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NCT01622946 Clinical Trial

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

Total Hip Arthroplasty Clinical Trial

Official title:
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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01622946
Other study ID # 2010-024410-59
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date April 2012
Est. completion date April 2020

Study information
Verified date November 2020
Source Universitaire Ziekenhuizen Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date April 2020
Est. primary completion date April 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Tranexamic Acid
3g of tranexamic acid is topically applied after THA. The drugs is left for 15 minutes or 2 hours
• 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

Locations
Country Name City State
Belgium UZ Pellenberg Pellenberg

Sponsors (1)
Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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