The Effect of Topical Application of Tranexamic Acid in Total Hip Arthroplasty Through the Direct Anterior Approach

The Effect of Topical Application of Tranexamic Acid in Total Hip Arthroplasty Through the Direct Anterior Approach. A Prospective, Double Blind, Placebo-controlled Clinical Trial.

The effects of topical application of 3g tranexamic acid for 2 hours prior to opening of the suction drain following a total hip replacement

Study Overview

• Status: Completed
• Conditions: Total Hip Arthroplasty; Postoperative Blood Loss
• Intervention / Treatment: Drug: placebo; Drug: Tranexamic Acid

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Pellenberg, Belgium
    • UZ Pellenberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients who will receive a unilateral total hip arthroplasty

Exclusion Criteria:

• coagulopathy
• allergy to tranexamic acid
• preoperative anemia (a hemoglobin value of < 11g/dL in females and < 12g/dL in males)
• fibrinolytic disorders
• a history of arterial or venous thromboembolic disease
• pregnancy
• breastfeeding
• major comorbidities

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Placebo; The patients who receive placebo form the control group. The results can be compared with the results of the patients who did receive TXA	Drug: placebo; The patients will receive 3g topical TXA for 15 minutes or 2 hours after THA. 33% of the patients will receive 3g of TXA trough a suction drain for 15 minutes after total hip arthroplasty, then the suction drain is opened. 33% will receive the same amount of TXA but the suction drain will only be opened 2 hours after application. The other patients will receive a placebo in the same manner
Placebo Comparator: Tranexamic acid; The patients will receive 3g topical TXA for 15 minutes or 2 hours after THA. 33% of the patients will receive 3g of TXA trough a suction drain for 15 minutes after total hip arthroplasty, then the suction drain is opened. 33% will receive the same amount of TXA but the suction drain will only be opened 2 hours after application. The other patients will receive a placebo in the same manner	Drug: Tranexamic Acid; 3g of tranexamic acid is topically applied after THA. The drugs is left for 15 minutes or 2 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
postoperative blood loss in patients undergoing primary total hip arthroplasty	Haemoglobin levels, on which the postopererative blood loss is calculated, is measured preoperative and on day 1 and 4 postoperative

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2012
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: June 14, 2012
• First Submitted That Met QC Criteria: June 18, 2012
• First Posted (Estimate): June 19, 2012

Study Record Updates

• Last Update Posted (Actual): November 5, 2020
• Last Update Submitted That Met QC Criteria: November 4, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: total hip arthroplasty; tranexamic acid; postoperative blood loss
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Hemorrhage; Postoperative Hemorrhage; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 2010-024410-59