orthopedic surgery, compared to the intravenous administration in total hip arthroplasty with the direct anterior approach. A prospective, randomized, clinical trial.
- Conditions
- All adults (+ 18 yrs) who were scheduled for a primary unilateral total hip arthroplasty due to osteoarthritis.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
- Registration Number
- EUCTR2013-004623-36-BE
- Lead Sponsor
- Ziekenhuis Oost-Limburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
All adults (patients over the age of eighteen years) who were scheduled for a primary unilateral total hip arthroplasty due to osteoarthritis at Ziekenhuis Oost-Limburg, Genk, Belgium are eligible for inclusion in the study.
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
A patient is excluded from the study if he or she has a history of coagulopathy, allergy to tranexamic acid, preoperative anemia, fibrinolytic disorders, history of arterial or venous thromboembolic disease, disturbances of color vision, pregnancy, breastfeeding, major comorbidities and participation in another clinical trial.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: Not applicable;Primary end point(s): The primary outcome is the postoperative blood loss. The difference between total blood loss and intraoperative blood loss is used to predict the postoperative blood loss for each patient. ;Timepoint(s) of evaluation of this end point: Measured with a simple blood sample on day one after surgery;Main Objective: In this study, we will compare the efficacy of intra-articular application of TXA to the intravenous administration in terms of postoperative blood loss. <br>Our hypothesis is that there is no significant difference in postoperative blood loss between intra-articular and intravenous administration of TXA.<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The secondary outcomes includes:<br>1)The rate of perioperative and postoperative blood transfusions<br>2)The number of blood units transfused<br>3)The length of hospital stay<br>4)The severity of pain at rest as determined with use of a visual analog scale (possible range 0 to 10). <br>5)Perioperative given intravenous isotonic fluid<br>;Timepoint(s) of evaluation of this end point: 1)Patients will be followed for the duration of hospital stay, an expected average of 5 days<br>2)Patients will be followed for the duration of hospital stay, an expected average of 5 days<br>3)3)The length of hospital stay<br>4)Patients will be followed for the duration of hospital stay, an expected average of 5 days (0-10 scale)<br>5)Patients will be followed for the duration of hospital stay, an expected average of 5 days