Topical and Intravenous Administration of TXA Are Equally Effective in DAA THA

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Through a randomized controlled trial, we will compare the intravenous administration of tranexamic acid with the intra-articular application after a total hip arthroplasty through direct anterior approach.

• RCT, prospective study

• Academic-monocentric study

• Clinical outcome measurements The postoperative blood loss will be the primary outcome. Secondary outcomes are

1. The rate of perioperative and postoperative blood transfusion

2. The number of blood units transfused

3. The length of hospital stay

4. Perioperative given intravenous isotonic fluid

The Null-hypothesis is that there is no significant difference in postoperative blood loss between intra-articular and intravenous administration of TXA.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ziekenhuis Oost-Limburg
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

• participation in another clinical trial